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Purpose

Record information concerning the patient's off study date and reason. Complete this form after the patient has been taken off study.

For studies without a protocol specified follow-up period, this form is completed when the patient is taken off treatment. The off study date, reason and explanation must be the same as the off treatment case report form date off treatment, reason and explanation respectively.

For studies with a protocol specified follow-up period, this form is completed when all follow-up time points and data have been collected as specified in the protocol or if the patient dies within the follow-up period or if follow-up period ends for any other reason. If the off treatment reason prevents the follow-up period from occurring, then the off study date, reason and explanation must be the same.

No further data will be collected once this form is completed.

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.

Note: For CTMS studies, this is the 'Date off follow-up period'.

DD-MMM-YYYY

Reason Off Study(m)

For protocols without a protocol specific follow-up, use the same 'Reason Off Treatment' entered on the Off Treatment case report form.
For protocols with a follow-up period, the following off study reasons are also available.
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.

Note: For CTMS protocols, the actual Reason Off Study sent is 'K' and the explanation text is - 'Disease Progression during Follow-up Phase'.

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.

Note: This date is not sent to Theradex since only Disease Progression during treatment is to be reported.

DD-MMM-YYYY

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

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.