Question

According to the ICH E6 guidance on good clinical practices, discuss the role and responsibilities of all stakeholders involved in clinical trials for the development of medicinal products for human use.

Answer 1

Ich E6 recognises the sponsor routinely use electronic system for trial data. All the stakeholders are made aware of the importance of compliance with good clinical practice guidelines in clinical trials. Investigators need to diligently follow GCP for effectively and safely conducting trials in a properly designed manner to produce accurate data and medical knowledge. GCP guidelines ensure clinical data generated are verifiable, accurate and Reproducible during a trial.