TransCelerate certified Basic GCP Course


Good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data. This short course aims to provide the researcher with the basic principles of GCP and how these principles can be applied practically in the research setting. The course is aimed at all those involved in clinical research.

Course summary: This course is based on the international E6 ICH E6 (R2) Good Clinical Practice regulations and it’s a complete training solution for all individuals that need to acquire GCP knowledge. Also, this course is TransCelerate certified and after successful finishing this course you will earn Basic GCP certified diploma. Course contains 11 audio/video presentations where is described in details everything about Good Clinical Practice.

Topics for this course:

History and Principles of GCP    00:18:44
Regulatory Requirements – EU, FDA    00:18:09
Informed Consent   00:12:48
Ethics Committees    00:14:13
Sponsor’s responsibilities   00:17:01
PI’s responsibilities    00:07:41
Essential Documents     16:29
Monitoring     00:16:23
Source Data Verification    00:15:05
Drug Accountability    00:08:10
Safety reporting    00:06:38
Final test   20 questions, 40 min
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