Contents

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

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.
Examples include, but not limited too: biopsy, node dissection, cytology, bone marrow biopsy, FNA (fine needle aspiration).

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:
Y - Yes
N - No

Use pick list.

Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.

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.