Interactive Training in Applied GCP for Investigators, Researchers & Clinical Staff

28 February
Ethical Principles

1.00pm Welcome and Introduction
1.05pm Ethical Principles in the Declaration of Helsinki – Q&A
1.30pm ICH-E6(R2): Good Clinical Practice Principles and Guideline – Content, Questions & Answers
2.15pm The Informed Consent – Process, Q&A
2.35pm Ethical Aspects in Recruitment – Q&A
3.00pm End of Part 1

2 March (optional)
The New Clinical Trial Regulation

1.00pm Welcome and Introduction
1.05pm Introduction to the new in the Clinical Trial Regulation 536/2014 (CTR)? Q&A
2.15pm CTR Aspects of Particular Relevance to Investigators and Academic Clinical Trials – Q&A
3.00pm End of Part 2

7 March
Principal Investigators’ Responsibilities for a Clinical Trial at His/Her Site

1.00pm Welcome and Introduction
1.05pm Set-up of a Clinical Trial at the Site – Q&A
1.30pm Compliance in Document Management – Q&A
2.20pm Critical Elements in Conducting Clinical Trials – Q&A
2.35pm PI’s responsibilities in Safety Reporting in Clinical Trials – Q&A
3.00pm End of Part 3

9 March
Risk-adapted Quality Management in Clinical Trials

1.00pm Welcome and Introduction
1.05pm Risk-adapted Management of Clinical Trials – Q&A
1.45pm Exercise: Critical Review of GCP Conditions Presented in a Publication
2.20pm Multiple Choice Test
3.00pm End of Part 4

DATA PRIVACY

Read more about the “Data Protection Notice: processing of personal data in the scope of events’ management”.