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OFFICE OF REGULATORY AFFAIRS

ORA was created out of a necessity to standardize and centralize regulatory issues across all clinical trials conducted within the unit as a result of the ever growing number of trials and the demand for such services. Now as an independent department of the Walter Reed Project-Kisumu, the Office of Regulatory Affairs has a secretariat staffed with a full time Director and an assistant.  

The department is staffed with 7 Clinical Research Coordinators at different levels of training including 2 ACRP certified clinical research coordinators, and 8 members of the quality control and records department. 

Functions: The Office of Regulatory Affairs manages efforts to support and coordinate regulatory affairs in the conduct of human subjects’ research within the Unit. The office spear heads the Planning, coordination, and internal monitoring of clinical trials to ensure compliance with Institutional Review Board and U.S. Food and Drug Administration regulations; and thus serving as a resource for clinical investigators, to ensure the safety of volunteers in clinical trials.

Specific duties include:

  • Provision of regulatory affairs support to the Clinical Trial Operations including development of Standard Operating Procedures.
  • Ensuring regulatory compliance during protocol development and review
  • Providing or assisting in the compliance of regulatory strategy  and quality control plan for each clinical trial conducted
  • Plan, compile and file regulatory submissions
  • Interact with regulatory and government agencies and provide updates when required
  • Assist investigators to prepare written study summary reports of adequate quality at study conclusion

CRC Training: This program prepares candidates by the globally accepted guidelines and practices necessary to conduct research that is of the highest attainable ethical, scientific, and safety standards. The CRC training enables the trainees to perform a variety of clinical research activities while protecting human research subjects and advancing valid clinical research. Through discussions, independent studies, workshops,  hands- on practical experience and seminars, students will gain the required knowledge and skills to participate effectively and efficiently in planning, conducting, and coordinating clinical trials. Trainees are also exposed to the procedures of protocol submissions and the IRB process culminating in the CRC certification

  


 
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