Contents |
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Purpose
Record details of prior therapies related to the disease being studied by the BTTC protocol. Also record any details that the investigator deems to be clinically significant for the evaluation of this study (if noted on the Prior Treatment Summary CRF).
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 |
No of Prior Regimens | Enter the number counting the total regimens of any therapy the patient received prior to enrolling the current protocol, where multiple drugs or a staged therapy count as a single regimen. | 2 digits |
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 |
Therapy Type(m) | Select the appropriate type of prior therapy:
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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. |
Systemic Therapy Relapse Date | Enter calendar date of return of disease following systemic therapy with a period of improvement or complete remission. | DD-MMM-YYYY |
Non-Response Therapy Type | Select the therapy type for which the conventional response calls are not appropriate. | Use pick list. |
Therapy Intent | Select text term to represent the anticipated outcome that is intended or that guides the delivery of a treatment plan.
| Use pick list. |
Regimen Type | Select the term to describe the number of agents included in therapy regimen.
| Use pick list. |
Legend: (m) RDC mandatory
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 |