Training Course

Good Clinical Practice

November 10-14, 2008

 

Course Description

This training course covers an orientation on the standards, ethics, tools, procedures and guidelines for Good Clinical Practice. The training will be conducted using didactic, practical and experiential learning exercises in the discussion of the various topics as well as in the learning application. The exercises will cover applications, issues, problems and violations of Good Clinical Practice Guidelines. The workshop will also harness the cooperative spirit and team values of the different players involved in clinical trials. This workshop hopes to advocate public safety through vigilant reporting of adverse events even beyond the clinical trial periods.

 

 

Course Objectives      

 At the end of the course the participants should be able to:

 

1. Explain the major roles and responsibilities of the Sponsor, the Investigator and the Monitor in clinical trials;
2. Discuss the major provisions in the conduct of clinical trials from the perspective of international and national standards;
3. Explain the different standards and procedures of Good Clinical Practice for each phase of the clinical trial;
4. Appreciate eligibility requirements for selection of sites for clinical trials;
5. Critic informed consent forms report forms in consonance with Good Clinical Practice;
6. Demonstrate the proper way of administering an informed consent form;
7. Discuss the duties/responsibilities of Ethics Committees; and
8. Enhance the team work and values of the GCP – clinical trial team.
   

 

 

Contact Person

Dr. Ofelia P. Saniel
Chair, DEBs
Tel no. 524-7118 and
Telefax no. 525-42.39om