For this week’s writing exercise, read the attached ICH E6 guidance on good clinical practices and write a 2-4
double spaced pages essay discussing the role and responsibilities of all stakeholders (Sponsors, CROs,
Investigative Sites) involved in clinical trials for the development of medicinal products for human use.
Please note that for the first time in nearly 20 years, E6 has been revised to include additional stakeholder
accountabilities. See the attached revision of the ICH E6, Revision 2, Integrated Addendum that highlights
these key changes.
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
https://database.ich.org/sites/default/files/E6_R2_Step_4_Presentation_0.pdf
https://www.linkedin.com/pulse/fda-ich-gcp-e6-r2-operational-guideline-requirements-cros-usala-md?
articleId=6673986997641629696
Questions 2 (1 page)
In your own words, discuss the validity of the involvement of Contract Research Organizations in clinical trials.
Is this a good system, or is there a better way to have oversight?