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Contents

Purpose

This Case Report Form (CRF) is required when a patient stops treatment and begins a new anticancer therapy. Record details of post therapies related to the disease being studied (i.e. brain tumor). You may also record any treatment details that would be clinically significant for the evaluation of this study as indicated on the Post Treatment Summary CRF.

Post Treatment Supplement eCRF

 

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the form was completed (i.e. the date information was gathered).

DD-MMM-YYYY

Start Date(m)

Enter the date the patient received the first dose of the new anti-cancer therapy (i.e. the next post-protocol therapy). Partial dates are acceptable when the day is not known.

DD-MMM-YYYY or MMM-YYYY

Stop Date

Enter the date the patient received the last dose of the post-protocol therapy. Partial dates are acceptable when the day is not known. Leave it blank if the treatment is currently being received. 

DD-MMM-YYYY, MMM-YYYY

Therapy TypeTerm to describe the number of agents included in therapy regimen: 
  • MULTIPLE AGENTS

  • SINGLE AGENT

  • UNKNOWN

Use pick list.

Post-Therapy Followup Agent Name

Select the generic name of the agent that was used.

Note: For standard regimen (multiple agents given as one regimen), enter one record for each agent.

Use pick list.

Total Dose

Enter the total dose of the agent.

8 digits, 3 decimal

Total Dose UOM

Enter the total dose units of measurement.

16 digits

Schedule

Select the schedule on which the agent (or combination) was given. (Optional field)

24 characters

Route

Select the route from the list.

16 characters

Duration(m)

Enter the duration calculated from the start date/time and stop date/time.

6 digits, 2 decimal

Duration UOM(m)

Select the units of measurement so that the duration can be derived.
DY - Days
HR - Hours
MN - Minutes
MO - Months
WK - Weeks
SEC- Seconds

Use pick list.

Best Response

Select the best response encountered:
CR - Complete Response 
PD - Progressive Disease
PR - Partial Response
SD - Stable Disease 
UK - Unknown
Leave this field blank if the treatment is ongoing.

Use pick list.

Legend:  (m) RDC mandatory.

 

Validations

Code

Description

Resolutions

 

 

 

 

 

 

 

 

 

Derivations

Code

Field Name

Description

 

 

 

 

 

 

 

 

 

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