This HRA consultation has closed and is displayed for reference only.
In October 2015 we sought comment from NHS organisations in England on a revised model Clinical Trial Agreement (mCTA).
The original mCTA was released in 2003 and revised in 2006 and 2011. It was intended to be used to agree the relationship between, and the responsibilities of, commercial sponsors and their research sites in relation to commercial contract clinical trials. The body of the agreement was written for use without modification, whereas the schedules could be tailored to reflect study specifics. Use of the template thereby ensured compliance with applicable law and institutional arrangements whilst minimising the review required at site.
Although the mCTA has achieved wide acceptance from NHS sites and commercial sponsors, a number of commercial sponsors make modifications to the body of the agreement, requiring sites to undertake additional review. Against this background, and aware that many of these modifications reflect companies responding to changes in the research landscape since 2011, the ABPI have led a review of the 2011 version.
The review commenced in early 2015, with a volunteer group of ABPI members and representatives from the HRA and NIHR CRN commenting upon a redraft focused on the following areas:
- Bribery Act
- Clinical trial transparency
- Healthcare professional payment transparency
- Data protection and informed consent from study patients
- Access to debarment information about investigators and consent to hold data on investigators.
- Data retention post trial
- Adverse events reporting
- New ABPI guidance on clinical trial compensation guidelines
The working group met a number of times through summer 2015, with the intention of agreeing the suggested redraft and to address other reasons for common modifications. Group members were encouraged to seek input from within their organisations and contributions were also sought from a wider audience, as the ABPI and HRA updated key stakeholders on progress.
Significant additions have been made to the appendices to support the functionality of the document:
- The protocol is included within the agreement by reference within the definitions, instead of by being appended as appendix 1
- The new appendix 1 (the former appendix 2; timelines) has been updated to record the division of responsibilities and activities between the parties, bringing it in line with the model non-commercial agreement (mNCA).
- Appendix 2 is the updated version of the ABPI compensation guidelines.
- Appendix 4, which is intended to be optional, replaces the old appendix 5 with the finance schedule developed by the National Institute for Health Research Clinical Research Network (NIHR CRN) Industry Costing Group.
- Appendix 5 is the existing conditions applicable to the investigator, with two additional clauses relating respectively to indemnity and bribery/corruption.
- Appendix 6 provides for material transfer clauses, bringing the agreement in line with the UK-wide study wide governance criteria.
Comment is invited from NHS organisations in England, particularly from those responsible for signing agreements for NHS research sites. The devolved administrations for Northern Ireland, Scotland and Wales are undertaking their own review of the document, with a view to revision of their equivalent templates. The version provided is the outcome of the work undertaken by ABPI; there has been no legal review by any other bodies at this stage. The HRA is seeking views from NHS organisations in England, noting that they may wish to seek their own legal advice prior to responding.
Any companies with queries or comments should contact the ABPI.
The consultation period ran from 16 October to 13 November 2015.
- Revised model Clinical Trial Agreement [Word]
- Revised model Clinical Trial Agreement [PDF version with track changes for information]
Feedback received was analysed before a final re-drafting of the template for release. Following this, agreed changes were transposed into the primary care and CRO versions of the mCTA for England and released shortly afterwards.