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Contents

Purpose

Record course initiation details required per protocol, which may include: start date, course (e.g. cycle), treatment arm, treatment assignment code (TAC) and treating institution.

Course Initiation eCRF

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the course started.

DD-MMM-YYYY

Course #(d)

Sequential number of this course of treatment: first course = 1, second course = 2, etc.

5 digits

Start Date of Course(m)

Enter the date on which the course was started. This is the date on which a protocol stipulated medication (or treatment) was first administered.

DD-MMM-YYYY

Arm(m)

Select the "Arm" of the protocol-specific treatment regimen the patient received, if applicable. This information would have been provided by the Central Registration Office (CRO) at time of study enrollment. Refer to the patient's Activation Letter issued by the CRO for details.

Use pick list.

Treatment Assignment Code(m)

Select the appropriate code for the patient's treatment assignment as specified in the protocol. For some BTTC protocols, there will be no TAC to enter. 

Use pick list.

Treating Institution(m)

Select the unique BTTC institution code where the patient received this course of treatment.

Use pick list.

Legend: (d) derived field, (m) RDC mandatory

Validations

Code

Description

Resolutions

CINI01

Start Date of Course cannot be in the future.

Change the Start Date of Course to a date no later than the current date.

CINI03

Course start dates must be unique and in order.

Ensure that no course start dates are repeated and that they appear in the correct chronological order (from the oldest to the more recent).

CINI04

If course initiation number is greater than 1, then prior course should exist first.

Ensure the previous course was entered

Derivations

Code

Field Name

Description

CINI1002

Course #

Course number derived by the system based on the dates the courses started.

Last updated by Blackburn, Katie (NIH/NCI) [C] on Apr 18, 2017