Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

UK Explains Dos And Don’ts Of Remote Clinical Trial Monitoring

Much-Awaited Guideline Outlines Critical Functionalities For EHR Systems

Executive Summary

Updated UK guidance describes the factors that clinical trial sponsors and investigator sites must consider when giving appointed representatives direct access to the electronic health records of participants in clinical trials to check source data.

You may also be interested in...



Canada Seeks To Make Decentralized Trials More Practical For Sponsors

By formally adopting a modernized definition of a clinical trial site, Health Canada is hoping to provide greater flexibility to sponsors who want to incorporate decentralized elements in their trials.

EU Makes Only Limited Use Of Remote Clinical Trial Monitoring

While regulators worldwide are opening up to the possibility of remote verification of source data from clinical trial sites because of COVID-19 restrictions, this approach is finding less favor in the EU, mainly because of strict data protection rules.

UK Warns Against Printing Out EHRs For Clinical Trial Monitors

New UK guidance explains how clinical trial sponsors and investigator sites can ensure that trial monitors securely process data in electronic health record systems that do not have a restricted access functionality.

Topics

Latest News
UsernamePublicRestriction

Register

PS144924

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel