Regulatory Affairs

The IDRC Regulatory Affairs Department is responsible for ensuring that all research activities conducted by IDRC are in compliance with Good Clinical Practice (GCP) and guidelines set by the national and international regulatory organizations. The need for a regulatory core for the oversight of research projects and activities was recognized and the department was started in 2009. The IDRC Regulatory Affairs Department is headed by Dr. Bridget Nzarubara and includes three Regulatory Officers, Ms. Faith Kagoya, Ms. Linda Nassaka and Ms. Lakiyo Mary Goretti based in Kampala, Mbarara and Tororo respectively. The regulatory office has oversight of over 15 major studies and sub-studies. The department aims to have a qualified team dedicated to maintaining high scientific standards for the research results, and for the safety, integrity and respect for the patients and volunteers involved in research. Activities include:

• Staff training in GCP, GCLP, protocol specific and informed consent procedures.
• Provide support to new collaboration investigators.
• Maintain timely, ongoing communication with the Ugandan IRB officials, study teams and investigators from collaborating institutions.
• Ensuring and documenting qualified personnel and maintain, in a confidential manner, up-to-date personnel records and documents.

Regulatory and Affairs Department Staff

• Conducting site visits, ensuring the on-site team is working in accordance to GCP.
• Help to identify, report and problem solve at the different IDRC research sites in Uganda.
• Internal monitoring and planning of studies.
• Work with investigators in preparation and submission of study related documents to the ethics review board, follow-up on approvals of initial applications, protocol modifications and annual renewals from the IRBs.
• Track study submissions, follow-up approvals and annual reviews from the regulatory organizations.
• Maintenance of study essential and source documents.
• Work with investigators to identify and report serious adverse events and violations to the ethics committee.
• Prepare management summary reports, identify problem areas and document corrective action plans.
• Product storage, handling and accountability.
• Assist the lab with specimen storage, documentation and shipment.