Should this be brought up to the IRB to determine? Answer: The protocol should be followed as written. If there are discrepancies in the protocol, this should be brought to the attention of the sponsor and the IRB. Additionally, the sponsor of the study can contact the FDA regulatory project manager of the investigational new drug to seek advice on how to handle this situation.
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Some suggested definitions are as follows: Food and drug administration Compliance Program Guidance Manual. Norman M. Footnotes Source of Support: Nil. Support Center Support Center. External link. Please review our privacy policy. The requirements in paragraph a 1 of this section regarding FDA approval of a supplement do not apply to changes to clinical protocols that do not affect:.
A The validity of the data or information resulting from the completion of the approved protocol, or the relationship of likely patient risk to benefit relied upon to approve the protocol;. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment s should be submitted:.
To sign up for updates or to access your subscriber preferences, please enter your contact information below. A-Z Index. Attachment C: Recommendation on Protocol Deviations. Focus of the Recommendation In virtually every research study departures occur from the procedures set forth in the IRB-approved protocol. This recommendation specifically addresses three types of deviations: Deviations that occur because an investigator, research staff or other party involved in the conduct of research intentionally decides to deviate from the approved protocol.
Deviations from the protocol that are identified before they occur, but cannot be prevented. Deviations from the protocol that are discovered after they occur. Both of these activities are outside of the scope of this recommendation. An investigator shall prepare and submit the following complete, accurate, and timely reports: 4 Deviations from the investigational plan. Determine whether changes to the protocol were: Documented by an amendment, dated, and maintained with the protocol; Reported to the sponsor when initiated by the clinical investigator ; and Approved by the IRB and FDA if applicable before implementation except when necessary to eliminate apparent immediate hazard s to human subjects.
Intentional Protocol Deviations The first focus of this recommendation is deviations that occur because an investigator, research staff or other party involved in the conduct of research intentionally decides to deviate from the approved protocol. Examples of such intentional protocol deviations include the following types of cases: Lab criteria: One test is out of range for a benign reason increased alkaline phosphatase, LDH or SGOT in a runner, or increased bilirubin in a person with Gilbert Syndrome.
The investigator decides to enroll the subject despite the out-of-range lab criteria. Age criteria: The criteria includes an age requirement of years of age, but a potential subject turned 61 a week before screening.
The investigator decides to enroll the subject despite being outside of the age range. Payment: The protocol specifies that subjects will be paid twenty dollars per visit. To compensate for higher expenses, the investigator decides to pay certain subjects more than other subjects. Timing of study visit: At the time of enrollment, the investigator realizes that due to a planned vacation the subject will miss one out of 12 regularly scheduled two-week study visits.
The investigator decides to enroll the subject despite this knowledge. Timing of washout: A planned vacation interferes with a washout period. Shortening the wash-out period from 14 to 12 days will allow the subject to be enrolled. The investigator decides to enroll the subject with a day washout. Pre-treatment exceeded: Protocol entry criteria specify that only a certain amount of pre-treatment of disease is acceptable.
A potential subject has exceeded it to a minimal extent. The investigator enrolls the subject despite knowledge of the extent of the pre-treatment. Changes to survey instrument: In a behavioral study utilizing a questionnaire, the investigator realizes that two of the questions would work better in reverse order. The investigator re-orders the questions without IRB approval.
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