GCP Blog

Clinical trial updates 2021

As we move away from 2020 and start looking forward into a more positive 2021, this blog looks at some of the important changes and...

What happens when a trial patient needs to claim compensation for a Serious Adverse Reaction?

How many of us have been in a situation where we have seen a patient genuinely injured by their participation in a clinical trial? In the...

IIT Sponsor responsibilities in GCP

This post and additional posts over the coming week will focus on the Sponsor responsibilities for sites conducting their own...

Investigator responsibilities in GCP part 6

This post continues with investigator responsibilities in GCP 4.2.5: "The Investigator is responsible for supervising any individual or...

Investigator responsibilities in GCP part 5

This post continues with Investigator responsibilities in GCP 4.2.4: "The Investigator should ensure that all persons assisting with the...

Investigator responsibilities in GCP part 4

This post continues with Investigator responsibilities in GCP 4.2.3: The Investigator should have available an adequate number of...

Investigator Responsibilities in GCP part 3

This post continues further with Investigator responsibilities and this week focuses on GCP 4.2.2 The Investigator should have sufficient...

Investigator responsibilities in GCP part 2

This post continues to expand on Investigator responsibilities and this week focuses on GCP 4.1.3 and 4.1.5... "The Investigator should...

Investigator responsibilities in GCP part 1

Investigator responsibilities were significantly expanded upon in the 2016 E6 R2 GCP updates but how do you ensure your site is...