GMP News - Pharmaceutical Development / Clinical Trials / GCP

A new Q&A at EMA´s Good clinical practice (GCP) website addresses how sponsors can demonstrate oversight for those activities that are delegated by a written contract.

The EU Commission has supplemented the area of clinical trials with "Recommendations on decentralized elements in clinical trials". The paper deals with procedures that, due to new approaches and advanced technical possibilities, can now take place outside study centers.

In February, the FDA published a guidance document entitled "Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products". This provides recommendations for the sponsors and monitors of clinical trials.

EMA's Query Management Working Group prepared a document to address the main questions received from sponsors about CTIS and the Clinical Trials Regulation.

The European Commission, EMA and the Heads of Medicines Agency (HMA) prepared a questions and answers document on data protection. The Q&A document has been created to provide guidance to CTIS users on how to protect personal data and commercially confidential information (CCI) in CTIS.

The European Commission published an updated Version 6.3 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation. The revised version includes a new Annex with information on where sponsors can find national requirements.

The updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. The update includes a new Q&A regarding information about vaccine reporting.