Informed Consent Creation, Review & Maintenance

Informed consent creation, review, and approval of site and IRB changes are important steps to enrollment readiness. With years of experience in dealing with local and central IRBs, BMA will help create and author consents. We will then work with your protocol and study requirements, regulatory agency guidelines, and sites to review and finalize these critical forms.

BMA will also review and approve Sponsor or site driven changes after the initial IRB approval, as well as annual/semi-annual IRB re-approvals, to ensure that all language matches the most recent version of the model consent and is still acceptable to you.

With BMA’s quality check processes and procedures, you can be assured that final, approved consent forms contain all required regulatory and protocol elements and that potential subjects have consents that give them the necessary information to truly make informed decisions.

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