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Consultation Responses & Policy Statements

The UKCRC Registered Clinical Trials Units has responded to a number of key consultations, below you will find submitted responses:


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


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


European Medicines Agency (EMA) consultation on the guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice (EMA/202679/2018) [Issued August 2018]


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]


European Medicines Agency (EMA) consultation on the guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol' (EMA/430909/2016) [Issued August 2017]

European Medicines Agency (EMA) consultation on the guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials' (EMA/15975/2016) [Issued July 2017]

ICH E17 Draft Guidelines on "Multi-Regional Clinical Trials". [Issued December 2016]

Department of Health Consultation: National Data Guardian for Health and Care’s Review of Data Security, Consent and Opt-Outs. [Issued September 2016]

Position of research and patient organisations: Implementing the General Data Protection Regulation [2016/679] to maintain a competitive environment for research in Europe. [Issued September 2016]

HRA’s consultation: Network response to the UK Health Policy Framework

HRA’s consultation: Network response to the UK Policy Framework for Health and Social Care Research

HRA's consultation on Transparency - Registration and Reporting (Archive)

SIOP-E Joint Statement on Low Intervention Trials related to the Clinical Trials Regulations

NIHR CLRN Clinical Themes consultation

House of Commons Science and Technology Select Committee inquiry into clinical trials and disclosure of data and (Appendix 1)

NHS EU Office consultation on new EU Clinical Trials Regulations:

MHRA Public Consultation (MLX 377): Fees legislation for 2013:

MHRA Consultation on Clinical Trials Insurance

EU DATA Protection Regulations - Position Statement.

Health Research Authority Research Sponsor Responsibilities Consultation

Network response to  the proposals for the content of the summary of the results of clinical trials (Annex IIIa) and position statement on Transparency.

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