![]() The ABPI has established mechanisms for obtaining feedback from Industry. The UK Four Nations Contracting Leads Group meets regularly to review user feedback and consider future revisions. Guidance Notes: mCTA and CRO-mCTA Dec 2023.The guidance notes include contact points from where advice and assistance may be obtained. ![]() Proposing modifications to the templates is likely to result in significant delay. Any proposed modifications will not be accepted unless first agreed by the UK Contracting Leads. However, the October 2023 version will continue to be accepted until June 2024. Applicants are advised to use the templates without modification. All parties should pay close attention to updates to the guidance and templates introduced from October 2023 which included the new unmodifiable financial appendix and finance schedule to align with the launch of stage 2 of the National Contract Value Review (NCVR) process.Īll new IRAS submissions should use the December 2023 version of the appropriate agreement. NHS/HSC organisations are advised to familiarise themselves and their organisational signatories with the revised mCTAs and ensure that they can implement them immediately. Research Sponsors (and CROs) should familiarise themselves with the guidance before making first use of the December 2023 versions. ![]() The accompanying Guidance Notes provide further background, an overview of the changes from the October 2023 versions and more information on how and under which circumstances the templates should be used. These template model agreements are applicable to the health services in England, Northern Ireland, Scotland and Wales they replace the October 2023 versions. The December 2023 model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) templates should be used without modification for industry-sponsored clinical trials of investigational medicinal products with NHS/HSC participants in hospitals throughout the UK Health Services. This is available on the HRA website.Ĭommercial Model Clinical Trial Agreements (mCTA and CRO-mCTA) Note: The Health Research Authority (HRA) on behalf of the UK has published General Data Protection Regulation (GDPR) transparency wording for inclusion in participant information sheets.
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