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Get resources and best practices for clinical research reporting requirements including common rule, FWA, ALCOA, and more.
agreement and this supplemental SOP including IRB specific reporting mechanisms. Advarra IRB requirements and VHA requirements in VHA Handbook 1058.01Dec 20, 2019 — Advarra has updated its IRB Handbook for Investigators, Institutions added reporting requirements to AAHRPP; and an updated resource for
Per regulations, Advarra’s IRB can provide expedited review for: Research that presents no more than minimal risk. These categories are listed in OHRP Guidance;
Dec 11, 2019 — Protocol deviations or violations, such as a participant neglecting to initial a page of the ICF or failing to return a symptom diary, are not
Mar 16, 2020 — Protocol deviations do not need to be reported to Advarra unless they impose an increase in the risk of harm to participants or adversely affect
Dec 14, 2018 — At Advarra, when the IRB receives SAEs or safety reports that do not meet the UAP criteria (as defined by the above FDA guidance), the
Using technology, we create smarter and faster workflows while maintaining the highest standards of transparency and quality. Speed: Reviews of all submission
Protocol deviations do not need to be reported to Advarra unless they impose an increase in the risk of harm to participants or adversely affect the integrity
Dec 4, 2019 — Consistent with other reportable events, Advarra expects noncompliance reports be submitted as soon as possible, no later than 2 weeks or 10

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