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Compliance In Focus


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Posted by Jaime Wynbrandt on Tue, Feb 16, 2016

Compassionate Use vs. Planned Protocol Deviation - What is the Difference?

A group of us found ourselves asking this very question after a monitoring visit…what is the difference between a compassionate use subject and a subject who is enrolled in a study without meeting all the inclusion/exclusion criteria (planned protocol deviation)? In both cases the subject does not meet inclusion/exclusion criteria.

As always, we took it to the Federal Regulations/Guidances to see what they said.

Topics: Compassionate Use, Protocol Deviations, FDA

Posted by Jaime Wynbrandt on Mon, Nov 06, 2017

Planned Protocol Deviations- Should Sponsors Notify FDA?

During a routine monitoring visit of a physician-sponsored IDE study, it was noted that the site was receiving “waivers” from the Sponsor to enroll subjects who did not meet one of the anatomical exclusion criteria. A rational was provided on why the subjects were being enrolled in the study. The site submitted the planned protocol deviations to the IRB and received IRB approval prior to enrolling the subjects. The Sponsor did not seek prior approval from the FDA, but did notify them of the deviations via the Annual Progress Report (APR).

From the FDA’s perspective, did the Sponsor do enough?

Topics: Protocol Deviations, FDA, Sponsor, Physician-Sponsored IDE Study, Clinical Monitoring

Posted by Jacqui Lingler on Wed, Mar 04, 2015

Protocol Deviations and IRB Policies - What a Monitor Needs to Know

Deviations from the protocol, or non-compliances, are inevitable across a multi-centered study. Some deviations can be prevented by the investigational site study staff, such as in exclusionary criteria noted in the medical history. Other deviations, such as missed visits due to the subject’s schedule, can not be avoided. According to 21 CFR 812.46(a), it is the responsibility of the sponsor to ensure that the selected investigators are compliant with any conditions of approval of the reviewing IRB. The investigator, according to 21 CRF 812.110 (b), is responsible for conducting the trial in compliance with the conditions of approval of the reviewing IRB. Additionally, investigators are responsible for maintaining records relating to deviations, including dates of and reasons for, according to 21 CFR 812.140(a)(4).

Topics: Protocol Deviations, IRB Policies, Clinical Monitoring

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