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. | 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. |