DSpace Collection: https://hdl.handle.net/20.500.14356/2540 2026-04-15T23:57:37Z Safety Reporting in Clinical Trials https://hdl.handle.net/20.500.14356/2544 Title: Safety Reporting in Clinical Trials Authors: Porasuphatana, Supatra Abstract: Drug Development: Regulatory Reviews Description: Presentation 2024-01-01T00:00:00Z Protocol Amendment Decision: IRB's Role https://hdl.handle.net/20.500.14356/2543 Title: Protocol Amendment Decision: IRB's Role Authors: Chatsiricharoenkul, Somruedee Description: Presentation. 2024-01-01T00:00:00Z Post Approval Continuing Processes: Site Visit https://hdl.handle.net/20.500.14356/2542 Title: Post Approval Continuing Processes: Site Visit Authors: Prayoonwiwat, Naraporn; Bunsi, Adun Abstract: NA Description: Presentation 2024-01-01T00:00:00Z Conducting Site Visits https://hdl.handle.net/20.500.14356/2541 Title: Conducting Site Visits Authors: Jimeno, Cecilia A. Abstract: Outline of Discussion What is a site visit by an REC? Reasons for RECs to do site visits & criteria for selection of sites Procedures involved in the site visit: composition, preparation, conduct, reporting Description: Presentation 2024-01-01T00:00:00Z