On 6/21/16, the National Institutes of Health (NIH) issued a final policy to streamline IRB review. Expectations are that a single IRB (sIRB) will be used for all non-exempt multi-site research at U.S. sites for research funded by NIH. There may be exceptions only if...
A Notice of Proposed Rulemaking (NPRM) released 8 Sep 2015 outlines revisions to the Common Rule (45 CFR 46 subpart A) meant to modernize, strengthen, and make it more effective. The most significant changes to the Common Rule proposed in the NPRM are as follows:...
In order to present related information to a clinical study and acquire and document informed consent, electronic systems and processes such as text, audio, and graphics are increasingly being employed. According to FDA per their new draft guidance, this is referred...
We are pleased to announce our recent updates to the Pearl IRB website. In the Resources section, you will find new and revised forms to serve you in the IRB submission process. Some of these changes include: Updated submission guide and policies, which we suggest all...
Cameron from Total Biopharma introduces an interesting artical about how clinical trials are being designed and executed to fit the changing needs of the industry. With costs and complexity increasing in clinical reseach, Total Biopharma offers their own A-Z...
