6 Attach 5c Accural Batch File Tool

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

Attachment 5c - Accrual Batch File Tool (2).xlsm

OMB: 0925-0600

Document [xlsx]
Download: xlsx | pdf

Overview

Instructions
Input
Collections
Patients
Races
Accrual Count
Export
Definitions


Sheet 1: Instructions


CTRP Accruals Spreadsheet









Revision Purpose Date Author





1.0 Initial draft 9/23/2012 Patrick McConnell





1.1 Changed language 10/10/2012 Patrick McConnell





1.2 Changed language 10/17/2012 Patrick McConnell





1.3 Multi-study support 11/30/2012 Patrick McConnell





1.4 Fixed bugs reported by QA 12/26/2012 Patrick McConnell





1.5 Added country codes to fix PO-8965 reported by QA 10/19/2015 Reshma Koganti





1.6 Added Cut-Off Date 9/7/2017 Praneeth Polavarapu





1.7 Removed validation for the subject disease code 9/11/2017 Praneeth Polavarapu





1.8 Fix for export complete trials 2/8/2018 Praneeth Polavarapu





1.9 Changed race "Native Hawaiian or other Pacific Islander" to "Native Hawaiian or Other Pacific Islander" 11/29/2018 Reshma Koganti





2.0 Added instructions to Input page. Adjusted input page layout. 8/9/2019 Li Wang















Purpose








The purpose of this Workbook is to provide an mechanism to capture accruals data to be imported into the CTRP accruals application using the Batch Import functionality. This is an alternative to entering data directly into the CTRP Accruals application using the website, generating a batch upload file directly, or using the CTRP accruals APIs. The ultimate goal of using this Workbook is to export data for import into CTRP Accruals using the Batch Import function on the CTRP Accruals website. Use of that website is outside the scope of these instructions















Entering Data








Data can be entered either through the Input Worksheet or directly into the Collections, Patients, Races, and Accrual Count Worksheets. The Input Worksheet requires that you first enter study details into the first section and then click either the Complete Trials button or Abbreviated Trials button to view the rest of the fields that are available. Then, click the Add Subject, Add Partial Subject or Add Summary button respectively. If the data is valid and entered correctly, it will be moved into the correct worksheet. If you enter data into the Collections, Patients, Races, and Accrual Count Worksheets manually, you must insure that identifiers are correctly maintained across the spreadsheets and that the data is appropriately formatted. You can click the field names on the Input Worksheet to view the definition of the field.















Exporting Data








Data is exported to a CSV file by navigating to the Export Worksheet and clicking the Export button. You will be prompted for a file name, and any existing file will be overwritten. You can only export data for Complete Trials and Abbreviated trials separately by clicking the appropriate Export button. The study identifier is appended to the file name, and a different file is created for each study. Clicking the Clear All Data button will erase data from the Collections, Patients, Races, and Accrual Count worksheets.















Note








The Accrual Batch File Tool supports SDC, ICD-9, ICD-10, and ICD-O-3 patient disease codes. For ICD-O-3 code system, both disease code and disease site are required. Please add them into the Subject Disease Code field. Delimited by semicolon





Sheet 2: Input

Study Details






*Study Id
Change Code





















































Complete Trial Details Instructions






*Study Subject ID
Subject Birth Date Format: MM/YYYY
The subject's age reported in CTRP cannot be greater than 125 years.

Subject Registration Date Format: MM/DD/YYYY

Subject Disease Code: For ICD-O-3 disease code system, please add both disease code and disease site to this field. Delimited by a semicolon. For example: 8543/3;C50.4

ZIP code is required for US, US territories and outlying islands that use the US Postal Codes.

Zip code must be a five-digit or a nine-digit (DDDDD-DDDD) value.







*Study Subject Zip Code







*Study Subject Country







*Study Subject Birth Date







*Study Subject Gender







*Study Subject Ethnicity







Study Subject method of payment







*Registration Date







Registering Group Identifier







*Study Site Identifier







*Subject Disease Code







*Race







Race







Race








Race















































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































































Sheet 3: Collections

Study Id Change Code

Sheet 4: Patients

Study Id Study Subject ID Study Subject Zip Code Study Subject Country Study Subject Birth Date Study Subject Gender Study Subject Ethnicity Study Subject method of payment Registration Date Registering Group Identifier Study Site Identifier Subject Disease Code

Sheet 5: Races

Study Id Study Subject ID Race

Sheet 6: Accrual Count

Study Id Study Site Identifier Study Site Accrual Count Cut-Off Date

Sheet 7: Export






















































































































Sheet 8: Definitions



Required/Conditional
Data Element Definition Subject Partial Summary
Study Id This is the unique identifier assigned to the study. R R R
Change Code Whether the data has not changed since the last report


Study Subject ID Unique identifier (PO ID) assigned to the institution accruing the patient to the study. R R
Study Subject Zip Code The string of characters used to identify the five-digit or 9-digit Zone Improvement Plan (ZIP) code that represents the geographic segment that is a subunit of the ZIPcode, assigned by the U.S. Postal Service to a geographic location to facilitate mail delivery. Zip Code is mandatory if the patient’s Country of Residence is the U.S, U.S. territories and outlying islands C

Study Subject Country CTRP is using the International Standards Organization country codes. R

Study Subject Birth Date (MM/YYYY) The month and year on which the person was born
Note: The subject's age reported in CTRP cannot be greater than 125 years.
R

Study Subject Gender Text designations that identify gender. Gender is described as the assemblage of properties that distinguish people on the basis of their societal roles. R

Study Subject Ethnicity The text for reporting information about ethnicity based on the Office of Management and Budget (OMB) categories. R

Study Subject method of payment Text 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.


Registration Date Date the subject was registered for the study. R R
Registering Group Identifier Unique identifier (PO ID) assigned to the group that originally registered the patient for the study


Study Site Identifier Unique identifier (numeric or alphanumeric) assigned to the study site R R R
Subject Disease Code Code that identifies a disease R

Study Subject Race The text for reporting information about race based on the Office of Management and Budget (OMB) categories. R

Study Site Accrual Count Numeric count of subjects accrued at a study site to date

R
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File Modified0000-00-00
File Created0000-00-00

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