Visit
Indicate the phase of the study in which the protocol deviation occurred. If the protocol deviation was not associated with a phase, select “Not associated with a visit”.
- Screening
- Eligibility
- Pre-Transplant
- Infusion
- Post-Transplant
- Not associated with a visit
Date of deviation _______
Report the date the protocol deviation occurred in the DD/MMM/YYYY format.
Type of deviation
Select the type of deviation (see table below). Options include informed consent, subject eligibility criteria, adverse event report, or IRB deviations. If the deviation type was related to source documentation or another type of deviation, select “Other.”
- Informed Consent
- Lab / assessment requirement
- Investigational product
- Subject eligibility criteria
- Adverse event reporting
- IRB
- Subject visit
- Other
Specify type of deviation
Indicate the type of deviation that best describes deviation.
- Source documentation
- Other
Reason for deviation
Indicate if the deviation is site or subject related and specify from the list provided. If reason is not provided, select other and specify.
Site related
Specify Reason
- Staff not available
- Investigator oversight
- Laboratory error
- Other, specify
Subject related
Specify reason
- Subject refused
- Subject cancelled appointment
- Subject medical condition
- Other, specify
Is this deviation reportable to the IRB
Indicate if the deviation is reportable to the IRB of record.
CCG v.1 | CRF v.1
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