Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials
Date: January 26, 2022
Dear Colleague,
We have just launched our 8-week public consultation on proposals for legislative changes for clinical trials.
We want to streamline clinical trial approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and promote patient and public involvement in clinical trials.
We would like to hear from clinical trial participants, researchers, developers, manufacturers, sponsors, investigators, healthcare professionals and the wider public to help shape improvements to the legislation for clinical trials.
You can read more about our proposals in our Press release and consultation document.
Please do share this email and the social media links below with your networks and contacts so that we can get the broadest possible response.
The consultation will close at 11pm on Monday, 14 March 2022.
Thank you for your support.
The Medicines and Healthcare products Regulatory Agency
https://www.gov.uk/government/consultations/consultation-on-proposals-for-legislative-changes-for-clinical-trials
Explore More News

New MHRA Guidance
The MHRA have published new guidance on ‘Software and Artificial Intelligence (AI) as a . . .
Read More

FDA Guidance for Industry
The FDA has issued a final guidance to provide information on risk-based approaches to . . .
Read More

Guideline on computerised systems and electronic data in clinical trials
The European Medicines Agency (EMA) have published the new guidelines on computerised . . .
Read More

Welcome IROS – Insights Research Organization & Solutions as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome IROS – Insights . . .
Read More

Recommendation paper on decentralised elements in clinical trials
Following their meeting on 4 Oct, the EMA/HTAs and EC have published a recommendation . . .
Read More

Welcome George Clinical as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome George Clinical . . .
Read More

Welcome Clinion as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome Clinion as a . . .
Read More

Welcome ClinoSol Research as a new corporate member
The ACDM: Association for Clinical Data Management is delighted to welcome ClinoSol . . .
Read More

CTU DMEG Update
The CTU DMEG has been actively discussing common problems that data managers face in . . .
Read More

ICH E8 (R1) General Considerations for Clinical Studies Impact on Data Management
The ACDM Regulatory Considerations have reviewed the Revision 1 to the ICH E8 Guidelines . . .
Read More

ACDM Comments on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for Industry, Investigators, and Other Stakeholders; Availability”
https://acdmglobal.org/wp-content/uploads/2022/04/ACDM_FDA_DHT.pdf
Read More

Have your say – MHRA’s public consultation on proposals for legislative changes for clinical trials
Dear Colleague,
We have just launched our 8-week public consultation on proposals for . . .
Read More