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Purpose
Record details of prior surgery related to the disease being studied by the protocol or when the details would be clinically significant for the evaluation of this study. Note: Baseline Disease Assessment is using "Response Type- Lesion Size" and "Response Criteria Type- RANO"
Baseline Disease Assessment eCRF
Field Name | Description / Instructions | Format |
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Visit Date(m) | Enter the date the form was completed. Note: If the information was obtained at multiple visits, please enter the date the form was completed. | DD-MMM-YYYY |
Is pt NED?(m) | Indicate whether there is no evidence of disease (NED) at assessment.
| Use pick list. |
Max Daily Corticosteroid Dose at assessment | Enter the numeric value for the largest daily corticosteroid dose taken by a patient at the time of an assessment. | 8 digits and 2 decimals |
Max Daily Corticosteroid Dose UOM | Select the total daily dose units of measurement. | Use pick list |
Steroid dose status | Indicate the status that represents the steroid therapy dose.
| Use pick list. |
Sum of Longest Diameters of all Measurable Lesions (cm)(m) | Enter the numeric value to indicate the sum of the longest diameters of all measurable lesions captured in centimeters (cm). | 6 digits and 2 decimals |
Sum of TD x PD of all Measurable Lesions (cm2)(m) | Enter the numeric value for total sum of products (transverse diameter multiplied by perpendicular diameter) for all measurable lesions described in square centimeters (cm2). | 10 digits and 2 decimals |
Verifying physician(m) | Enter the name of the doctor, a person who has been educated, trained, and licensed to practice the art and science of medicine; a practitioner of medicine, as contrasted with a surgeon, responsible for verification. | 100 characters |
Verified(m) | Select the term used primarily by a physician to confirm or indicate whether revision in a patient's disease evaluation assessment is needed. •CONFIRMED | Use pick list. |
Date verified(m) | Enter the calendar date on which a physician confirms or indicates whether revision in a patient's disease evaluation assessment is needed. | DD-MMM-YYYY |
Legend: (m) RDC mandatory
Validations
Code | Description | Resolutions |
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Derivations
Code | Field Name | Description |
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