The flowchart and steps below outlines the best practice for ... Protocol (Grant application, sponsor protocol, study group protocol) Category A or B devices? Complete a Clinical Billing Review (CBR) ...

The Draft Guidance defines “protocol deviation” as “any change, divergence, or departure from the study design or procedures defined in the protocol.” In contrast, an “important protocol ...

For example, an investigator’s failure to perform a protocol-required test being discovered by the study monitor during a routine monitoring visit would be a protocol deviation. It may also ...

The FDA has cleared Brainstorm to initiate a Phase 3b clinical trial testing NurOwn (debamestrocel) in people with moderate ...

The lack of a mechanism to measure the workload involved in a clinical trials protocol was identified and confirmed by a literature review. To collect information on how Ontario sites were assessing ...