A Basic Training in Good Clinical Practice for Investigators and Ethics Review Committee Members co-organized by the Region 1 Health Research and Development Consortium (R1HRDC) and Metro Manila Health Research and Development Consortium (MMHRDC) was held on December 12-13, 2015 at the 5th Floor Function Hall of the Mariano Marcos Memorial Hospital and Medical Center (MMMH & MC), City of Batac, Ilocos Norte.
The 37 participants who attended the training are mostly Medical Practitioners, Researchers and members of Ethics Review Committee from the University of Northern Philippines (UNP), Lyceum Northwestern University (LNU), Northwestern University (NWU), Northern Christian College (NCC), Mariano Marcos State University (MMSU), Don Mariano Marcos Memorial State University (DMMMSU) and Mariano Marcos Memorial Hospital and Medical Center (MMMH&MC).
The general objective of the training is to be able to apply Good Clinical Practice (GCP) and Health Research Ethics Guidelines and Principles (HREGP) in the performance of specific research roles. The specific objective is to apply GCP and international guidelines, as well as national guidelines and regulations in the conduct of clinical research.
14 topics were discussed during the training. Dr. Marita V. Reyes, Dr. Jacinto Blas Mantaring, Dr. Lilia Valledor and Prof. Edlyn Jimenez were the main resource speakers/facilitators of the said training.
During the first day of training, Ms. Edlyn Jimenez discussed Topic #1: International Guidelines and Principles of Research Ethics, Dr. Reyes discussed Topic #2: National Guidelines and Principles, Topic #3: History and Principles of GCP and Topic #5: Role of Ethics Committee, Dr. Mantaring discussed Topic #4: Role of Investigator and Dr. Villador discussed Topic #6: Role of Sponsor and Topic #7: GCP and Audit Inspection. Exercises were given by Ms. Jimenez and Dr. Villador after all the topics were discussed.
On the second day, Dr. Mantaring discussed Topic #8: Ethical Issues in Clinical Trials, Topic #9: Ethical Issues in Observational vs. International Clinical Research and Topic #10: Vulnerability in Health Research, Dr. Valledor discussed Topic #11: SAE Reporting, Addressing Risks in Protocol Implementation and Topic #12: Conflict of Interest followed by Topic #13: Confidentiality Issues in Health Research and Topic #14: Informed Consent discussed by Ms. Edlyn Jimenez. Right after the lecture, Dr. Valledor and Ms. Jimenez administered the Workshop regarding the Research Protocol Issues followed by a post test.
The training ended with the awarding of certificates to the lecturers/speakers and participants.