Consultation Responses

Responses submitted on behalf of our members

The UKCRC Registered CTU Network responds to a range of national and international consultations on behalf of its members. Our submissions have been used to inform changes in policy in a number of areas. We also provide input via direct meetings with policy makers.

Click on the headings below to see more about some of the key consultations we have responded to in recent years.

International

WMA consultation on changes to the Declaration of Helsinki (Phase 1) [Issued February 2024] – To find out more about the Network’s response to this consultation, please email the Secretariat on regctus@leeds.ac.uk.

WHO guidance for best practices for clinical trials [Issued July 2023] – To find out more about the Network’s response to this consultation, please email the Secretariat on regctus@leeds.ac.uk.

EMA consultation on draft ICH E6 (R3) Guideline on good clinical practice (GCP) [Issued February 2023] – To find out more about the Network’s response to this consultation, please email the Secretariat on regctus@leeds.ac.uk.

EMA consultation on points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials [Issued May 2020] – To find out more about the Network’s response to this consultation, please email the Secretariat on regctus@leeds.ac.uk.

National

MHRA consultation on proposals for legislative changes for clinical trials [Issued January 2022] – To find out more about the Network’s response to this consultation, please email the Secretariat on regctus@leeds.ac.uk.

MHRA consultation on the future regulation of medical devices in the United Kingdom [Issued September 2021] – To find out more about the Network’s response to this consultation, please email the Secretariat on regctus@leeds.ac.uk.

MHRA draft guidance on randomised controlled trials generating real-world evidence to support regulatory decisions [Issued October 2020] – To find out more about the Network’s response to this consultation, please email the Secretariat on regctus@leeds.ac.uk.

Universities UK Concordat To Support Research Integrity: 2019 consultation on revised Concordat [Issued April 2019] – Network Response

National Data Guardian for Health and Social Care: a consultation about priorities [Issued February 2019] – Network Response

NHS England consultation covering changes to simplify arrangements for research in the NHS and associated changes to the terms of the NHS Standard Contract [Issued February 2018] – Network Response

NIHR
Cancer Research UK
Health & Social Care Research Wales
Versus Arthritis
UK Trial Managers' Network
MRC-NIHR Trials Methodology Research Partnership
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