HRP Services
Compliance Assessments, Audits
HRP Consulting is frequently asked to assist organizations by providing an independent assessment of investigator, committee, or program compliance with regulatory or accreditation standards. Whether routine QA or for-cause, comprehensive or targeted, or an evaluation of inspection or accreditation readiness, HRP is prepared to help.
OHRP Issues Single IRB Draft Guidance
On July 1, 2022, OHRP posted a draft guidance document for public comment entitled “Use of a Single Institutional Review Board for Cooperative Research.” The draft guidance will be open for public comment until August 30, 2022. The recently posted draft guidance...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”:...