A protocol deviation (PD) is any noncompliance with the clinical trial protocol or ICH GCP. PDs may be either on the part of the subject, the Investigator, or the study site staff. As a result of deviations, corrective actions may be developed by the site and implemented promptly.
These practices are consistent with Good Clinical Practice (ICH GCP E6) Sections:
- Compliance with Protocol, Sections 4.5.1, 4.5.2, and 4.5.3
- Quality Assurance and Quality Control, Section 5.1.1
- Noncompliance, Sections 5.20.1, and 5.20.2
An Investigator must not make any changes or deviate from this protocol, except to protect the life and physical well-being of a subject in an emergency. An Investigator shall notify the sponsor and the reviewing IRB (per local requirements) of any deviation from the investigational plan to protect the life or physical well-being of a subject in an emergency and those deviations which affect the scientific integrity of the clinical investigation within 24 hours of awareness by the Investigator.
It is the responsibility of the site Investigator to use continuous vigilance to identify deviations promptly. Protocol deviations must be sent to the reviewing IRB per their policies. The site Investigator is responsible for knowing and adhering to the reviewing IRB requirements.
Visit:
Indicate the visit in which the protocol deviation occurred. If the protocol deviation was not associated with a visit, select “Not associated with a visit.” If the protocol deviation was associated with all visits, select “All visits.”
Date of Deviation:
Report the date the protocol deviation occurred. Report date in DD/MMM/YYYY format.
Deviation Type:
Select the type of deviation (see table below). Options include: Informed consent, Lab/assessment requirement, Investigational product, Subject eligibility criteria, Adverse event reporting, IRB, Subject visit, Data quality and integrity, or Other.
Specify type of deviation:
Select the type of deviation that best describes the event (see table below). If “Other” is indicated, describe the Deviation description field below (up to 200 characters). See Table 1 below for a detailed list of types of deviations.
Specify Lab / Assessment Requirement:
This field appears only if “Specify type of deviation” is answered Lab / assessment requirement. Indicate which of the following protocol assessments were impacted by this protocol deviation.
Table 1. Deviation Types and Subcategories
Deviation Description:
Describe the protocol deviation in further detail (up to 200 characters).
Reason for Deviation:
Indicate reason for protocol deviation as site related or subject related. Review instructions for field below for examples of site versus subject related deviations.
Specify Reason:
For site related protocol deviations, specify the reason the deviation occurred. Options include:
• Staff not available
• Investigator oversight
• Laboratory error
• Other, specify
For subject related protocol deviations, specify the reason the deviation occurred. Options include:
• Subject refused
• Subject cancelled appointment
• Subject medical condition
• COVID-19 (e.g., subject not willing to visit clinic due to COVID-19 concerns)
• Other, specify
If the site or subject related deviation occurred for a reason not listed above, select “Other, specify” and further specify the reason the deviation occurred in the field below (up to 200 characters).
Specify Other Reason:
If ‘Other, specify’ was selected for the field above, further specify the reason the deviation occurred in this field (up to 200 characters).
NMDP IRB Classification of Event:
This question is required if your center relies on NMDP IRB for this study.
Indicate which of the following classifications this event was designated as by NMDP’s IRB. It is the relying institution’s investigator’s responsibility to assess whether a protocol exception should be classified as major or minor. The NMDP IRB policy on Protocol Exceptions, Deviations, and Temporary Variances is linked here.
Was this major protocol exception approved by the NMDP IRB prior to implementation:
This question is required if the NMDP IRB classification of event was reported as a Major protocol exception.
Select the appropriate response.
Date Approved:
This question is required if the NMDP IRB classification of event was reported as a Major protocol exception.
Report the date of major protocol exception approval in DD/MMM/YYYY format.
Does this event also meet the definition of an unanticipated problem involving risks to participants or others (UPs)?:
Report if the event meets the definition of an unanticipated problem involving risks to participants or others (UPs). See protocol section 8.8 UNANTICIPATED PROBLEMS for more details.
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