Good Clinical Practices

Module 1 – Good Clinical Practice

Regxia's training webinar on Good Clinical Practice (GCP) contains eight interactive and visually appealing sessions of up to one hour in length. Unlike traditional online GCP training webinars, Regxia strives to provide high learner interactivity with thought provoking checkpoints, which work to create a stimulating learning experience.

GCP Session 1: Introducing Good Clinical Practice

Session 1 delivers a pleasant introduction to GCP, enabling the learner to walk away with a strong beginning knowledge of the purpose and importance of GCP.
Course Module 1 Session 1

GCP Session 2: Institutional Review Board (IRB) & Independent Ethics Committee (IEC)

Session 2 works to create an understanding of the IRB and IEC’s roles in clinical practice.
Course Module 1 Session 2

GCP Session 3: Investigator

Session 3 provides an understanding of the roles, responsibilities, and rights of the investigator and how they relate to the IRB/IEC, Sponsor and most importantly the trial subjects.
Course Module 1 Session 3

GCP Session 4: Sponsor

Session 4 delivers insight on the roles and responsibilities of the sponsor and how they too relate to the other important bodies noted in GCP.
Course Module 1 Session 4

GCP Session 5: Monitoring

Session 5 aims to educate learners on how compliance with GCP is determined and what is required should non-compliance be determined.
Course Module 1 Session 5

GCP Session 6: Clinical Trial Design Protocol & Amendments

Session 6 presents information on what is expected to be included when designing a Protocol and the processes for its finalization and lifecycle management.
Course Module 1 Session 6

GCP Session 7: Investigator’s Brochure

Session 7 provides an introduction to the Investigator’s Brochure and then allows the learner to explore it more thoroughly.
Course Module 1 Session 7

GCP Session 8: Essential Documents

Session 8 conveys a timeline of the essential documents and outlines whose responsibility it is to complete, submit and update these documents.
Course Module 1 Session 8

Upon successful completion of the GCP Training Module, the learner will be awarded a certificate identifying their ability to apply GCP during their conduct of clinical trials, as well as to understand and identify the roles of the different parties involved in research.

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