Form 6 Attach 5c Accural Batch File Tool

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Overview

Instructions
Input
Collections
Patients
Races
Accrual Count
Export
Definitions

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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

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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

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Sheet 3: Collections

Study Id

Change Code

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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

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Sheet 5: Races

Study Id

Study Subject ID

Race

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Sheet 6: Accrual Count

Study Id

Study Site Identifier

Study Site Accrual Count

Cut-Off Date

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Sheet 7: Export

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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