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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
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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 | ||
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 Type | Term to describe the number of agents included in therapy regimen:
| Use pick list. | ||
Post-Therapy Followup Agent Name | Select the generic name of the agent that was used.
| 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. | Use pick list. | ||
Best Response | Select the best response encountered: | Use pick list. |
Legend: (m) RDC mandatory. |
Validations
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Derivations
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