Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB IRB policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...
The flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow ...
Researchers may use the "Protocol Template" below to type out and draft their protocol submission. Final versions of the protocols must be submitted via SPARCS. PROTOCOL Template All protocols are ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...
eProtocol is the Key Solutions software tool used to manage the life of a protocol. For investigators, the eProtocol system allows for the creation of a protocol and the routing of the protocol to the ...
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