A recurring appointment of our blog: we see below the main regulatory updates in the clinical field, published and made effective from November 2020.
AIFA: publication of documentation and ways to harmonise clinical trials start-up processes (MD related)
EMA: clarification regarding the responsibilities of Sponsor and CRO in the management of a clinical trial
We communicate the update by EMA of the internet page “Q&A: Good clinical practice (GCP)”. In particular, the November 2020 update concerns question 14 of the “GCP matters” section: “14. Does the sponsor of a clinical trial have the right to audit the manufacturer of the IMP even if the manufacturer has been subcontracted by a CRO involved in a clinical trial?”. The application clarifies that the sponsor, as responsible for the quality of the IMP and the implementation of the Quality Management System, is authorized to audit the manufacturer even when certain services have been subcontracted to a CRO.
In addition, we also note the publication by EMA of the template/form: “Day 80 assessment report – Clinical template with guidance rev.02.20”.
FDA: publication of a guidance document that aims to support the sponsor in enlisting those patient populations usually underrepresented in clinical trials.