Contents |
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Purpose
Record details of prior surgery related to the disease being studies by the protocol or when the details would be clinically significant for the evaluation of this study.
Prior Surgery Supplement 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 |
Date of Surgery(m) | Enter the date of the surgical procedure. Partial dates are acceptable when the day is not known. | DD-MMM-YYYY or MMM-YYYY |
Procedure(m) | Enter the type of procedure performed to diagnose / to treat the patient's disease. | 50 characters |
Site(m) | Select the anatomical site of the procedure. | Use pick list. |
Findings | Briefly describe the findings of the procedure. | 24 characters |
Residual Disease | Briefly describe the extent of the residual disease, if any, at the conclusion of the operation. (i.e.: microscopic, macroscopic). | 24 characters |
Therapeutic? | Select if the surgical procedure was performed with curative intent: | Use pick list. |
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.
Validations
Code | Description | Resolutions |
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PSG01 | Date of Surgery is in the future. | Enter a date that is equal to or earlier than the current date. |