Time

Topic

Practical Exercises / Corner Discussions /
Group Work

8.00 - 9.00 AM

Registration

8.50 – 9.00 AM

Opening & Introduction

9.00 – 9.55 AM

History of Clinical Trial Legislation
CFR, Decl. of Helsinki, ICH, Regulatory Bodies, Summary

-

9.55 – 10:10 AM

Coffee Break

10:10 – 11.50 AM

ICH – GCP : Overview, Roles and Responsibilities, EC/IRB, Investigator, Sponsor, Study Protocol and Amendments, Investigator Brochure, Summary

Corner Discussion Related to Protocol Violations

11.50 – 1.00 PM

Lunch Break

1.00 – 1.30 PM

Advertisement and Subject Recruitment

Practical Exercise: Material Review

1.30 – 2.15 PM

Informed Consent Process

Practical Exercise: Role Play on Consenting a Patient

2.15 – 3.00 PM

Safety in Clinical Trials

Corner Discussion Related to Safety Case Assessments

3.00 – 3.15 PM

Coffee Break

3.15 – 3.40 PM

Investigational Product Handling at Site

-

3.40 – 4.20 PM

Essential Documents, Documentation and Archiving

Group Work: Electronic Documents as Medical Source

4.20 – 4.30 PM

Discussion & Closing Ceremony