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Contents

Purpose

The purpose of this Case Report Form (CRF) is to record details about when a patient comes off study. Record information concerning the patient's off study date and reason, after the patient has been taken off study. No further data will be collected once this form is completed.

For Protocol 17-C-0034, subjects identified as screen failures (i.e. ineligible diagnosis), complete the Off Study Case Report Form and in addition, the following CRFs must be completed:

Enrollment CRF
Prior Surgery (if patient had previous biopsy OR previous surgery)
Surgery
Specimen_Screening (if patient had surgery)
Medical History
Physical Screening
Adverse Events (with amendment B – Adverse events that occur after the consent form is signed but before treatment (RT, Pembrolizumab, TMZ) must be collected by the investigator only if they cause the subject to be excluded from the trial.)
Off Study

For studies without a protocol specified follow-up period: This CRF is completed at the same time the Off Treatment CRF is completed. The off study date, reason and explanation must be the same as the off treatment CRF (date, reason and explanation respectively).

For studies with a protocol specified follow-up period: This form is completed when all long-term follow-up time points and data have been collected as specified in the protocol. It would also be completed if the patient dies within the follow-up period or if follow-up period ends for any other reason (e.g. patient withdraws consent). If the off treatment reason prevents the follow-up period from occurring, then the off study date, reason and explanation must be the same.

Off Study eCRF

Field Name	Description / Instructions	Format
Visit Date^(m)	Enter the date the form is being completed.	DD-MMM-YYYY
Date Off Study^(m)	For protocols with a specific follow-up period, enter the date that corresponds to the date when all protocol specific follow-up has been completed. For protocols without a protocol specific follow-up, enter the date that the patient came off treatment, i.e. courses have been completed (including the normal observation period) or discontinued and no further treatment courses are planned. This date must be the same as the Date Off Treatment entered on the Off Treatment case report form. The date off study will correspond to a progress note in the medical record stating that the patient has been taken off study.	DD-MMM-YYYY
Reason Off Study^(m)	For protocols without an off treatment protocol-specific follow-up period, use the same 'Reason Off Treatment' entered on the Off Treatment case report form. For protocols with an off-treatment protocol-specific follow-up period, select one of the following off study reasons: Y - Completed treatment period but refused the Protocol-Specified Follow-up. Date Off Treatment and Date Off Study must be the same. H - Follow-up Period Completed: The patient completed all protocol specified follow-up evaluations. L - Lost to Further Follow-up: Follow-up information could not be obtained because contact with the patient was lost. Every effort to locate patient needs to be considering including: contact with family members, referring physicians, sending certificate letter, checking SSDI. W - Refused Further Follow-up: The patient has refused to have any further follow-up evaluations. M - Death during Follow-up Period: The patient died during the follow-up phase of the protocol. The Date Off Study must coincide with the date of death (located on the Survival case report form). J - Disease Progression during Follow-up Period: The patient was taken off study for disease progression during the follow-up period. A Date of Progression must be entered. K - Other Reasons: Other reasons may be given for taking the patient off study. Enter an explanation in the "Explain 'Other' Reason" field.	Use pick list.
Explain 'Other' Reason	Enter an explanation for selecting "Other" for a Reason Off Study. For protocols without a protocol specific follow-up, repeat the same explanation entered on the Off Treatment case report form.	24 characters
Date of Disease Progression	If disease progression is selected as the reason the patient came off study, enter the date the disease assessment (i.e.: CT scan) was performed.	DD-MMM-YYYY

Legend: ^(m) RDC mandatory

Validations

Code	Description	Resolutions
OSS13, OSS14	Date Off Study and/or Date of Progression cannot be a date in the future.	Enter a date earlier than, or equals to, the current date.
OSS01	Reason Off Study is 'Death' and Date Off Study is not equal to Date of Death on Survival form.	If patient died during the protocol follow-up period or during treatment, Date Off Study must coincide with Date of Death.
OSS03	Reason Off Study is Protocol Violation and a comment with the off study date does not exist.	If patient treatment was terminated due to Protocol Violation, then reason must be stated in the Comments tab of this form.
OSS18	Explain 'Other' Reason provided, but Reason Off Study is not 'U', 'O' or 'K'.	Only 'Other' reasons can have an explanation.
OSS19	Reason Off Study is 'U', 'O' or 'K' and Explain 'Other' Reason not provided.	'Other' reasons must have an explanation in the Explain 'Other' Reason field.
OSS20	Date Off Study and Date Off Treatment are the same, but Reason Off Study is not "Y - Refused participation in follow-up", or "K - Other" or the same as the Reason Off Treatment.	When the Date Off Treatment and Off Study are the same, the Reason Off Study must be the same as the Off Treatment Reason or "Y" or "K".
OSS21	Date of Disease Progression cannot be after Date Off Study	Enter a Date of Disease Progression that is earlier than or equal to the Date Off Study.
OSS22	Disease Progression selected as Reason Off Study and Date of Disease Progression is missing.	A Disease Progression for Reason Off Study requires a Date of Disease Progression.
OSS23	Date of Disease Progression provided and Reason Off Study is not Disease Progression.	Date of Disease Progression must be accompanied by a Reason Off Study of 'Disease Progression'.
OSS24	Off Treatment Date of Disease Progression is blank, Off Study Date of Disease Progression is not blank and it doesn't fall between the Date Off Treatment and Date Off Study.	Date of Disease Progression must be between Date Off Treatment and Date Off Study when progression did not occur during treatment – it occurred during the follow-up period.
OSS25	Reason Off Treatment is Disease Progression, Date Off Treatment and Date Off Study are the same and Date of Disease Progression is not the same as the one in the Off Treatment form.	When Disease Progression is the Reason for Off Treatment and Off Study, then Date of Disease Progression must be the same on both forms.
OSS27	Off Study Date is provided but the Off Treatment Date is absent.	Enter the Off Treatment Date on Off Treatment form.