1 CTRP Registration Complete Participating Sites Template

The Clinical Trials Reporting Program (CTRP) Database (NCI)

Attach_5B_CTRP_Registry_Complete_Trial_Participating_Sites_Template.xls

Registration for the Clinical Trials Reporting Program (CTRP) Database (NCI)

OMB: 0925-0600

Document [xlsx]
Download: xlsx | pdf

Overview

Disclaimer
Readme First
Template Instructions
Participating Site Data Spec
Collaborator Data Spec
Participating Site example
Collborator example


Sheet 1: Disclaimer



Sheet 2: Readme First

CTRP Trial Registration Participating Site Specification for Complete Trials







The participating sites template is designed for recording participating site data for interventional trials, especially if site-specific data is not included in the trial protocol.

About this Document




This document provides you with everything you need to upload clinical trial participating sites and collaborator data to the CTRP Trial Registration system, including the following:




Template Instructions


The Template Instructions worksheet provides detailed instructions for preparing your data and uploading them to the system.






Participating Site Data Specification and Collaborator Data Specification


The specifications worksheets includes the following information:

1 Data elements

2 Order in which the data elements must be presented

3 Data element requirements

4 Valid values. The system accepts only those values listed in this document

5 Notes. Additional information that helps you to ensure successful submission of your data



Participating Site and Collaborator Examples


These worksheets provide examples of a typical participating sites/collaborator data file.

Sheet 3: Template Instructions

How to Submit Complete Trial Participating Sites Data to the CTRP Trial Registration System










Main Steps for Uploading Your Data




1 Prepare the trial data file
2 Upload the file in the Trial-Related Documents section in the Registration application



Preparing Trial Data Files




1 Ensure that your trial conforms to the supported criteria. This template supports the following:




* Interventional trials

* Complete trials (Summary 4 Funding Sponsor Category is National, Externally Peer Reviewed, or Institutional

* Processing Statuses for trial updates: Accepted and beyond

* Processing Statuses for trial amendments: Abstraction Verified Response or Abstraction Verified No Response



2 Prepare an Excel spreadsheet (.xls) containing the mandatory and optional data for the trial(s) as specified in this document.




You must adhere to the following requirements:

* List trial elements required for registration in the order specified in the Abbreviated Trial Data Spec tab in this spreadsheet.

* Do not change the spelling of data elements or valid values.

* Conform to the valid values guidelines when entering trial data.

* Identify each trial uniquely

* Participating site information must include the following data elements:


* Study participating site data


* At least one study site investigator's information


* Participating site primary or central contact information. Generic contact information is accepted.


* Organization attribute


* Current recruitment status


* Status date


* Target accrual. This is mandatory if the target accrual is for a study at a participating site or if the lead organization is an NCI-designated Cancer Center. Optionally, provide a local trial identifier.

* Study site investigator's information must include the following data elements:


* Study site investigator data with person's attributes


* Investigator's role in the study at the site.


Note: When registering multiple investigators for a single trial, create one line per investigator/site, using the participating site number as reference.

* Participating site contact information is optional if the contact person is the investigator, or if the central contact information is provided.

* List persons and organizations with PO-IDs.


Note: You can request a list of CTRP persons and organizations along with PO-IDs from the CTRO at [email protected].

Or, you can use the organization/person lookup features in the CTRP Trial Registration application to search for PO-IDs.



Uploading Your File




Upload your file in the Trial-Related Documents section of the CTRP Registration Site's Register Trial page.










For detailed instructions for registering trials, refer to the NCI CTRP Reporting Program Registration Site User's Guide at:


https://wiki.nci.nih.gov/x/7qViAw

Sheet 4: Participating Site Data Spec

Element order Element Required? Allowed values Note



















Study participating site data

For participating sites only; lead organization must be included if it is also a participating site






1 Site # Yes
Order in the list of participating sites






2 Local Trial Identifier

Trial identifier at site






3 [Site] Organization PO-ID

PO-ID or organization mandatory attributes is required






4 [Site] Name Yes if PO-ID is not provided








5 [Site] Street Address Yes if PO-ID is not provided








6 [Site] City Yes if PO-ID is not provided








7 [Site] State/Province (US/Canada/Australia) Yes for US, Canada, Australia and if PO-ID is not provided
US, Canada, Australia only for the case when PO-ID is not provided






8 [Site] Zip/Postal code Yes if PO-ID is not provided








9 [Site] Country Yes if PO-ID is not provided








10 [Site] Email Yes if PO-ID is not provided








11 [Site] Phone









12 [Site] Phone extension

If exists and phone is provided






13 [Site] TTY









14 [Site] FAX









15 [Site] URL









16 Is it NCI designated cancer center? Yes Yes/No Indicate if organization is a NCI designated cancer center






17 Study Current Recruitment Status at site Yes Not yet recruiting; Recruiting; Enrolling by invitation; Active, not recruiting; Completed; Suspended; Terminated; Withdrawn







18 Study Current Recruitment Status date Yes Date in the format mm/dd/yyyy Date that corresponds to the current recruitment status change






19 Site Target Accrual Yes if either site or lead organization is cancer center Number Mandatory if either site or lead organization is cancer center






20 Program Code

Site-specific Summary 4 program code for NCI designated cancer center







Study site investigator's information

Several records per one participating site are accepted






21 Investigator's Person PO-ID

Person PO-ID or all mandatory person attributes is required






22 Investigator's First Name Yes if PO-ID is not provided








23 Investigator's Middle name

Only initials






24 Investigator's Last Name Yes if PO-ID is not provided








25 Investigator's Email Yes if PO-ID is not provided
Email address specific to study






26 Investigator's Phone Yes if PO-ID is not provided
Phone specific to study






27 Investigator's Phone Extension

Mandatory if exists and PO-ID is not provided






28 Investigator's Street Address Yes if PO-ID is not provided








29 Investigator's Zip/Postal Code Yes if PO-ID is not provided








30 Investigator's City Yes if PO-ID is not provided








31 Investigator's State/Province (US/Canada, Australia) Yes if country is US, Canada, Australia and PO-ID is not provided
Only for US/Canada/Australia in case if PO-ID is not provided






32 Investigator's Country Yes if PO-ID is not provided








33 Investigator's TTY









34 Investigator's FAX









35 Investigator's URL









36 Investigator's Role in the study Yes Principal Investigator, Sub-Investigator







37 Use investigator as site contact for the study Yes Yes/No IF YES is selected, investigator will play participating site contact role for the study and no other participating site contact will be required







Study/Site Contact information









38 Contact type Yes Site-Specific, Study-specific or central Provide single contact for the study (study-specific) or site-specific contact for each participating site. This attribute is not required if site's investigator is assigned as site contact. There is no need to replicate central contact in each participating site record if central contact is selected and provided in the first record







Generic Contact

Generic contact or personal contact is required






39 Title for generic contact Yes if generic contact is used
Several records per one participating site are accepted in case of site-specific contact type






40 Contact Email Yes if generic contact is used
Email address specific to study






41 Contact Phone Yes if generic contact is used
Phone specific to study






42 Contact Phone Extension

Mandatory if exists







Personal Contact









43 Contact Person's PO-ID

PO-ID or all mandatory person attributes is required






44 Contact Person's First Name Yes if personal contact is used and PO-ID is not provided
Several records per one participating site are accepted in case of site-specific contact type






45 Contact Person's Middle Name

Only initials






46 Contact Person's Last Name Yes if personal contact is used and PO-ID is not provided








47 Contact Email Yes if personal contact is used and PO-ID is not provided
Email address specific to study






48 Contact Phone Yes if personal contact is used and PO-ID is not provided
Phone specific to study






49 Contact Phone Extension

Mandatory if exists and the phone is provided






50 Contact Person's Street Address Yes if personal contact is used and PO-ID is not provided








51 Contact Person's Zip/Postal Code Yes if personal contact is used and PO-ID is not provided








52 Contact Person's City Yes if personal contact is used and PO-ID is not provided








53 Contact Person's State/Province (US/Canada/Australia) Yes for personal contact and if country is US, Canada, Australia
Only for US/Canada/Australia in case if PO-ID is not provided






54 Contact Person's Country Yes if personal contact is used and PO-ID is not provided








55 Contact Person's TTY









56 Contact Person's FAX









57 Contact Person's URL










Sheet 5: Collaborator Data Spec

# Element Mandatory? Value Note







Collaborator information Optional


1 Collaborator #

Order in the list of collaborators
3 Collaborator Organization PO-ID

PO-ID or all mandatory organization attributes is required
2 Collaborator Name Yes if PO-ID is not provided


4 Collaborator Street Address Yes if PO-ID is not provided


5 Collaborator City Yes if PO-ID is not provided


6 Collaborator State/Province (US/Canada/Australia) Yes for US, Canada, Australia and PO-ID is not provided
US, Canada, Australia only in case if PO-ID is not provided
7 Collaborator Zip/Postal code Yes if PO-ID is not provided


8 Collaborator Country Yes if PO-ID is not provided


9 Collaborator Email Yes if PO-ID is not provided


10 Collaborator Phone



11 Collaborator Phone extension

If exists and phone is provided
12 Collaborator TTY



13 Collaborator FAX



14 Collaborator URL



15 Collaborator role on the study Yes if PO-ID is not provided Funding Source, Agent Source, Laboratory


Sheet 6: Participating Site example


1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37
38
39 40 41 42
43 44 45 46 47 48 49 50 51 52 53 54 55 56 57


Site info Site # Local Trial Identifier [Site] Organization PO-ID [Site] Name [Site] Street Address [Site] City [Site] State/Province (US/Canada) [Site] Zip/Postal code (US/Canada) [Site] Country [Site] Email [Site] Phone [Site] Phone extension [Site] TTY [Site] FAX [Site] URL Is it NCI designated cancer center? Study Current Recruitment Status at site Study Current Recruitment Status date Site Target Accrual Program Code Site Investigator Investigator's Person PO-ID Investigator's First Name Investigator's Middle name Investigator's Last Name Investigator's Email Investigator's Phone Investigator's Phone Extension Investigator's Street Address Investigator's Zip/Postal Code (US/Canada) Investigator's City Investigator's State/Province (US/Canada) Investigator's Country Investigator's TTY Investigator's FAX Investigator's URL Investigator's Role in the study Use investigator as site contact for the study Site Contact Info Contact type Genetic Contact Title Contact Email Address Contact Phone Contact Phone Extension Personal Contact Contact Person's PO-ID Contact Person's First Name Contact Person's Middle Name Contact Person's Last Name Contact Email Contact Phone Contact Phone Extension Contact Person's Street Address Contact Person's Zip/Postal Code (US/Canada) Contact Person's City Contact Person's State/Province (US/Canada) Contact Person's Country Contact Person's TTY Contact Person's FAX Contact Person's URL
Note
Study 1
































































1 LI01
The University of Texas M. D. Anderson Cancer Center 1515 Holcombe Blvd Houston TX 77030 USA [email protected] (713) 792-5410


http://www.mdanderson.org YES recruiting 10/20/2008 55 BM3

Mary A Simpson [email protected] (713) 792-5410 235 1515 Holcombe Blvd 77030 Houston TX USA


Principal Investigator YES
Site-Specific





















Site is a NCI designated cancer center, includes 2 investigators. One of the investigators is selected as this site contact.

1




















Brandy S White [email protected] (713) 792-5410 254 1515 Holcombe Blvd 77030 Houston TX USA


Sub-investigator NO


























2 LI02
Memorial Sloan-Kettering Cancer Center 1275 York Avenue New York NY 10065 USA [email protected] 212-639-2000


http://www.mskcc.org YES recruiting 11/2/2008 125


Helen T Harold [email protected] 212-639-2000 3224 1275 York Avenue 10065 New York NY USA


Principal Investigator NO
Site-Specific






Terry
Smith [email protected] 212-639-2000 4444 1275 York Avenue 10065 New York NY USA



Site is a NCI designated cancer center, includes 1 investigator. Site-Specific contact is used (investigator is not used for site contact)
Study 2
































































1 LI04
Memorial Sloan-Kettering Cancer Center 1275 York Avenue New York NY 10065 USA [email protected] 212-639-2000


http://www.mskcc.org YES recruiting 11/2/2008 125


Helen T Harold [email protected] 212-639-2000-145 3224 1275 York Avenue 10065 New York NY USA


Principal Investigator NO
Study_specific
Clinical Study Department [email protected] 212-639-2000 123
















Generic study-specific contact is used; no need to provide contact for each site separately.

2 LI06
The University of Texas M. D. Anderson Cancer Center 1515 Holcombe Blvd Houston TX 77030 USA [email protected] (713) 792-5410


http://www.mdanderson.org YES recruiting 10/20/2008 55 BM3

Mary A Simpson [email protected] (713) 792-5410 235 1515 Holcombe Blvd 77030 Houston TX USA


Principal Investigator NO


























Sheet 7: Collborator example

1 3 2 4 5 6 7 8 9 10 11 12 13 14 15
Collaborator # Collaborator Organization PO-ID Collaborator Name Collaborator Street Address Collaborator City Collaborator State/Province (US/Canada) Collaborator Zip/Postal code (US/Canada) Collaborator Country Collaborator Email Collaborator Phone Collaborator Phone extension Collaborator TTY Collaborator FAX Collaborator URL Collaborator role on the study
1
Publitek, Inc. dba Fotosearch 21155 Watertown Road Waukesha WI 53186-1898 USA [email protected] 1-800-827-3920

262-717-0745 http://www.fotosearch.com Laboratory
2
AstraZeneca International P.O. Box 15437 Wilmington DE 19850-5437 UK [email protected] 1 302 886 3000

302 886 2972 www.astrazeneca-us.com Agent Source
File Typeapplication/vnd.ms-excel
Authornshimko
Last Modified ByDavid Loose
File Modified2013-04-03
File Created2008-12-04

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