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EMA Updates GCP Guide To Clarify Sponsor Role In Contracting For Trial-Related Tasks

 
• By Vibha Sharma

Based on the trial design and setting, the European Medicines Agency says the sponsor may support the investigator by identifying or contracting service providers or personnel to be involved directly in the conduct of the clinical trial.

African doctor wear headset consult female black patient make online webcam video call on laptop screen. Telemedicine videoconference remote computer app virtual meeting. Over shoulder videocall view.
The investigator is ultimately responsible for any tasks involving trial-related medical decisions • Source: Shutterstock

The European Medicines Agency has updated its good clinical practice (GCP) guidance to support changing trends in the conduct of clinical trials, such as the increasing tendency of sponsors of decentralized clinical trials (DCTs) to get involved in contracting service providers for tasks that traditionally fall within the remit of the trial investigator.

The GCP Q&A has also been updated to address the use of productivity software in clinical trials, for example, to support operational processes and to record, track and evaluate events...

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