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
	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 or Add Accrual 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.

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Sheet 2: Input

Study Details

*Study Id

Change Code

Add Accrual

Change Code

*Country of Residence

*Gender of a Person

*Ethnicity

Payment Method

*Race

*Subject Disease Code

1

AF

Female

Hispanic or Latino

Managed Care

American Indian or Alaska Native

SDC

Complete Trial Details

2

AL

Male

Not Hispanic or Latino

Medicare

Asian

ICD-9

*Study Subject Identifier

DZ

Unknown

Not Reported

Medicaid

White

ICD-10

*Zip Code (if US)

AS

Unspecified

Unknown

Medicaid and Medicare

Black or African American

ICD-O-3

*Country of Residence

AD

Medicare and Private Insurance

Not Reported

*Patient’s Date of Birth

AO

Military or Veterans Sponsored, NOS

Unknown

*Gender of a Person

AI

Military Sponsored (Including CHAMPUS & TriCare)

Native Hawaiian or Other Pacific Islander

*Ethnicity

AQ

No Means of Payment (No Insurance)

Payment Method

AG

Other

*Subject Registration Date

AR

Private Insurance

Registering Group Identifier

AM

Self-Pay (No Insurance)

*Study Site Identifier

AW

State Supplemental Health Insurance

*Subject Disease Code

AU

Unknown

*Race

AT

Veterans Sponsored

Race

AZ

Race

BS

Race

BH

BD

BB

BM

BT

BO

BA

BW

BV

BR

IO

BN

BG

BF

BI

KH

CM

CA

CV

KY

CF

TD

CL

CN

CX

CC

CO

KM

CG

CD

CK

CR

CI

HR

CU

CY

CZ

DK

DJ

DM

DO

TP

EC

EG

SV

GQ

ER

EE

ET

FK

FO

FJ

FI

FR

FX

GF

PF

TF

GA

GM

GE

DE

GH

GI

GR

GL

GD

GP

GU

GT

GN

GW

GY

HT

HM

VA

HN

HK

HU

IS

IN

ID

IR

IQ

IE

IL

IT

JM

JP

JO

KZ

KE

KI

KP

KR

KW

KG

LA

LV

LB

LS

LR

LY

LI

LT

LU

MO

MK

MG

MW

MY

MV

ML

MT

MH

MQ

MR

MU

YT

MX

FM

MD

MC

MN

MS

MA

MZ

MM

NA

NR

NP

NL

AN

NC

NZ

NI

NE

NG

NU

NF

MP

NO

OM

PK

PW

PA

PG

PY

PE

PH

PN

PL

PT

PR

QA

RE

RO

RU

RW

KN

LC

VC

WS

SM

ST

SA

SN

SC

SL

SG

SK

SI

SB

SO

ZA

GS

ES

LK

SH

PM

SD

SR

SJ

SZ

SE

CH

SY

TW

TJ

TZ

TH

TG

TK

TO

TT

TN

TR

TM

TC

TV

UG

UA

AE

GB

US

UM

UY

UZ

VU

VE

VN

VG

VI

AX

BL

GG

IM

JE

ME

MF

PS

RS

TL

WF

EH

YE

ZM

ZW

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Sheet 3: Collections

Study Id

Change Code

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Sheet 4: Patients

Study Id

Study Subject Identifier

Zip Code (if US)

Country of Residence

Patient’s Date of Birth

Gender of a Person

Ethnicity

Payment Method

Subject Registration Date

Registering Group Identifier

Study Site Identifier

Subject Disease Code

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Sheet 5: Races

Study Id

Study Subject Identifier

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

Data Element	Definition
*Study Id	This is the unique identifier assigned to the study.
Change Code	Whether the data has not changed since the last report
*Study Subject Identifier	Unique identifier (PO ID) assigned to the institution accruing the patient to the study.
*Zip Code (if US)	The 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 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.
*Country of Residence	For non-U.S. residents only. This should be used when patient participation from foreign countries is involved. For patients from outside the U.S., enter the foreign country code. Leave blank if the patient is a U.S. resident. CTRP is using the International Standards Organization country codes. Note: Either Zip code (if U.S resident) or country code (if not U.S resident) is mandatory.
*Patient’s Date of Birth	The month and year on which the person was born
*Gender of a Person	Text designations that identify gender. Gender is described as the assemblage of properties that distinguish people on the basis of their societal roles.
*Ethnicity	The text for reporting information about ethnicity based on the Office of Management and Budget (OMB) categories.
Payment Method	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.<y.
*Subject Registration Date	Date the subject was registered for the study.<y.
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
*Subject Disease Code	Code that identifies a disease.< study.<y.
*Race	The text for reporting information about race based on the Office of Management and Budget (OMB) categories.<y.
*Study Site Accrual Count	Numeric count of subjects accrued at a study site to date