Contents

Purpose

Record details of prior therapies related to the disease being studies by the protocol or when the details would be clinically significant for the evaluation of this study as indicated on the Prior Treatment Summary case report form.

Prior Therapy 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

Date of First Dose^(m)^

Enter the date of the first dose of the prior therapy. Partial dates are acceptable when the day is not known.

DD-MMM-YYYY or MMM-YYYY

Date of Last Dose

Enter the date of the last dose of the prior therapy. Partial dates are acceptable when the day is not known. Leave it blank if the treatment is currently being received. “Ongoing’ will be reported to CTMS or CDS.

DD-MMM-YYYY, MMM-YYYY

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.

Schedule

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

24 characters

Total Dose

Enter the total dose of the agent.

8 characters

Total Dose UOM

Enter the total dose units of measurement.

12 digits

Total No.of Courses Administered

Enter the total number of cycles or courses of the specified drug or therapy agent administered to the patient as of the reported period

3 digits

Best Response

Select the best response encountered:
CR - Complete Response
MR - Minimal/Marginal Response
NA - Not Assessed
NE - Not Evaluable
PD - Progressive Disease
PR - Partial Response
SD - Stable Disease
UK - Unknown
Leave this field blank if the treatment is ongoing.

Use pick list.

NonResponse Therapy Type

Select the therapy type for which the conventional response calls are not appropriate.
AJ - Adjuvant Therapy
PA - Palliative Therapy
NJ - Neoadjuvant Therapy

Use pick list.

Therapy Type^(m)^

Select the appropriate type of prior therapy:

  • Anti-Retroviral Therapy
  • Antisense
  • Bone Marrow Transplant
  • Chemotherapy (NOS)
  • Chemotherapy multiple agents systemic
  • Chemotherapy non-cytotoxic
  • Chemotherapy single agent systemic
  • Gene Transfer
  • Hormonal Therapy
  • Drug and/or Immunotherapy

  • Immunotherapy

    Note: Do not use Immunotherapy for CTEP sponsored studies (CTMS and CDUS reporting).

  • Oncolytic Virotherapy
  • Vaccine
  • Prior Therapy (NOS)
  • Hematopoietic Stem Cell Transplantation
  • Image Directed Local Therapy
  • No prior Therapy

Use pick list.

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

Validations

Code

Description

Resolutions

PTS01

Date of First Dose is greater than Date of Last Dose.

Enter a Date of First Dose that is equal to or earlier than the Date of Last Dose.

PTS02,
PTS03

Date of First Dose and Date of Last Dose are in the future.

Enter a date that is equal to or earlier than the current date.

PTS04

Both Best Response and Nonresponse Therapy Type are present/absent.

One and only one fields should be entered.

Derivations

Code

Field Name

Description

PTS1001

Therapy Type

Derive Therapy Type Code based on matching Therapy Type
Last updated by Karuppiah, Ramesh (NIH/OD) [E] on Jun 07, 2018