HRP Services
Program Evaluation
Many organizations recognize the value in having an external entity conduct a comprehensive unbiased review of their research oversight programs and committees to evaluate compliance, structure, effectiveness, efficiency, processes, accreditation readiness, staffing, or any number of factors. Program evaluations help organizations identify and understand strengths, weaknesses, and areas of potential risk, and where to best focus their attention to improve or enhance their programs.
Whatever the purpose, HRP Consulting Group can conduct a comprehensive, customized program evaluation to help you achieve your goals.
OHRP Issues Single IRB Draft Guidance
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...
IND Safety Reports and IRBs
HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”:...