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
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Field Name | Description / Instructions | Format |
|---|---|---|
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 |
| Surgery Relapse Date | Enter the calendar date of return of disease following surgery with a period of improvement or complete remission. | DD-MMM-YYYY |
| Surgery Reason | Select text term to explain the surgical setting or reason surgery was used for a patient. | Use pick list. |
Procedure | Select the name of a surgical procedure used to resection or remove a portion of a brain lesion. | Use pick list. |
| Extent of tumor resection | Select the extent to which an abnormal mass of tissue that results from excessive cell division was surgically removed. | Use pick list. |
| Other Specify | The free-text field used to describe the name assigned to a surgical procedure done for diagnostic, surveillance, treatment, palliation, or study-directed purposes. | 200 characters |
| Surgery Organ | Select the named location with the central nervous system that was the site of a surgical procedure. | Use pick list. |
Surgery Site | Select the named and more specified location in the body that was the site of a surgical procedure. | Use pick list. |
| Surgery Location | Select the named location in the body for a surgical procedure. | Use pick list. |
| Site Location | Select the text term to identify the specified/detailed anatomic location of a malignant neoplasm that arises from or metastasize to structures within the cranium. | Use pick list. |
| Side Detail | Select specification relating to the side or laterality of an anatomic location. | Use pick list. |
Post-op Histologic Diagnosis | Select the brain tumor histologic term. | Use pick list. |
Histology Grade | Enter the histologic grade | 10 characters |
| CSF Cytology Results | Select the summary result of a cerebrospinal fluid (CSF) cytological laboratory finding. | Use pick list. |
| Did the patient re-initiate protocol Tx post-operatively? | Select from the yes/no indicator related to a patient initiating the administration of therapy. | Use pick list. |
Post-op Chemotherapy Start Date | Enter the calendar date on which a chemotherapy agent or regimen was started on a postoperative patient. | DD-MMM-YYYY |
| Post-op Radiographic Assessment Date | Enter the calendar date on which a radiographic assessment was done on a postoperative patient. | DD-MMM-YYYY |
Legend: (m) RDC mandatory
Validations
Code | Description | Resolutions |
|---|---|---|
PSG01 | Date of Surgery is in the future. | Enter a date that is equal to or earlier than the current date. |
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