Download:
pdf |
pdf1. NCI Clinical Trials Reporting Program Subject Accrual User's Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 1 - Getting Started with Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.1 About CTRP Subject Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.2 What's New in this Release of CTRP Subject Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.3 Obtaining a CTRP User Account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.4 Requesting Access to Your Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1.5 Logging In to the CTRP Accrual Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 2 - Searching for, and Selecting Your Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.1 Searching for Trials in Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2.2 Selecting Listed Trials in Accrual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3 3 - Working with Complete Trial Accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.1 Adding Study Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.1.1 Searching for Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.2 Searching for Study Subjects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.3 Reviewing Study Subject Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.4 Updating Study Subject Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.3.5 Deleting Study Subject Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.4 4 - Working with Abbreviated Trial Accruals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5 5 - Submitting Accrual Data Batch Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.1 Preparing CTRP Subject Accrual Batch Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.5.2 Uploading CTRP Subject Accrual Batch Data Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6 6 - Working with Prior Accrual Submission Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6.1 Accessing Trials with Prior Accruals Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6.2 Reviewing and Updating Prior Accrual Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.6.3 Downloading Submitted Subject Accrual Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.7 7 - Managing Your CTRP User Account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.8 8 - Common Tasks and Data Element Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.9 Appendix A - Accrual Data Elements for Complete Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.10 Appendix B - Accrual Data Elements for Abbreviated Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.11 Appendix C - Comparison of CTRP and CDUS Accrual Data Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.12 CTRP Subject Accrual Credits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
3
4
6
7
7
7
8
8
10
11
11
13
15
16
17
18
19
20
21
38
39
40
41
42
42
43
45
53
55
57
NCI Clinical Trials Reporting Program Subject Accrual
User's Guide
NCI Clinical Trials Reporting Program Subject Accrual User's Guide
Contents of this Page
About this Guide
Audience
Topics Covered
Application Support
Subject Accural Links
NCI CTRP Subject Accrual Site
Overview of CTRP Applications
CTRP Subject Accrual Site video tutorials
Accrual Batch File Utility (Excel)
CTRP Resources
CTRP Issue Tracker (JIRA) (Login required)
CTRP Website
ClinicalTrials.gov (http://clinicaltrials.gov)
PRS and U.S. Public Law 110-85 (http://prsinfo.clinicaltrials.gov/fdaaa.html)
Dictionary of cancer terms
Terminology resources
You can convert the wiki version of this guide to PDF for viewing and printing
For instructions refer to Printing multiple pages. If you want to print a single page, refer to Printin
g a page.
Some longer links may appear truncated when viewed in PDFs, but they work regardless.
Application Support
If you have problems with the program or have suggestions for any of the CTRP User Guides, contact
the NCI Clinical Trials Reporting Office using the information and guidelines provided in the Application
Support section below.
About this Guide
This guide provides instructions for using the NCI Clinical Trials Reporting Program Accrual site to report accrual
data for clinical studies registered with the CTRP (Clinical Trials Reporting Program).
Audience
This guide is designed for authorized users who want to view or submit accrual data for specific studies and sites.
Topics Covered
If you are new to NCI Clinical Trials Reporting Program Trial Registration Site, read this brief overview, which
explains what you will find in each chapter.
1 - Getting Started with Accrual introduces you to the NCI Clinical Trials Reporting Program Accrual (CTRP
Accrual) site, and provides instructions for creating an account and logging in to the system.
2 - Searching for, and Selecting Your Trials describes how to use the CTRP Accrual site to search for and
select the trials in the CTRP for which you want to provide new or updated accrual data.
3 - Working with Complete Trial Accruals provides instructions for searching for, adding, updating, and
deleting study subject records associated with complete clinical trials.
4 - Working with Abbreviated Trial Accruals provides instructions for submitting and updating the total number
of accruals associated with abbreviated clinical trials.
5 - Submitting Accrual Data Batch Files describes how to create and upload accrual data files singly as .TXT
files or in multiple files that have been compressed into a Zip file.
6 - Working with Prior Accrual Submission Records provides instructions for accessing, updating, and
downloading existing accruals.
7 - Managing Your CTRP User Account provides instructions for modifying your NCI CTRP Accrual Site
account.
8 - Common Tasks and Data Element Formats provides detailed instructions for tasks that are common to
many of the procedures included in this guide.
Appendix A - Accrual Data Elements for Complete Trials contains detailed information about each of the data
elements included in the Batch Upload file for Complete trials, including the CDUS Accepted Values.
Appendix B - Accrual Data Elements for Abbreviated Trials contains detailed information about each of the
data elements included in the Batch Upload file for Abbreviated trials, including the CDUS Accepted Values.
Appendix C - Comparison of CTRP and CDUS Accrual Data Elements lists CDUS data elements and
indicates which of them are captured in CTRP.
Application Support
If you have questions or comments regarding this document, or other CTRP topics, contact the Clinical Trials
Reporting Office (CTRO) at [email protected] as per the instructions below.
When submitting support requests, please include:
Your contact information, including your telephone number
The name of the application/tool you are using
The URL if it is a Web-based application
A description of the problem and steps to recreate it
The text of any error messages you have received
1 - Getting Started with Accrual
1 - Getting Started with Accrual
This section introduces you to the NCI Clinical Trials Reporting Program Accrual (CTRP Accrual) site, and provides
instructions for creating an account and logging in to the system.
This section includes the following topics:
About CTRP Subject Accrual
What's New in this Release of CTRP Subject Accrual
Obtaining a CTRP User Account
Requesting Access to Your Trials
Logging In to the CTRP Accrual Site
Browser Support
This version of the application supports Firefox 14.0.1, and Internet Explorer 8. Although tested
on these browsers alone, CTRP applications should work with all popular browsers. However, if
you use another browser to access CTRP applications, you may experience problems.
About CTRP Subject Accrual
About CTRP Subject Accrual
The CTRP Subject Accrual site provides authorized members of the cancer research community with access to
cancer clinical trials registered with the CTRP (Clinical Trials Reporting Program) for the purpose of reporting
accrual data for clinical studies. This release of the application enables users to enter patient (study subject)
demographic data for Complete trials and patient accrual counts for Abbreviated trials that have been abstracted
(i.e., have reached the Abstracted status). These trials are categorized as follows:
Complete. Trials in this category include the following types of interventional trials:
National. National Cooperative Group Trials. These trials are conducted by the following cooperative
groups:
American College of Radiology Imaging Network
American College of Surgeons Oncology Group
Cancer and Leukemia Group B
Children’s Oncology Group
Eastern Cooperative Oncology Group
European Organization for Research and Treatment of Cancer
Gynecologic Oncology Group
National Cancer Institute of Canada, Clinical Trials Group
National Surgical Adjuvant Breast and Bowel Project
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Southwest Oncology Group
Externally Peer-Reviewed. R01s and P01s or other trial mechanisms funded by NIH or supported by
other peer-reviewed funding organizations.
In-house trials authored or co-authored by cancer center investigators and undergoing scientific
peer-review solely by the Protocol Review and Monitoring System of the Center. The center
investigator should have primary responsibility for conceptualizing, designing and implementing the
trial and reporting results. It is acceptable for industry and other entities to provide some support (e.g.,
drug, devices, other funding) but the trial should clearly be the intellectual product of the center
investigator.
Abbreviated. Trials in this category are Industrial trials. The design and implementation of these studies is
controlled by the pharmaceutical company.
Who Should Submit Accrual Data?
Patient accrual data should be submitted for interventional studies registered in CTRP. A summary of the type of
data and the organization responsible for submitting the data to CTRP is provided below.
For National Studies
For national studies, CTRP collects patient demographic data for each patient accrued to that particular study. (See
Patient Accrual Data Elements for more information.) The coordinating center is typically responsible for submitting
patient accrual data for all participating sites in the study. Please contact the CTRO if you have questions about who
should be submitting accrual data to CTRP for National studies.
CTEP/DCP PIOs transfer most, if not all, accrual data for National trials to CTRP. Center accrual
submitters who want to submit accrual data for a National trial should contact the CTRO first at n
[email protected] to verify that the accrual should be reported by the Center, and not by CTEP
or DCP.
For Institutional and Externally Peer-Reviewed Studies
For institutional and peer-reviewed studies, CTRP collects patient demographic data for each patient accrued to that
particular study. (See Patient Accrual Data Elements for more information.) The lead organization assigned to a
study is typically responsible for submitting patient accrual data for all participating sites in the study.
For Abbreviated Studies
For industrial studies, only a total count of patients accrued per participating site is required. The organizations
responsible for submitting this data are the participating sites associated with the particular study in CTRP. Each
participating site will submit their own patient accrual data, which will consist of only the total number of patients
accrued at that particular site for that particular study.
Subject Accrual Reporting Methods
CTRP provides three methods for reporting accrual data:
1. CTRP Application User Interface – Manual data entry. The user can log into the CTRP system using a
web browser and enter accrual data for studies to which the user has access. For Abbreviated studies, the
user can enter accrual count of the participating site they are affiliated with by entering the total number of
subjects accrued to date. For Complete studies, the user can enter each patient, including the relevant
demographic data, via the user interface.
2. CTRP Application User Interface – Batch file. This method allows the user to submit patient accrual data in
the form of text files that contain all the relevant accrual information for a particular study. The user can log
into the CTRP accrual application using a web browser, select the batch file that contains the accrual data,
and upload it for processing by the CTRP application.
3. CTRP Trial Registration Service – System-to-System Integration. This method enables vendors, cancer
centers, and other stakeholders to report accrual data using the CTRP Subject Accrual web service. Refer to
the Subject Accrual Service Documentation for further information.
This User's Guide primarily covers methods 1 and 2.
How Often Should Patient Accrual Data be Submitted?
Patient accrual data should be submitted to CTRP on a quarterly basis once accrual has started for a particular
study. CTRP will follow the same schedule that most centers are already using for submission of accrual data to the
NCI CTEP's Clinical Update Data System (CDUS).
Cutoff Dates for Data Collection:
September 30
December 31
March 31
June 30
Deadlines for Reporting to CTRP:
Submission of accrual data to CTRP should be completed each quarter as soon after the data collection cutoff date
as possible, but no later than 30 days after the cutoff date.
Related Topics
Requesting an Accrual Site Account
Logging In to the CTRP Accrual Site
What's New in this Release of CTRP Subject Accrual
What's New in this Release of CTRP Subject Accrual
This version of the CTRP Subject Accrual application has the following new features and improvements:
Batch Submissions
Batch file submissions no longer replace 1 existing subject accrual records. Instead, each subsequent
submission is now treated as an update to existing data or as an addition of new subjects to the study.
Processing capability improvements. The system now is able to process batch files with up to 50,000
records.
During processing, CTRP now considers two additional fields (Change Code and Registering Group
Code) in a batch file. Providing values for these two fields remains optional.
Getting Help
Now you can hover your cursor over fields in the application to see instructions related to it.
The online Help for the application now directs you to the instructions that apply to the page you are
on.
Deleting Study Subject Records
You can delete an existing patient in CTRP only from the Subject Accrual application's Search Study
Subject page.
Viewing Prior Submissions
You now have the option to view all prior accrual submissions via the Subject Accrual application.
The prior submissions list displays the date of submission, name of submitter, link to the batch file, and
the mechanism used for submission (i.e., the Subject Accrual web application's graphical user
interface (GUI), batch upload, or the Accrual service).
Managing User Access to the Subject Accrual Application
Organization's site administrators can now assign or un-assign their registered users access to the
Subject Accrual application via a new feature in the NCI CTRP Registration site.
null
Obtaining a CTRP User Account
Obtaining a CTRP User Account
In order to use the CTRP Accrual application, you must have a CTRP User Account. There are two ways to register
for a CTRP account, as follows:
Via your email address. If you are a new user and you do not have an NCI account, you can request one via
your email address using the CTRP Registration account creation feature.
Via your NCI credentials. If you are a new user and you have an NCI account, create a CTRP account via
your NCI credential using the CTRP Registration account feature.
Once you have obtained a CTRP User Account, request authorization to access your trials. See Requesting Access
to Your Trials for instructions.
Requesting Access to Your Trials
Requesting Access to Your Trials
In order to view and submit accrual data for your trials, you must be a registered CTRP user. Additionally, you must
request access to your trials.
If you do not have a CTRP user account, register for a CTRP account via the CTRP Registration
account feature. For instructions, see Obtaining a CTRP User Account.
How to Request Access to Your Trials
Contact your organization's site administrator to request accrual access for your studies. For instructions on how a
Site Administrator can manage access to studies in Accruals, see the section on Managing Access to Subject
Accruals in the CTRP Registration Site User's Guide.
Logging In to the CTRP Accrual Site
Logging In to the CTRP Accrual Site
Once you have created a CTRP user account, and have been granted accrual access to at least one study, you can
log in to the CTRP Accrual Site and search for clinical trials to submit accrual data.
Gather all the protocol data you need before you begin
The system locks you out if it detects 90 minutes of in-activity. The system also locks you out
after three unsuccessful attempts to log in within 24 hours. In the event that you cannot
remember your password, or have been locked out of your account, contact Application Support.
How to Log In to the CTRP Accrual Site
1. Navigate to the NCI CTRP Accruals home page at http://trials.nci.nih.gov/accrual.
2. On the Home page, click the Log In button on the right side of the banner.
The Login page appears.
3. Enter your NIH/NCI username and password in the fields provided. If you do not have a registered username
and password, see Obtaining a CTRP User Account.
If you have forgotten your password, see the instructions in Changing Your CTRP User Password.
4. Click Log In.
5. After you have read the public reporting burden notice, click Accept.
Related Topics
Managing Your User Account Profile
Obtaining a CTRP User Account
2 - Searching for, and Selecting Your Trials
2 - Searching for, and Selecting Your Trials
This section describes how to use the CTRP Accrual site to search for and select the trials for which you want to
provide new or updated accrual data.
This section includes the following topics:
Searching for Trials in Accrual
Selecting Listed Trials in Accrual
Searching for Trials in Accrual
Searching for Trials in Accrual
The list of trials to which you have been granted access is displayed automatically when you log in to the CTRP
Accrual site. For information on navigating and working with lists of trials, see Navigating Search Results Lists.
Accessing your trials
If you do not see any studies listed when you log in, you may not have been granted access to
submit accrual data for any trials yet. Be sure to request access from your organization's
administrator as explained in Requesting Access to Your Trials.
How to Search For Trials
1. On the navigation pane on the left side of the page, click Trial Search.
The Trial Search page appears.
Search Page-Trial Search Section
2. On the Trial Search page, type the NCI Trial Number, NCT Number, or Official Title in the fields provided,
then click Search.
You can search for a trial by one or more criteria, or you can list all trials to which you
have been granted access by leaving all of the search criteria fields blank. If you search
by the Official Title, use keywords and wildcards rather than phrases or the entire title.
Doing so minimizes the potential for excluding any titles with misspellings or slightly
different phrasing from the search results . For example a Phase II trial may have been
recorded as a Phase 2 trial.
The Search Trials page refreshes and displays the trial(s) you searched for.
Trial Search Page
Each trial is listed by NCI trial identifier, official title and current trial status. Trial statuses are defined in the
table below.
In Review - Trial is currently under IRB review.
Withdrawn - Trial has been withdrawn from development and review prior to enrollment of the first
participant.
Approved - Trial has been approved, but is not yet recruiting or enrolling participants.
Active - Trial is open for accrual and enrollment.
Enrolling by Invitation - Participants are being (or will be) selected from a predetermined population.
Temporarily Closed to Accrual - Participant recruitment or enrollment has been halted prematurely
but may resume. Participants already on trial continue to receive intervention.
Temporarily Closed to Accrual and Intervention - Participant recruitment or enrollment has been
halted prematurely but may resume. Participants already on trial do not receive intervention.
Closed to Accrual - Trial has been closed to participant accrual, but trial is ongoing (i.e., participants
continue to receive treatment and/or examination).
Closed to Accrual and Intervention - Trial has been closed to participant accrual. Participants
already on trial do not receive treatment, but continue to be monitored for endpoints such as long-term
survival.
Administratively Complete - Participant recruitment or enrollment has been halted prematurely (for
example, due to poor accrual, insufficient drug supply, IND closure, etc.), and will not resume.
Participants already on the the trial do not receive further treatment or examination.
Complete - Trial has been closed to accrual and follow-up. Participant treatment/intervention has been
completed and participants are no longer monitored for trial endpoints (i.e., last patient's visit has
occurred). The trial has met its objectives.
3. To view a given trial, click its corresponding NCI Trial Identifier link.
For Abbreviated trials, the page displays the number of study subjects currently enrolled for each of the
participating sites, and the navigation menu changes to Record Accrual Account. See Working with
Abbreviated Trial Accruals.
For Complete trials, the page displays a list of study subjects currently enrolled, and the navigation menu
changes to Study Subject Search. See Working with Complete Trial Accruals.
Viewing Trial Details
To view details for a given clinical trial record, click its associated NCI Trial Identifier link. See Selecting Listed
Trials in Accrual.
Selecting Listed Trials in Accrual
Selecting Listed Trials in Accrual
The CTRP Accrual site displays the Trial Search (top) and the List of Trials (bottom) sections on the first page
automatically after you have logged in and accepted the notification regarding public reporting burden.
The List of Trials page displays the trials to which you have been granted access.
List of Accessible Trials
You can sort the list of trials by clicking a column heading. To reverse the sort order, click the
column heading again.
How to Select Trials on the List of Trials Page
1. Navigate to the trial you want to work with by following the instructions in Navigating Trial Lists.
2. To view a given trial, click its corresponding NCI Trial Identifier link.
Related Topics
Working with Complete Trial Accruals
Working with Abbreviated Trial Accruals
Searching for Trials
Viewing Trial Details
3 - Working with Complete Trial Accruals
3 - Working with Complete Trial Accruals
This section describes how to search for, add, update, and delete study subjects associated with Complete clinical
trials. For information about Industrial trials, see Working With Abbreviated Trial Accruals.
This section includes the following topics:
Adding Study Subjects
Searching for Study Subjects
Reviewing Study Subject Records
Updating Study Subject Records
Deleting Study Subject Records
Adding Study Subjects
Adding Study Subjects
You can add one or more study subject accrual records for any trial to which you have been granted access 1 . See
Requesting Access to Your Trials.
Study subject records include demographic data as well as the disease name. You are required to complete all
fields marked with an asterisk (*).
How to Add Study Subject Records
1. Select the trial you want to work with by following instructions in Selecting Listed Trials or Searching for Trials
in Accrual, by clicking the corresponding NCI Trial Identifier link.
2. If the Search Study Subject/List of Study Subjects page is not already displayed, on the navigation pane,
click Study Subject Search.
The Search Study Subject/List of Study Subjects is displayed.
Search Study Subject/List of Study Subjects
3. At the bottom of the Search Study Subject section, click Add New Study Subject.
The Add Study Subject page appears.
3.
Add Study Subject page
4. Enter the appropriate demographic information in the text fields and Select from drop-down lists. Fields are
described in the following table. Fields marked with an asterisk are required.
Descriptions and instructions for study subject demographic data fields
Study Subject Information
Instruction/Description
Study Subject ID*
Type the unique Patient ID as per the lead
organization or the study site where the subject is
registered.
Study Subject Birth Date*
Type the subject's month and year of birth in the
format MM/YYYY.
Study Subject Gender*
Select the subject’s gender. If gender information is
not available, select Unknown.
Study Subject Race*
Select one or more values for race.
To select multiple races, select
one race, and then press and
hold the CTRL key as you select
the other(s).
Study Subject Ethnicity*
Select a value for ethnicity.
Study Subject Country*
Select the subject’s country of origin.
Study Subject Zip Code
Type the subject’s Zip Code if known. This field is
mandatory if the country of origin is United States.
Registration Date*
Enter the date that the subject was registered for
the trial. See Selecting and Entering Dates
Study Subject Method of Payment
For United States study subjects only, select the
appropriate payment method.
Disease*
Click Look Up, and follow the instructions in Search
ing for Diseases.
Participating Site*
Select the appropriate site from the drop-down list.
5. Click Save.
The study subject record appears in the List of Study Subjects.
null
You can submit accrual data to the NCI CTEP's Clinical Update Data System (CDUS) on a
quarterly basis (i.e., December 31, March 31, June 30) up to 30 days following the end of the
quarter.
For complete trials, lead organizations report all subjects accrued for the trial (both in the lead
organization and in all participating sites). For abbreviated trials, each participating site reports
the number of its own accruals (accrual count) only.
Related Topics
Uploading Accrual Data Files
Searching for Diseases
Searching for Study Subjects
Updating Study Subject Records
Deleting Study Subject Records
Searching for Diseases
Searching for Diseases
How to Search for Diseases
1. Navigate to the trial you want to work with by following the instructions in Selecting Listed Trials or Searching
for Trials in Accrual, and then click the corresponding NCI Trial Identifier link.
2. At the bottom of the Search Study Subject section, click Add New Study Subject.
The Add Study Subject page appears.
3. To assign a disease to the study subject, next to the Disease field, click Look Up.
The Search Diseases window appears.
Search Diseases Window
4. In the Disease Name field, type part or all of the disease/condition being studied. To include SDC (CTEP's
Simplified Disease Classification) disease names in your search, select the Display SDC Disease Terms ch
eck box.
Search tips
Type as many letters of the disease/condition name as possible to reduce the number of
search results. The system adds wildcards on both sides of
the search string (the series of letters you type) for you implicitly. You can type wildcard
symbols (%) between characters of the string as necessary.
5. Click Search.
The system searches for the disease/condition in the database, and returns a list of results.
Search Disease Window
6. Scroll through the list (if necessary) to locate the disease/condition being studied, and click Select.
The system populates the Disease field for you.
Related Topics
Reviewing Study Subject Records
Searching for Study Subjects
Updating Study Subject Records
Deleting Study Subject Records
Searching for Study Subjects
Searching for Study Subjects
You can search for a particular study subject record using any combination of the following three criteria:
Study Subject ID
Participating Site
Birth Date
You must select a trial before you can search for study subjects. For instructions, see Searching
for, and Selecting Your Trials.
How to Search for Study Subjects
1. If the Search Study Subject/List of Study Subjects page is not already displayed, on the navigation pane,
click Study Subject Search.
The Search Study Subject page appears.
Search Study Subject Page
2. Type or select your search criteria from one or more of the fields provided.
You can list all study subjects
You can search for a trial by one or more criteria, or you can list all subjects associated
with trials to which you have been granted access by leaving all of the search criteria
fields blank.
3. ClickSearch.
Your search results are displayed in the List of Study Subjects section of the page. The list is sorted by Study
Subject ID, and includes the following information:
Study Subject ID
Date on which the subject was registered at a given participating site
The Participating Site where this subject is registered
Date/Time of when this record was updated in CTRP
Search Study Subject Page - Search Result
Related Topics
Reviewing Study Subject Records
Adding Study Subjects
Updating Study Subject Records
Deleting Study Subject Records
Reviewing Study Subject Records
Reviewing Study Subject Records
CTRP Accrual site enables you to review the collection of non PII (Personally Identifiable Information) study subject
data associated with a particular non-industrial trial registered with the CTRP.
How to Review Study Subject Records
1. Navigate to the appropriate trial and click the NCI Trial Identifier. For instructions on locating a particular
trial, see Searching for Trials in Accrual.
The Accrual Submissions page displays any accrual records that may have been submitted previously.
List of Study Subject Records
2. Click the Study Subject ID of interest.
The Study Subject page displays the study subject's demographic details recorded to date as well as
information about the record itself.
Study Subject Page
3. To return to the accrual record, click Back.
Related Topics
Searching for Study Subjects
Adding Study Subjects
Updating Study Subject Records
Deleting Study Subject Records
Updating Study Subject Records
Updating Study Subject Records
You can update study subject records for Complete trials as necessary.
How to Update Study Subject Records
1. Navigate to the trial you want to work with by following the instructions in Selecting Listed Trials in Accrual or
Searching for Trials in Accrual, and then click the corresponding NCI Trial Identifier link.
2. If the Search Study Subject/List of Study Subjects page is not already displayed, on the navigation pane,
click Study Subject Search.
The Search Study Subject/List of Study Subjects is displayed.
Study Subject Records - Update Icon
3. In the list of study subjects, click the Update icon.
The Update Study Subject page displays the study subject’s current information.
Update Study Page
4. Make any changes as appropriate, and then click Save.
Related Topics
Reviewing Study Subject Records
Searching for Study Subjects
Deleting Study Subject Records
Deleting Study Subject Records
Deleting Study Subject Records
If a subject has been enrolled to an incorrect study or added due to an administrative error, you have the option to
delete the subject from that study.
How to Delete Subject Records
1. Navigate to the trial you want to work with by following the instructions in Selecting Listed Trials or Searching
for Trials, and then click the corresponding NCI Trial Identifier link.
2. If the Search Study Subject/List of Study Subjects page is not already displayed, on the navigation pane,
click Study Subject Search.
The Search Study Subject/List of Study Subjects is displayed.
Study Subject Records - Delete Icon
3. In the list of study subjects, click the Delete icon.
Be sure to select the Delete icon for the proper record. Once you have deleted a study
subject record, there is no way to retrieve it. However, you can add it back to the trial later
The Subject Delete Reason window appears.
Subject Delete Reason
4. Select the reason for deleting this subject, either Enrolled in Incorrect Study or Other Administrative Error
, and then click OK.
You can cancel the deletion process
If you decide not to delete the subject record, click Cancel.
Related Topics
Reviewing Study Subject Records
Searching for Study Subjects
Updating Study Subject Records
Adding Study Subjects
4 - Working with Abbreviated Trial Accruals
4 - Working with Abbreviated Trial Accruals
This section describes how to submit and update the total number of accruals (accrual count) associated with an
Abbreviated clinical trial. For instructions for submitting accrual data for Complete trials, see Working with Complete
Trial Accruals.
Because pharmaceutical companies do not enter their data into CTRP, each participating site on an Abbreviated
study must enter its own accrual count into CTRP. For Abbreviated studies, the lead organization is the
pharmaceutical company running the trial.
Patient demographic data.
Abbreviated study records include the total number (count) of patients accrued per site on a
given trial; full patient demographic data is not recorded.
Submitting Participating Site Subject Accrual Counts
Each participating site can submit/update the number of patients accrued to date per study.
How to Submit Participating Site Subject Accrual Counts
1. Locate the trial of interest by following the instructions in Selecting Listed Trials in Accrual or Searching for
Trials in Accrual.
2. Click the trial's NCI Trial Identifier.
The Participating Site Subject Accrual Count page appears, and the navigation pane displays the Record
Accrual Information menu.
Site Subject Accrual Count Page
3. In the Number of Subjects Enrolled field, enter the number of subjects currently enrolled in studies at your
site.
4. In the Save column, select the check box for the record you want to update, and then click Save.
A message at the top of the table indicates that the record has been updated successfully.
5 - Submitting Accrual Data Batch Files
5 - Submitting Accrual Data Batch Files
This section provides instructions for uploading batch files via the CTRP Accrual application. It also provides
instructions for resolving any errors that may have occurred during the import process.
The batch upload feature enables you to submit accrual data for multiple subjects and one or more trials at a time
rather than having to enter data for each subject/study individually via the CTRP Accrual web application.
You can upload accrual data files singly as plain text files or in multiple text files that have been
compressed into a Zip file. See Preparing CTRP Subject Accrual Batch Files for detailed
instructions.
This section contains the following topics:
Preparing CTRP Subject Accrual Batch Files
Uploading CTRP Subject Accrual Batch Data Files
Related Topic
Subject Accrual Service Documentation
Preparing CTRP Subject Accrual Batch Files
Preparing CTRP Subject Accrual Batch Files
When a trial has accrued many subjects, rather than entering the data subject-by-subject via UI, you can upload all
study subject data into CTRP using a batch file upload. The information that follows provides all the details you need
to create a CTRP Accruals Batch file.
Use the Batch File Utility as a guide
If you are new to the batch file creation process, you can use the Batch File Utility at https://ncisv
n.nci.nih.gov/svn/coppa/trunk/documents/user_guides/accrual_application_guide/Accrual%20Bat
ch%20File%20Tool.xlsm to get you started. With it you can produce properly-formatted batch
files that you can upload in the Accrual application.
When you create a batch file, ensure that each data element conforms to the requirements.
List each data element in its appropriate position in a given row
Use the correct character cases (CAPITAL vs. lower case letters)
Use the correct character lengths (number of characters allowed in a single field)
After you have prepared a batch file, you can upload it to CTRP. For instructions on submitting batch files, see Uplo
ading CTRP Subject Accrual Batch Data Files.
Key Facts about CTRP Accrual Batch Files
This section provides a summary of key facts about preparing CTRP Accrual batch files.
The CTRP Accrual Batch File format is based on the CTEP Clinical Data Update System (CDUS) file format.
You can obtain a copy of the CDUS Instructions and Guidelines, which explains the CDUS file format in great
detail, at the CTEP web site at http://ctep.cancer.gov/protocolDevelopment/electronic_applications/cdus.htm.
Although the CTRP accrual batch file format is CDUS-compatible, CTRP captures a subset of all the CDUS
required data elements. Appendix C provides a list of all the CDUS fields with a note next to each field
indicating whether CTRP captures it.
Different data elements are required and expected when submitting accrual data to CTRP for Complete trials
(National, Externally Peer Reviewed, and Institutional) than for Abbreviated Trials (Industrial). Instructions are
provided below for preparing batch files for both Complete and Abbreviated Trials.
A CTRP accrual batch file is a TXT (.txt) file with fields delimited (separated) by commas.
Each CTRP batch text file contains accrual data for a single trial.
You can compress one or more CTRP accrual batch text files into a single Zip file and then upload this Zip file
into CTRP. CTRP will unzip the file and process each TXT file. Your Zip file can include batch files for both
Complete and Abbreviated Trials.
Each batch submission uploaded into CTRP is treated as an update to existing records or as an addition of
new ones.
If you upload data to a trial that already has accrual data, the batch file is considered an update.
The system compares your new data to existing data using identifiers. When the identifiers
match, existing data in CTRP is updated. When there are no matching identifiers, data is added
to the existing study. For Abbreviated trials, the system updates the accrual counts.
An Introduction to Batch Files
This section provides general background information about batch file structure. Subsequent
sections provide specific details about the CTRP Subject Accrual Batch file structure.
Each line of text in a batch file corresponds to one record that consists of various required or optional data elements.
Each data element is separated by a comma.
Traditional Table Structure
Column 1
Column 2
Column 3
Column 4
Row 1-Field 1
Row 1-Field 2
Row 1-Field 3
Row 1-Field 4
Row 2-Field 1
Row 2-Field 2
Row 2-Field 3
Row 2-Field 4
Corresponding Comma-Delimited Structure
Comma-Delimited Structure
Field 1,Field 2,Field 3,Field 4
Field 1,Field 2,Field 3,Field 4
The number of fields in a row is dictated by the number of fields required in a CTRP or CDUS record. The Complete
Trial Table and Abbreviated Trial Table indicate how many fields are required in each CDUS record, and how many
are required in a CTRP record. The batch file must contain values or palce holders (commas) equal to the number of
required fields corresponding to the CDUS format. Leave fields that are not required by CTRP blank, but keep the
commas to indicate the "missing" field values.
For example, if a CDUS record requires six fields, as shown below, and the CTRP record requires only three, use
commas to indicate the "missing" values.
Fields Required for CDUS Records
CDUS Field 1,CDUS Field 2,CDUS Field 3,CDUS Field 4,CDUS Field 5,CDUS Field 6
Fields Required for CTRP Batch File
CTRP Field 1,CTRP Field 2,,,,CTRP Field 6
In a traditional table grid structure, the column headings indicate the order in which the field values occur. In CTRP
batch files, the column heading is implicit, and the field order is sequential from left to right, beginning at Field 1.
Traditional Table Structure
Column 1
Column 2
Column 3
Column 4
Row 1-Field 1
Row 1-Field 2
Row 1-Field 3
Row 1-Field 4
Comma-Delimited Structure
Field #1,Field #2,Field #3,Field #4
The first field in each record is reserved for the table name, which is always in CAPITAL letters. The exact field
number for each data element is provided in the Complete Trial Record Data Field Requirements and Abbreviated
Trial Record Data Field Requirements tables.
Example - Using Automobiles Instead of Patients
Suppose CDUS stores information about cars (rather than accrued patients) in its database in a table called
AUTOMOBILES.
In this example, CDUS records each of the following six data elements:
Table Name
VIN (Vehicle Identification Number)
Make
Model
Color
Year
These data elements are arranged in the following sequence:
Table Name
VIN
Make
Model
The corresponding comma-delimited sequence is as follows:
Color
Year
Comma-Delimited Data Elements
,,,,,
A traditional table structure for these CDUS data elements and their values are shown below.
Table Name
VIN
Make
Model
Color
Year
AUTOMOBILE
ABC-123456
Ford
Mustang
Black
1965
The corresponding comma-delimited structure is as follows:
Comma-Delimited Data Values
AUTOMOBILE,ABC-123456,Ford,Mustang,Black,1965
And, to extend this example, suppose that CTRP does not capture the Model nor Color of the car. In this case, the
final record in the CTRP batch file would be as follows:
Comma-Delimited CTRP Data Values
AUTOMOBILE,ABC-123456,Ford,,,1965
File Naming Conventions
The CTRP Accrual Batch File is a TEXT file with fields delimited (separated) by commas. The file can have any
name. However, we recommend using the following file naming conventions:
NCI Protocol Number_date.txt (with the date format: YYYYMMDD)
Example File Name
NCI-2012-00XXX_20090430.txt
The total number of characters in the file name including the file path must be less than or equal
to 260. Use the file extensions .txt (for a single file) or .zip for compressed .txt files.
Batch File Data for Complete Trials
Complete Trials in CTRP are those with the Summary 4 trial submission categories of National, Externally Peer
Reviewed, or Institutional.
The CTRP Accrual Batch File conforms to the CDUS file specification, but it only uses a limited number of fields
from that file. Data in the rest of the fields is ignored, but the place holders (commas) must still be present in the
data file, whether empty or filled.
Complete Trial Tables
Tables identify the record type for each record. The CTRP uses the following tables for complete trials.
Table Name
Number of CDUS Fields
(Excluding the Table
Name)
Number of Fields Used
by CTRP
Purpose
(Excluding the Table
Name)
COLLECTIONS
10
2
Identifies the study for this
data file
PATIENTS
23
12
Subject-specific accrual
data
PATIENT_RACES
3
3
Subject's Race
See Appendix C for a list of all the CDUS fields for these tables.
Complete Trial Data Element and Field Formats
Each row in a batch file is associated with a single record in the database. The first field in each line identifies the
name of the table that a record belongs to. Subsequent fields contain different data element values for the same
table. The number of fields required in each record, and the values they must contain, are provided in the Complete
Trial Record Data Field Requirements table. Because many more elements are required in CDUS records than in
CTRP records, many fields in your batch file will be null (contain no field values at all). In these cases, use a comma
to indicate a field for which there is no datum.
If a comma is part of the value, enclose the fields in double quotes. Otherwise the use of double
quotes is optional.
Examples of Valid Data Formats
"COLLECTIONS","NCI-2009-012345",,,,,,,,,"1"
-ORCOLLECTIONS,"NCI-2009-012345",,,,,,,,,1
-ORCOLLECTIONS,NCI-2009-012345,,,,,,,,,1
Complete Trial Data Record Formats
Each line of the data file contains one record, is prefixed by the table name, and is comma delimited.
Important!
Use blank fields for those fields that are included in the CDUS standard but not used by the
CTRP.
Valid Record Formats and Field Sequence
COLLECTIONS,,,,,,,,,,
PATIENTS,,,,,,,,,,,,,,,,,,,,,,,
PATIENT_RACES,,,
The following is an example batch file for a study that has three study subjects, and one race per subject using
CTRP accepted valid values. In the example below "Male", for example, is used instead of a CDUS accepted
numeric value of "1".
Example Batch File
COLLECTIONS,NCI-2011-03861,,,,,,,,,1
PATIENTS,NCI-2011-03861,873222899999999,84124,,196311,Male,Unknown,Private
Insurance,20060809,CALGB,149280,,,,,,,,,,238.7,,
PATIENTS,NCI-2011-03861,8732228,84124,,196311,Male,Unknown,Private
Insurance,20060809,CALGB,149280,,,,,,,,,,238.7,,
PATIENTS,NCI-2011-03861,1,84124,,196311,Male,Unknown,Private
Insurance,20060809,CALGB,149280,,,,,,,,,,185.0,,
PATIENT_RACES,NCI-2011-03861,8732228,White
PATIENT_RACES, NCI-2011-03861,873222899999999,Asian
PATIENT_RACES,NCI-2011-03861,1,White
The following is another example batch file, accepted by CTRP, for the same study but using CDUS accepted
numeric codes instead of the text values used in the example above .
Example Batch File
COLLECTIONS,NCI-2011-03861,,,,,,,,,1
PATIENTS,NCI-2011-03861,873222899999999,84124,,196311,1,9,1,20060809,CALGB,149280,,,
,,,,,,,238.7,,
PATIENTS,NCI-2011-03861,8732228,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,2
38.7,,
PATIENTS,NCI-2011-03861,1,84124,,196311,1,9,1,20060809,CALGB,149280,,,,,,,,,,185.0,,
PATIENT_RACES,NCI-2011-03861,8732228,01
PATIENT_RACES, NCI-2011-03861,873222899999999,05
PATIENT_RACES,NCI-2011-03861,1,01
Complete Trial Record Data Field Requirements
The following table contains detailed information about each of the data elements included in the Batch Upload file.
The CDUS Accepted Values are provided to show differences in case your system is already producing the CDUS
file. In most cases, both CTRP and CDUS values are accepted.
Subject Accrual Data Elements table with CTRP-accepted values
Subject
Accrual Data
Element
Name
Mandatory=
M;
Optional=O
Conditional
=C
Definition
CTRP
Accepted
Values
Information
Model Class
/ Diagram
Mapping
Comments/C
onditions
Study
Identifier
M
Unique
identifier
assigned to
the study
NCI, CTEP,
or DCP
Identifier
Study
Protocol /
assignedIden
tfier
--
Study Subject
Identifier
M
Unique
identifier
(numeric or
alphanumeric
) assigned to
subjects in a
study
Any numeric
or
alphanumeric
value
assigned to a
study subject
Study Subject
/ identifier
--
ZIP Code
C
String of
characters
used to
identify the
five-digit
Zone
Improvement
Plan (ZIP)
code that
represents
the
geographic
segment that
is a subunit of
the ZIP code,
assigned by
the U.S.
Postal
Service to a
geographic
location to
facilitate mail
delivery.
5 digit
numeric ZIP
code
Patient /
postalAddres
s
Mandatory if
U.S.
Country of
Residence
C
Name of a
country from
which a
person or
their
biological
family had
previous
residence or
past
ancestors.
2-letter ISO
Country
Codes
Patient /
postalAddres
s
Mandatory if
not U.S.
Patient’s Date
of Birth
M
The month
and year on
which the
person was
born
YYYYMM
Patient /
birthDate
Year and
Month are
mandatory
Gender of a
Person
M
Text
designations
that identify
gender.
Gender is
described as
the
assemblage
of properties
that
distinguish
people on the
basis of their
societal roles
Male
Female
Unspecified
Unknown
Patient /
sexCode
Identification
of gender is
based upon
self-report
and may
come from a
form,
questionnaire
, interview,
etc.
Ethnicity
M
Text for
reporting
information
about
ethnicity
based on the
Office of
Management
and Budget
(OMB)
categories
Hispanic or
Latino
Not
Hispanic or
Latino
Not
Reported
Unknown
Patient /
ethnicGroupC
ode
--
Payment
Method
O
Term for an
entity,
organization,
government,
corporation,
health plan
sponsor, or
any other
financial
agent who
pays a
healthcare
provider for
the
healthcare
service
rendered to a
person or
reimburses
the cost of
the
healthcare
service
Subject
Registration
Date
M
Date the
subject was
registered to
the study
Registering
Group Code
O
Unique CTEP
Group code
assigned to
the group that
originally
registered the
patient for the
study
Private
Insurance
Medicare
Medicare
and Private
Insurance
Medicaid
Medicaid
and
Medicare
Military or
Veterans
Sponsored,
NOS
Military
Sponsored
(Including
CHAMPUS
&
TRICARE)
Veterans
Sponsored
Self-Pay
(No
Insurance)
No Means
of Payment
(No
Insurance)
Managed
Care
State
Supplemen
tal Health
Insurance
Other
Unknown
StudySubject
/
paymentMeth
odCode
--
YYYYMMDD
PerformedSu
bjectMileston
e/
registrationD
ate
--
--
StudySubject
/
registrationGr
oupId
For trials with
Group
participation,
provide CTEP
Group Code,
if available
Study Site
Identifier
M
Unique
identifier (PO
ID) assigned
to the
institution
accruing the
patient to the
study
Subject
Disease
Code
M
Code that
identifies a
disease
CTRP
Person/Orga
nization ID
(PO ID)
CTEP
Simplified
Disease
Code
(SDC)
terms
ICD 9 CM
codes
Study Site /
identifier
--
For SDC
Disease
Code:
StudySubject
/
diease_identif
ier
Disease code
is mandatory
for all trials
except those
managed by
DCP PIO.
For ICD9
Disease
Code:
StudySubject
/
icd9diease_id
entifier
Cancer
specific ICD9
CM disease
codes in the
range 140 to
239.
Information
about these
disease
codes is
available at ht
tp://www.icd9
data.com/201
2/Volume1/14
0-239/default.
htm
Race
M
Text for
reporting
information
about race
based on the
Office of
Management
and Budget
(OMB)
categories
American
Indian or
Alaska
Native
Asian
Black or
African
American
Native
Hawaiian
or Other
Pacific
Islander
Not
Reported
Unknown
White
Patient /
raceCode
--
Change Code
O
Additions or
changes
since the last
report
1
2
NULL
AccrualCollec
tions /
changeCode
1 or NULL =
changes in
the file; CTRP
will process
and save the
submission
2 = no
changes in
the file: CTRP
will not
process the
file, but will
save the
submission
Subject Accrual Data Elements table with CDUS-accepted values
Subject Accrual
Data Element
Name
Mandatory=M;
Optional=O
Conditional = C
Definition
CDUS Accepted
Values
Comments/Conditi
ons
Study Identifier
M
Unique identifier
assigned to the
study
CTEP Identifier
--
Study Subject
Identifier
M
Unique identifier
(numeric or
alphanumeric)
assigned to subjects
in a study
Any numeric or
alphanumeric value
assigned to a study
subject
--
ZIP Code
C
String of characters
used to identify the
five-digit Zone
Improvement Plan
(ZIP) code that
represents the
geographic segment
that is a subunit of
the ZIP code,
assigned by the
U.S. Postal Service
to a geographic
location to facilitate
mail delivery.
5 digit numeric ZIP
code
Mandatory if U.S.
Country of
Residence
C
Name of a country
from which a person
or their biological
family had previous
residence or past
ancestors.
2-letter ISO Country
Codes
Mandatory if not
U.S.
Patient’s Date of
Birth
M
The month and year
on which the person
was born
YYYYMM
Year and Month are
mandatory
Gender of a Person
M
Text designations
that identify gender.
Gender is described
as the assemblage
of properties that
distinguish people
on the basis of their
societal roles
1 = Male
2 = Female
9 = Unknown
Identification of
gender is based
upon self-report and
may come from a
form, questionnaire,
interview, etc.
Ethnicity
M
Text for reporting
information about
ethnicity based on
the Office of
Management and
Budget (OMB)
categories
1 = Hispanic or
Latino
2 = Not Hispanic
or Latino
8 = Not Reported
9 = Unknown
--
Payment Method
O
Term for an entity,
organization,
government,
corporation, health
plan sponsor, or any
other financial agent
who pays a
healthcare provider
for the healthcare
service rendered to
a person or
reimburses the cost
of the healthcare
service
1 = Private
Insurance
2 = Medicare
3 = Medicare and
Private Insurance
4 = Medicaid
5 = Medicaid and
Medicare
6 = Military or
Veterans
Sponsored, Not
Otherwise
Specified (NOS)
6A = Military
Sponsored
(including
CHAMPUS or
TRICARE)
6B = Veterans
Sponsored
7 = Self pay (no
insurance)
8 = No means of
payment (no
insurance)
98 = Other
99 = Unknown
--
Subject Registration
Date
M
Date the subject
was registered to
the study
YYYYMMDD
--
Registering Group
Code
O
Unique CTEP Group
code assigned to
the group that
originally registered
the patient for the
study
--
--
Study Site Identifier
M
Unique identifier
(PO ID) assigned to
the institution
accruing the patient
to the study
CTEP Site ID
--
Subject Disease
Code
M
Code that identifies
a disease
CTEP Simplified
Disease Code
(SDC) terms
ICD 9 CM codes
Disease code is
mandatory for all
trials except those
managed by DCP
PIO.
Cancer specific
ICD9 CM disease
codes in the range
140 to 239.
Information about
these disease codes
is available at http://
www.icd9data.com/
2012/Volume1/140239/default.htm
Race
M
Text for reporting
information about
race based on the
Office of
Management and
Budget (OMB)
categories
Change Code
O
Additions or
changes since the
last report
01 = White
03 = Black or
African American
04 = Native
Hawaiian or Other
Pacific Islander
05 = Asian
06 = American
Indian or Alaska
Native
98 = Not
Reported
99 = Unknown
--
--
--
Complete Trial Record Data Field Formats
The following table lists the data fields by the table in which they are recorded. It also provides the field number (field
position in a row); and the format and character limits for each field.Tables
COLLECTIONS
Field (Field Position in a Row)
Format (Maximum Number of
Characters)
Study Identifier (2)
Text (35)
COLLECTIONS
Change Code (11)
Number (1)
PATIENTS
Study Identifier (2)
Text (35)
PATIENTS
Study Subject Identifier (3)
Text (20)
PATIENTS
ZIP Code (4)
Text (10)
PATIENTS
Country of Residence (5)
Text (2)
PATIENTS
Patient's Date of Birth (6)
Date (YYYYMM)
PATIENTS
Gender of a Person (7)
Text (10)
PATIENTS
Ethnicity (8)
Text (25)
PATIENTS
Payment Method (9)
Text (50)
PATIENTS
Subject Registration Date (10)
Date (YYYYMMDD)
PATIENTS
Registering Group Identifier (11)
Text (25)
PATIENTS
Study Site Identifier (12)
Text (25)
PATIENTS
Subject Disease Code (22)
Number (10)
PATIENT_RACES
Study Identifier (2)
Text (35)
PATIENT_RACES
Study Subject Identifier (3)
Text (20)
PATIENT_RACES
Race (4)
Text (45)
The relation between COLLECTIONS, PATIENTS, and PATIENT_RACES is that a
COLLECTIONS can have multiple PATIENTS, and PATIENTS can have multiple
PATIENT_RACES. These relations are maintained through the use of consistent Study Identifier
and Study Subject Identifier fields.
Using the format table, you can determine that you must enter the Patient's Date of Birth in the sixth position in a
row in the PATIENTS table as YYYYMM. The following diagram contains a typical line of text from a batch file.
Brackets with numbers indicate the field position number.
In the example above, the fifth field position (5) is null (blank) because it (Country of Residence)
is a conditionally required field and in this example is not required.
Batch File Data for Abbreviated Trials
Abbreviated Studies in CTRP are those with the Summary 4 trial submission category of Industrial. The CTRP
require users to submit accrual totals only for these trials. Do not submit subject-specific data. The CTRP Accrual
Batch File uses the same file format as CDUS, but the fields are unique to CTRP.
Abbreviated Trial Tables
Tables identify the record type for each record. CTRP uses the following tables for abbreviated studies.
Table Name
Number of CDUS Fields
(Excluding the Table
Name)
Number of Fields Used
by CTRP
Purpose
(Excluding the Table
Name)
COLLECTIONS
10
1
Identifies the study for this
data file
ACCRUAL_COUNT
0
3
Aggregate accrual data
Abbreviated Trial Data Record Formats
Each line of the data file contains one record, is prefixed by the table name, and is comma delimited.
Use blank fields for those fields that are included in the CDUS standard but not used by the
CTRP.
Valid Record Formats and Field Sequence
COLLECTIONS,,,,,,,,,,
ACCRUAL_COUNT,,,< Study_Site_Accrual_Count>
The following is an example batch file for one study and two study sites.
Example Batch File
COLLECTIONS,NCI-2012-00225,,,,,,,,,
"ACCRUAL_COUNT","NCI-2009-00003","Site 1","10"
"ACCRUAL_COUNT","NCI-2009-00003","Site 2","20"
Abbreviated Trial Record Data Field Requirements
The following table contains detailed information about each of the data elements included in the Batch Upload file
for Abbreviated Trials. The CDUS Accepted Values are provided to show differences in case your system is already
producing the CDUS file.
Subject Accrual Data Elements table with CTRP-accepted values
Subject
Accrual Data
Element
Name
Mandatory=
M;
Optional=O
Conditional
=C
Definition
CTRP
Accepted
Values
Information
Model Class
/ Diagram
Mapping
Study
Identifier
M
Unique
identifier
assigned to
the study
NCI, CTEP,
or DCP
Identifier
Study
Protocol /
assignedIden
tfier
Study Site
Identifier
M
Unique
identifier (PO
ID) assigned
to the
institution
accruing the
patient to the
study
PO ID
Study Site /
identifier
Study Site
Accrual
Count
M
Numeric
count of
subjects
accrued at a
study site to
date
Numeric
Study Site /
subjectAccru
alcount
Subject Accrual Data Elements table with CDUS-accepted values
Subject Accrual Data
Element Name
Mandatory=M;
Optional=O
Conditional = C
Definition
CDUS Accepted Values
Study Identifier
M
Unique identifier assigned
to the study
CTEP Identifier
Study Site Identifier
M
Unique identifier (PO ID)
assigned to the institution
accruing the patient to the
study
CTEP Site ID
Study Site Accrual Count
M
N/A
--
Abbreviated Trial Data Field Requirements
Tables
Field (Field Position in a Row)
Format (Maximum Number of
Characters)
COLLECTIONS
Study Identifier (2)
Text (35)
ACCRUAL_COUNT
Study Identifier (2)
Text (35)
ACCRUAL_COUNT
Study Site Identifier (3)
Text (25)
ACCRUAL_COUNT
Study Site Accrual Count (4)
Text (10)
The COLLECTIONS and ACCRUAL_COUNT tables are linked by consistent Study Identifier and
Study Site Identifier fields. There is no limit to the number of ACCRUAL_COUNT records.
Uploading CTRP Subject Accrual Batch Data Files
Uploading CTRP Subject Accrual Batch Data Files
Once you have created your Accruals Batch Upload file, it can be uploaded via the CTRP Accrual web interface.
Existing accrual data for the study will be updated and any new data you submit will be added.
The batch files you submit do not delete previously accrued patients. Use the Subject Accruals
application user interface to delete accrued subjects as necessary.
This section contains the following topics:
Uploading Accrual Batch Files
Resolving Accrual Batch File Upload Errors
Uploading Accrual Batch Files
Be sure to complete your batch file preparation first
Before you begin, gather all the protocol data you need. See Preparing CTRP Subject Accrual
Batch Files for instructions.
The system logs you out if it detects that you have not used the application for 90 minutes. The
system also logs you out after three unsuccessful attempts to log in within 24 hours. In the event
that you cannot remember your password, contact Application Support at http://ncicb.nci.nih.gov/
support.
How to Upload Accrual Batch Files
1. On the navigation pane, click Batch Upload
The Batch Upload page appears.
Accrual Batch Upload Page
2. Click Browse and select the .txt or .zip file that contains your accrual data.
Click Submit.
Your file is uploaded to the system and processed in the background
When processing has been completed, the system sends you an email message to inform you of the status of your
file(s). It includes the following information:
NCI Identifier
Number of subject accruals that the system imported
Details of any errors that may have occurred during the import process
Once you have uploaded your batch file, the CTRP system continues to update the record status both by email and
the Accrual application. To view the information you uploaded, see Reviewing and Updating Prior Accrual
Submissions.
Resolving Accrual Batch File Upload Errors
If the email notice you received after uploading a batch file indicated that errors occurred during the the import
process, you can use the following steps to correct them before re-submitting your accruals batch file.
How to Resolve Accrual Batch File Upload Errors
1. Go thru the list of errors described in detail in the status email you received for each line in your text file that
caused the error.
2. Correct the errors.
3. Save the file and re-submit.
6 - Working with Prior Accrual Submission Records
6 - Working with Prior Accrual Submission Records
The CTRP system maintains records of all prior accrual submissions on a trial-by-trial basis. Additionally, the system
records the method that was used to submit the information to the CTRP: via the Subject Accrual web application's
graphical user interface (GUI), including single submissions and batch uploads; or the Accrual service.
The Accruals Historical Submissions Page allows you to do the following:
List all of your organization's previous accrual submissions
Limit the list of trials displayed to a particular submission date or a range of dates
Access the accrual records (trial counts and subject details for a given trial, allowing you to modify existing
data and add new accrual records)
Download accrual batch upload TXT files previously submitted
This section contains the following topics:
Accessing Trials with Prior Accruals Records
Reviewing and Updating Prior Accrual Submissions
Downloading Submitted Subject Accrual Files
Accessing Trials with Prior Accruals Records
Accessing Trials with Prior Accruals Records
All trials to which you have been granted permission to submit accruals are listed automatically when you log into
the Accruals application. Optionally, you can limit the list of trials that are displayed to a given date or range of dates.
The following information for each trial is displayed:
Trial ID. The trial identification given to the trial when it was registered with the CTRP
Files Submitted. Links to the following accrual details
Batch file (when applicable)
Trial subjects
Trial counts
Type of Submission. Mechanism used to submit accrual data i.e. via the Subject Accrual web application's
graphical user interface (GUI), batch uploads, or the Accrual service
Date and Time of Submission. Date the accrual record was either added or modified in CTRP
User who Submitted. Name of the Registered CTRP user who submitted the accrual information
Results. Indicates whether or not the submission was processed successfully (Pass), or there were errors in
the submission (Fail). Immediately after submitting new or updated accrual data, the system sends you an
email message, indicating whether the submission passed or failed. If the processing failed, the email
message explains the nature of the errors.
How to Access Trials with Prior Accrual Records
1. On the navigation pane, click Prior Submissions
All of your organization's prior accrual submission records to which you have been granted Accrual access
are listed automatically.
List of Prior Submissions by Trial
2. Optionally, to limit the list of submissions to a date, or range of dates, in the From field, select or enter the
first date of the range or the exact date of the submission you are searching for. In the To field, enter the last
date of the range. Then click Search.
Sorting Prior Submission Records
You can sort the list of prior submissions by column (except for the File Submitted column)
by clicking the column header.
Reviewing and Updating Prior Accrual Submissions
Reviewing and Updating Prior Accrual Submissions
For Complete trials, all subject records that have been previously submitted are displayed, whether a subject record
was added, modified, or deleted.
How to Review and Modify Prior Complete Trial Accrual Submissions
1. On the navigation pane, click Prior Submissions.
2. To access records of all subjects that were submitted for a given trial at a specific date/time, select the Trial
Subjects link for the trial of interest. See Accessing Trials with Prior Accruals Records.
Locating a study subject record
To locate a particular study subject without having to scroll through a long list of records,
use the Search Study Subject feature.
Accrual Study Subject Records
3. To review a subject's demographic and submission data, in the List of Study Subjects, select the Study
Subject ID link.
4. To update a subject's demographic data, click the Update icon (pencil) and then follow the instructions in Upd
ating Study Subject Records.
5. To delete a subject, click the Delete icon (trash can) and then follow the instructions in Deleting Study Subject
Records.
Downloading Submitted Subject Accrual Files
Downloading Submitted Subject Accrual Files
For non-industrial trials, you can download the last accrual submission file (.txt or .zip) that was uploaded via the
Batch Upload feature.
How to Download Submitted Subject Accrual Files
All trials to which you have been granted permission to submit accruals are listed automatically when you log in to
the Accruals application. Optionally, you can limit the list of trials displayed to a given date or range of dates.
1. On the navigation pane, click Prior Submissions
All trials to which you have been granted Accrual access that have existing subject accrual records are listed
automatically.
List of Prior Submissions by Trial
2. Optionally, to limit the list of submissions to a date, or range of dates, in the From field, select or enter the
first date of the range or the exact date of the submission you are searching for. In the To field, enter the last
date of the range. Then click Search.
3. In the File Submitted column for the non-industrial trial of interest, click the link to the file.
The file is downloaded to your computer, where you can view and/or save it.
7 - Managing Your CTRP User Account
7 - Managing Your CTRP User Account
This section provides instructions for modifying your NCI CTRP User account.
Resetting Your Password
Retrieving Your Username
Managing Your User Account Profile
Resetting Your Password
You can reset your NCI password from the NCI Password Station directly, or from the CTRP Registration application
login page.
How to Reset Your NCI Password
Navigate to the NCI Password Station at http://password.nci.nih.gov, or visit NCICB Application Support at htt
p://ncicb.nci.nih.gov/support. Once you have logged in to the NCI Password Station, use the Change
Password feature to create a new password.
- or On the CTRP Registration Login page, click Forgot Your Password?.
A pop-up window provides instructions for resetting your password and a link to the NCI Password Station.
Retrieving Your Username
You can retrieve your username from the CTRP Registration Login page.
How to Retrieve Your Username
1. On the Login Page, click the Forgot Your Username? link.
The Retrieve User Name page is displayed.
2. Enter the email address associated with your account, and click Submit.
The system sends your username to the email address you provided.
Managing Your User Account Profile
You can update your account information after you have registered for an account and have logged in to the CTRP
Registration Site.
How to Edit Your Account Information
1. On the navigation pane on the left side of the page, click My Account.
The My Account page appears, populated with the information you previously supplied for your account.
2. In the Your Account Profile section, make any changes as necessary.
3. Click Submit to save your changes.
8 - Common Tasks and Data Element Formats
8 - Common Tasks and Data Element Formats
This section provides detailed instructions for tasks that are common to many of the procedures included in this
guide.
This section includes the following topics:
Navigating Trial Lists
Entering Phone and Fax Numbers
Selecting and Entering Dates
Navigating Trial Lists
The system lists records satisfying search criteria in Search Results tables. You can navigate through the search
results in several ways, as detailed in the following table.
Methods for Viewing Search Results and Trial Details
To do this...
Do this...
Additional Notes
Sort your results by column
Click the column heading once to
sort the records in ascending order.
Click the column heading again to
reverse the sort order.
-
Move to the next page of results
Click Next or click the next page
number above or below the list of
results.
The Next link is not active on the
last page of results.
Move to the previous page of
results
Click Prev or click the preceding
page number above or below the
list of results.
The Prev link is not active on the
first page of results.
Move to a specific page of results
Click the specific page number
above or below the list of results.
-
Move to the first page of results
Click First above or below the list of
results.
The First link is not active on the
first page of results.
Move to the last page of results
Click Last above or below the list of
results.
The Last link is not active on the
last page of results.
Entering Phone and Fax Numbers
For U.S. and Canadian contacts, type phone and fax numbers in the format xxx-xxx-xxxx. For all others, you can
use spaces or dashes as separators, or no separators at all. Include phone number extensions where applicable.
Selecting and Entering Dates
You can enter a date in the field directly, or select a date from the calendar.
How to Select Dates From a Calendar
1. Click the Calendar icon.
The calendar pop-up window appears.
1.
Calendar Pop-up Window
2. Use the carets (> for month, and >> for year) at the top of the calendar to move forward and backward to the
next/previous month or year.
3. Click the date from the calendar.
4. Click Close.
Selecting a date from the calendar records a date/time stamp.
Appendix A - Accrual Data Elements for Complete Trials
Appendix A - Accrual Data Elements for Complete Trials
The following tables contain detailed information on each of the data elements included in the Batch Upload file. The
first table provides values that are valid for the Batch Upload file. The CDUS Accepted Values in the second table
are provided to show differences in values in case your system is already producing the CDUS file.
Use of CDUS Values
Although you can use CDUS values, they are being phased out in the CTRP. It is best, therefore,
to use the CTRP values listed in the table below.
When you create a batch file, ensure that each data element conforms to the requirements.
List each data element in its appropriate position in a given row
Use the correct character cases (CAPITAL vs. lower case letters)
Use the correct character lengths (number of characters allowed in a single field)
If a comma is part of the value, enclose the field in double quotes. Otherwise the use of
double quotes is optional.
Subject Accrual Data Elements table with CTRP-accepted values
Subject
Accrual Data
Element
Name
Mandatory=
M;
Optional=O
Conditional
=C
Definition
CTRP
Accepted
Values
Information
Model Class
/ Diagram
Mapping
Comments/C
onditions
Study
Identifier
M
Unique
identifier
assigned to
the study
NCI, CTEP,
or DCP
Identifier
Study
Protocol /
assignedIden
tfier
--
Study Subject
Identifier
M
Unique
identifier
(numeric or
alphanumeric
) assigned to
subjects in a
study
Any numeric
or
alphanumeric
value
assigned to a
study subject
Study Subject
/ identifier
--
ZIP Code
C
String of
characters
used to
identify the
five-digit
Zone
Improvement
Plan (ZIP)
code that
represents
the
geographic
segment that
is a subunit of
the ZIP code,
assigned by
the U.S.
Postal
Service to a
geographic
location to
facilitate mail
delivery.
5 digit
numeric ZIP
code
Patient /
postalAddres
s
Mandatory if
U.S.
Country of
Residence
C
Name of a
country from
which a
person or
their
biological
family had
previous
residence or
past
ancestors.
2-letter ISO
Country
Codes
Patient /
postalAddres
s
Mandatory if
not U.S.
Patient’s Date
of Birth
M
The month
and year on
which the
person was
born
Gender of a
Person
M
Text
designations
that identify
gender.
Gender is
described as
the
assemblage
of properties
that
distinguish
people on the
basis of their
societal roles
Ethnicity
M
Text for
reporting
information
about
ethnicity
based on the
Office of
Management
and Budget
(OMB)
categories
YYYYMM
Patient /
birthDate
Year and
Month are
mandatory
Male
Female
Unspecified
Unknown
Patient /
sexCode
Identification
of gender is
based upon
self-report
and may
come from a
form,
questionnaire
, interview,
etc.
Hispanic or
Latino
Not
Hispanic or
Latino
Not
Reported
Unknown
Patient /
ethnicGroupC
ode
--
Payment
Method
O
Term for an
entity,
organization,
government,
corporation,
health plan
sponsor, or
any other
financial
agent who
pays a
healthcare
provider for
the
healthcare
service
rendered to a
person or
reimburses
the cost of
the
healthcare
service
Subject
Registration
Date
M
Date the
subject was
registered to
the study
Registering
Group Code
O
Unique CTEP
Group code
assigned to
the group that
originally
registered the
patient for the
study
Private
Insurance
Medicare
Medicare
and Private
Insurance
Medicaid
Medicaid
and
Medicare
Military or
Veterans
Sponsored,
NOS
Military
Sponsored
(Including
CHAMPUS
&
TRICARE)
Veterans
Sponsored
Self-Pay
(No
Insurance)
No Means
of Payment
(No
Insurance)
Managed
Care
State
Supplemen
tal Health
Insurance
Other
Unknown
StudySubject
/
paymentMeth
odCode
--
YYYYMMDD
PerformedSu
bjectMileston
e/
registrationD
ate
--
--
StudySubject
/
registrationGr
oupId
For trials with
Group
participation,
provide CTEP
Group Code,
if available
Study Site
Identifier
M
Unique
identifier (PO
ID) assigned
to the
institution
accruing the
patient to the
study
Subject
Disease
Code
M
Code that
identifies a
disease
CTRP
Person/Orga
nization ID
(PO ID)
CTEP
Simplified
Disease
Code
(SDC)
terms
ICD 9 CM
codes
Study Site /
identifier
--
For SDC
Disease
Code:
StudySubject
/
diease_identif
ier
Disease code
is mandatory
for all trials
except those
managed by
DCP PIO.
For ICD9
Disease
Code:
StudySubject
/
icd9diease_id
entifier
Cancer
specific ICD9
CM disease
codes in the
range 140 to
239.
Information
about these
disease
codes is
available at ht
tp://www.icd9
data.com/201
2/Volume1/14
0-239/default.
htm
Race
M
Text for
reporting
information
about race
based on the
Office of
Management
and Budget
(OMB)
categories
American
Indian or
Alaska
Native
Asian
Black or
African
American
Native
Hawaiian
or Other
Pacific
Islander
Not
Reported
Unknown
White
Patient /
raceCode
--
Change Code
O
Additions or
changes
since the last
report
1
2
NULL
AccrualCollec
tions /
changeCode
1 or NULL =
changes in
the file; CTRP
will process
and save the
submission
2 = no
changes in
the file: CTRP
will not
process the
file, but will
save the
submission
Subject Accrual Data Elements table with CDUS-accepted values
Subject Accrual
Data Element
Name
Mandatory=M;
Optional=O
Conditional = C
Definition
CDUS Accepted
Values
Comments/Conditi
ons
Study Identifier
M
Unique identifier
assigned to the
study
CTEP Identifier
--
Study Subject
Identifier
M
Unique identifier
(numeric or
alphanumeric)
assigned to subjects
in a study
Any numeric or
alphanumeric value
assigned to a study
subject
--
ZIP Code
C
String of characters
used to identify the
five-digit Zone
Improvement Plan
(ZIP) code that
represents the
geographic segment
that is a subunit of
the ZIP code,
assigned by the
U.S. Postal Service
to a geographic
location to facilitate
mail delivery.
5 digit numeric ZIP
code
Mandatory if U.S.
Country of
Residence
C
Name of a country
from which a person
or their biological
family had previous
residence or past
ancestors.
2-letter ISO Country
Codes
Mandatory if not
U.S.
Patient’s Date of
Birth
M
The month and year
on which the person
was born
YYYYMM
Year and Month are
mandatory
Gender of a Person
M
Text designations
that identify gender.
Gender is described
as the assemblage
of properties that
distinguish people
on the basis of their
societal roles
1 = Male
2 = Female
9 = Unknown
Identification of
gender is based
upon self-report and
may come from a
form, questionnaire,
interview, etc.
Ethnicity
M
Text for reporting
information about
ethnicity based on
the Office of
Management and
Budget (OMB)
categories
1 = Hispanic or
Latino
2 = Not Hispanic
or Latino
8 = Not Reported
9 = Unknown
--
Payment Method
O
Term for an entity,
organization,
government,
corporation, health
plan sponsor, or any
other financial agent
who pays a
healthcare provider
for the healthcare
service rendered to
a person or
reimburses the cost
of the healthcare
service
1 = Private
Insurance
2 = Medicare
3 = Medicare and
Private Insurance
4 = Medicaid
5 = Medicaid and
Medicare
6 = Military or
Veterans
Sponsored, Not
Otherwise
Specified (NOS)
6A = Military
Sponsored
(including
CHAMPUS or
TRICARE)
6B = Veterans
Sponsored
7 = Self pay (no
insurance)
8 = No means of
payment (no
insurance)
98 = Other
99 = Unknown
--
Subject Registration
Date
M
Date the subject
was registered to
the study
YYYYMMDD
--
Registering Group
Code
O
Unique CTEP Group
code assigned to
the group that
originally registered
the patient for the
study
--
--
Study Site Identifier
M
Unique identifier
(PO ID) assigned to
the institution
accruing the patient
to the study
CTEP Site ID
--
Subject Disease
Code
M
Code that identifies
a disease
CTEP Simplified
Disease Code
(SDC) terms
ICD 9 CM codes
Disease code is
mandatory for all
trials except those
managed by DCP
PIO.
Cancer specific
ICD9 CM disease
codes in the range
140 to 239.
Information about
these disease codes
is available at http://
www.icd9data.com/
2012/Volume1/140239/default.htm
Race
M
Text for reporting
information about
race based on the
Office of
Management and
Budget (OMB)
categories
Change Code
O
Additions or
changes since the
last report
01 = White
03 = Black or
African American
04 = Native
Hawaiian or Other
Pacific Islander
05 = Asian
06 = American
Indian or Alaska
Native
98 = Not
Reported
99 = Unknown
--
--
--
Appendix B - Accrual Data Elements for Abbreviated Trials
Appendix B - Accrual Data Elements for Abbreviated Trials
The following tables contain detailed information on each of the data elements included in the Batch Upload file. The
first table provides values that are valid for the Batch Upload file. The CDUS Accepted Values in the second table
are provided to show differences in values in case your system is already producing the CDUS file.
Use of CDUS Values
Although you can use CDUS values, they are being phased out in the CTRP. It is best, therefore,
to use the CTRP values listed in the table below.
When you create a batch file, ensure that each data element conforms to the requirements.
List each data element in its appropriate position in a given row
Use the correct character cases (CAPITAL vs. lower case letters)
Use the correct character lengths (number of characters allowed in a single field)
If a comma is part of the value, enclose the field in double quotes. Otherwise the use of
double quotes is optional.
Subject Accrual Data Elements table with CTRP-accepted values
Subject
Accrual Data
Element
Name
Mandatory=
M;
Optional=O
Conditional
=C
Definition
CTRP
Accepted
Values
Information
Model Class
/ Diagram
Mapping
Study
Identifier
M
Unique
identifier
assigned to
the study
NCI, CTEP,
or DCP
Identifier
Study
Protocol /
assignedIden
tfier
Study Site
Identifier
M
Unique
identifier (PO
ID) assigned
to the
institution
accruing the
patient to the
study
PO ID
Study Site /
identifier
Study Site
Accrual
Count
M
Numeric
count of
subjects
accrued at a
study site to
date
Numeric
Study Site /
subjectAccru
alcount
Subject Accrual Data Elements table with CDUS-accepted values
Subject Accrual Data
Element Name
Mandatory=M;
Optional=O
Conditional = C
Definition
CDUS Accepted Values
Study Identifier
M
Unique identifier assigned
to the study
CTEP Identifier
Study Site Identifier
M
Unique identifier (PO ID)
assigned to the institution
accruing the patient to the
study
CTEP Site ID
Study Site Accrual Count
M
N/A
--
Appendix C - Comparison of CTRP and CDUS Accrual Data
Elements
Appendix C - Comparison of CTRP and CDUS Accrual Data Elements
This appendix lists CDUS (Clinical Data Update System) data elements for Complete trials, and indicates which of
them are captured in CTRP.
COLLECTIONS TABLE
CDUS Fields
Fields Used by CTRP?
Protocol_ID
Yes
Subm_Date
No
CutOff_Date
No
Current_Trial_Status_Code
No
Current_Trial_Status_Date
No
Completer_Name
No
Completer_Phone
No
Completer_FAX
No
Completer_Email
No
Change_Code
Yes
PATIENTS TABLE
CDUS Fields
Fields Used by CTRP?
Protocol_ID
Yes
Patient_ID
Yes
Zip_Code
Yes
Country_Code
Yes
Birth_Date
Yes
Gender_Code
Yes
Ethnicity_Flag
Yes
Method_Of_Payment
Yes
Date_Of_Entry
Yes
Reg_Group_ID
Yes
Reg_Inst_ID
Yes
TX_On_Study
No
Off_TX_Reason
No
Last_TX_Date
No
Off_Study_Reason
No
Off_Study_Date
No
Subgroup_Code
No
Ineligibility_Status
No
Baseline_PS_Code
No
Prior_Chemo_Regs
No
Disease_Code
Yes
Resp_Eval_Status
No
Baseline_Abnormalities_Flag
No
PATIENT_RACES
CDUS Fields
Fields Used by CTRP?
Protocol_ID
Yes
Patient_ID
Yes
Race_Code
Yes
CTRP Subject Accrual Credits
CTRP Subject Accrual Credits
The following technical and domain experts contributed to the development of this document.
This section lists the current members of the CTRP Project Team.
NIH/NCI Project Sponsors
Role
Name
Email
Affiliation
Program Officer
Christo Andonyadis
[email protected]
NCI-CBIIT
Program Officer
Jose Galvez
[email protected]
NCI-CBIIT
Technical Project Management
Role
Name
Email
Affiliation
Technical Project
Manager
Hemant Undale
[email protected]
SAIC-Frederick
Technical Project
Manager
Kathleen McCormick
[email protected]
v
SAIC-Frederick
CTRP Program Management
Role
Name
Email
Affiliation
CTRP Program Director
Gene Kraus
[email protected]
NCI-CCCT
Acting Program Manager
Joe Martucci
[email protected]
Essex Management
Team Lead, Clinical Trials
Informatics
Gisele Sarosy, MD
[email protected]
NCI-CCCT
Clinical Trials Reporting
Office (CTRO) Manager
Kimberly Eckley
[email protected]
om
Lockheed Martin
Software Development Team
Role
Name
Email Address
Affiliation
Project Manager
Edmond Mulaire
[email protected]
SemanticBits
Architect/Developer
Hugh Reinhart
hugh.reinhart@macksonc
onsulting.com
Mackson Consulting
Developer
Denis Krylov
denis.krylov@semanticbit
s.com
SemanticBits
Developer
Monish Dombla
monish.dombla@semanti
cbits.com
SemanticBits
Developer
Reshma Koganti
reshma.koganti@semanti
cbits.com
SemanticBits
Developer
Kalpana Guthikonda
kalpana.guthikonda@mac
ksonconsulting.com
Mackson Consulting
Lead Analyst for PA and
Registry
Charles Yaghmour
[email protected]
v
Samvit Solutions
Analyst for PA
Sulekha Avasthi
savasthi@samvit-solution
s.com
Samvit Solutions
Analyst for Registry
Farhan Khan
[email protected]
om
Samvit Solutions
UI Engineer
Ben Traynham
ben.traynhamk@semantic
bits.com
SemanticBits
Role
Name
Email Address
Affiliation
Senior Technical Writer
Lauren Anthone
[email protected]
Independent
Technical Writer
Patrick McConnell
patrick.mcconnell@sema
nticbits.com
SemanticBits
Technical Writers
QA Team
Role
Name
Email Address
Affiliation
QA
Vivek Ramani
[email protected]
SAIC-F
QA
Paula Brown
[email protected]
ESI
| File Type | application/pdf |
| File Modified | 2012-11-01 |
| File Created | 2012-11-01 |