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Q1. If the intention within the protocol is to collect AEs from the time of ICF signed until 30 post final dose of study drug, what is the expectation for screen failure subjects? Is CRF collection required for all subjects who signed Informed Consents, including screen failures? Can the protocol state otherwise?
Q2. Are there regulatory requirements for screen failure data collection?
Here is what we have said before about records necessary to be maintained for individuals who fail screening:
I am not aware of any FDA guidance that specifically addresses what information an investigator should maintain on individuals who fail screening. The ICH E6 Good Clinical Practice Consolidated Guidance, available at www.fda.gov/cder/guidance/959fnl.pdf, an FDA endorsed guidance document, includes screening logs in the list of essential documents to permit evaluation of the conduct of a trial (see section 8.3.20); but FDA regulations do not specifically identify such logs. Please note that guidance is not legally binding on the agency or industry but it does represent an approach that is compatible with FDA regulations. If screening logs are used, they are considered study related documents and need to be maintained in accordance with 21 CFR 312.62(c) for drug and biologic studies and 21 CFR 812.140(d) for device studies.
In general, the information maintained on individuals screened for a study should be sufficient to demonstrate that the study screening was appropriately conducted per the investigational plan. I believe the information needed to demonstrate compliance with the investigational plan may depend on the specific study. If screening is based solely on procedures and tests that are the standard of care for such patients (that is, would be performed whether or not study entry was contemplated, such as for diagnosis or treatment of a disease or medical condition), then specific records on screen failures may not be needed unless the sponsor requires such records (in which case you should contact the study sponsor to determine the minimum information needed). In the case where screening involves procedures/tests that are performed solely to determine study eligibility, however, I believe records need to be maintained because these activities are directly related to the research. At a minimum, the records should include signed and dated consent forms for the screening procedures/tests, the results of those procedures/tests and any other documentation, such as physician's or nurse's notes, documenting the reason for screening failure.
Of course, for individuals who pass screening, records demonstrating that the screening criteria are met would be part of the case histories required to be maintained for the study. Please refer to 21 CFR 312.62 for drug and biologic studies and 21 CFR 812.140(a) for device studies for the regulatory requirements.
I'll try to get a written response for the other question out to you in the next day or so.
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