Understanding ICH GCP E6 (R3) Annex 2

Understanding ICH GCP E6 (R3) Annex 2

The next phase of the ICH GCP E6 (R3) modernisation is on its way, and Annex 2 is set to reshape how sponsors, CROs and investigators approach decentralised, pragmatic, and real-world data-enabled trials. While Annex 1 covers traditional interventional studies, Annex...
Why is Informed Consent Crucial in Clinical Trials?

Why is Informed Consent Crucial in Clinical Trials?

Just imagine being presented with an opportunity to participate in a clinical trial without knowing the potential side effects, the purpose of the study, or how your data will be used! It would be a difficult decision to make, right? Informed consent aims to eliminate...