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Egypt’s First Decentralized Trials Guideline Addresses Using Off-Site Nurses

 
• By Vibha Sharma

Drawing references from the EU and US guidelines for decentralized clinical trials, the Egyptian FDA has framed draft requirements that sponsors should consider when planning to use off-site nurses in their drug and medical device studies.

Young caregiver helping senior woman walking. Nurse assisting her old woman patient at nursing home. Senior woman with walking stick being helped by nurse at home.
Egypt has developed criteria and qualifications for off-site nurses • Source: Shutterstock

The Egyptian Drug Authority (EDA) has issued its first ever guideline on decentralized clinical trials (DCTs), focusing on the benefits and challenges of using off-site or remote nursing services in interventional studies for drugs, biologics and medical devices.

The draft EDA guideline, which is out for public consultation until 25 May, refers to, and builds upon, recent guidelines by the US and EU regulators on DCTs, which allow...

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