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)
- Specimen_Screening (if patient had surgery)
- Adverse Events
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
Description / Instructions
Enter the date the form is being completed.
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.
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.
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.
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.
Legend: (m) RDC mandatory
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.
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.
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.
Explain 'Other' Reason provided, but Reason Off Study is not 'U', 'O' or 'K'.
Only 'Other' reasons can have an explanation.
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.
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".
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.
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.
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'.
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.
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.
Off Study Date is provided but the Off Treatment Date is absent.
Enter the Off Treatment Date on Off Treatment form.