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Contents

Purpose

Record course initiation Start Date, 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 is to receive, as designated in the activation letter.

Note: Only mandatory for CTMS monitored, CTEP - sponsored studies.

Use pick list.

Treatment Assignment Code(m)(c)

Select the appropriate code for the patient's treatment assignment as specified.
For non-CTEP studies, "Treatment Assignment" codes are based on the treatment schedules described in the protocol. Please contact the Informatics team for advice on TAC formulation and modification.
For CTEP sponsored studies, "Treatment Assignment" codes are provided by CTEP to the investigator, in the form of a coding letter, at the time of protocol approval, and are updated as required following approval of protocol amendments.
Advice on TACs is available from the CTEP's Protocol and Information Office (pio@ctep.nci.nih.gov).

Use pick list.

Treating Institution(m)

Select the unique CTEP institution code where the patient actually receives this course of treatment.

Note: This pick list does not show all the Institutes. User must type in a search criterion and then click on the ellipsis perform the search and display the resulting matched Institutes. Ex: type %NCI% to list all the Institutes that include the upper characters ‘NCI’ somewhere in the Institute code.

Note: Optional for non-CTEP sponsored studies.

Use pick list.

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

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 Fontinha, Marcelo (NIH/NCI) [C] on Apr 12, 2012