JDB电子研究质素保证计划
博士
- Increased understanding of the regulations that guide research projects and procedures.
- Increased communication concerning Federal regulations and University policies.
- Access to an individual to clarify the Federal regulations and University policies.
Additional Information
During the study, the JDB电子研究质素保证计划 can work with the study team in doing an informal review to check for compliance. Once completed, any findings are reviewed with the study team.
The JDB电子研究质素保证计划 will also conduct routine post-approval reviews of research or research activities at Drexel University. These internal reviews are intended to help investigators assess compliance with all applicable federal and state laws, regulations, institutional policies, and guidelines.
In addition, a directed or for-cause review may be conducted as requested by the Institutional Official, IRB, IACUC, or other regulatory office. Refer to the procedures: ORI-601 Research Quality Assurance Reviews found in the ORI Compliance Catalog for more information on quality assurance reviews.
An inspection, in the context of clinical research, involves a thorough examination of the research processes, documentation, and compliance with applicable laws and regulations. These inspections are conducted by agencies such as the Food and Drug Administration (FDA), Department of Justice (DOJ), National Institutes of Health (NIH), Drug Enforcement Administration (DEA), European Medicines Agency (EMA), Health Canada, and other regulatory bodies.
The JDB电子研究质素保证计划 can assist with agency inspections, including inspection preparation for personnel, documentation review and organization, taking notes during the inspection, and assisting with responses at the end of the inspection.
If you are notified of any inspection, please email Marisa Corbett at mjc535@drexel.edu.
The JDB电子研究质素保证计划 can provide support to investigators during sponsor-conducted independent audits, which are distinct from routine monitoring visits. This support includes evaluating compliance with the study protocol, Standard Operating Procedures (SOPs), ICH E6 R2 Good Clinical Practices, ICH E6 R3 Good Clinical Practices [PDF] (released January 6, 2025), and any applicable regulatory requirements.
The JDB电子研究质素保证计划 can assist in organizing necessary documentation, preparing for the audit, and addressing any findings or recommendations from the sponsor to ensure the study meets all required standards.
