Protocol Deviation

*The timeline requirement for this form is as follows:
Submission timeframe: within 30 business days of knowledge of the event.

A protocol deviation is any departure from the defined procedures and treatment plans as outlined in the protocol. Protocol deviations must be sent to the local IRB/IEC per their guidelines. The site PI/study staff is responsible for knowing and adhering to their IRB requirements.

!Note: If the protocol deviation occurred due to reasons associated with COVID-19, indicate “COVID-19 logistical barrier” for the reason the deviation occurred. Examples include: staffing limitation, institutional no-contact policy, etc.

Visit
Indicate which visit the protocol deviation occurred. Visit options include those listed below. If the protocol deviation was not associated with a visit, select “Not associated with a visit.”

• Screening
• Eligibility
• Baseline
• Day 100
• Day 180
• Day 365
• Not associated with a visit
  

Date of deviation:
Enter the date the deviation occurred in DD/MMM/YYYY format.

Deviation type:
Select the type of deviation (see Table 1 below). Options include informed consent, lab / assessment requirement, investigational product, subject eligibility criteria, adverse event report, IRB, or subject visit deviations. If the deviation type was related to source documentation or another type of deviation not included in the list, select “Other.”

Specify type of deviation:
Specify the type of deviation that best describes the deviation. See the table below for information about the types of deviations.

Information for Drop-downs:

Deviation Type								Type Specify
Informed Consent								Informed consent not obtained
								Informed consent process not documented
								ICF signed outside of required timeframe
								ICF incomplete (e.g., missing signatures, dates, initials, pages, etc.)
								Incorrect ICF (e.g., not approved consent, previous version, expired version, incorrect type, etc.)
								ICF missing but consent process is documented
								Original ICF missing but copy is maintained
								Informed consent other
Lab / assessment requirements								Lab / assessment not done
								Lab / assessment outside of required time frame
								Lab / assessment other
								Subject eligibility criteria								Subject eligibility criteria not met
Subject eligibility criteria other
Serious Adverse Event reporting								SAE not reported within required timeline to sponsor
								SAE not reported within required timeline to IRB
								SAE other
IRB								Research activity prior to IRB approval
								Research activity during lapse in IRB approval
								Other IRB related
Subject visit								Out of window
								Missed visit
Other								Source documentation
								Other

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