Contents |
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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 |
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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: | Use pick list. |
NonResponse Therapy Type | Select the therapy type for which the conventional response calls are not appropriate. | Use pick list. |
Therapy Type^(m)^ | Select the appropriate type of prior therapy:
| Use pick list. |
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.
Validations
Code | Description | Resolutions |
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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, | 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 |
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PTS1001 | Therapy Type | Derive Therapy Type Code based on matching Therapy Type |