Jun 4, 2019 · It provides guidance on the HHS regulations for the protection of human research subjects at 45 CFR part 46 related to institutional review board (IRB) continuing review of …

Continuing Review is the process by which the IRB re-evaluates whether a protocol is being conducted in compliance with the criteria for approval that are applied during initial review. …

With respect to continuing review, FDA’s regulations require an IRB to develop and follow written procedures for: Conducting continuing review of research at intervals appropriate to the degree...

If you want to continue working on a study beyond its expiration date, you must submit the study to the IRB for continuing review approval. The IRB re-reviews the study to determine if it is …

What is a Continuing Review? Continuing Review (CR) is the ongoing, scheduled IRB review of a previously approved non-exempt human subjects research study, at intervals appropriate to …

IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, …

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB: Must occur within 12 months of the approval date.

An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in …

Continuing Review is a federally mandated re-evaluation of an approved study that is required to be conducted at least once per year. For most new non-exempt, minimal risk, and non-FDA …

For studies regulated by the 2018 Common Rule: Except for studies determined to be exempt from IRB oversight, human subject's studies are required to undergo continuing review based …