Modifications of the mCTAs. The mCTAs have been developed through many years of negotiation and discussion between a wide stakeholder group. Prior to execution of a clinical trial agreement, it is necessary for trial-specific information to be appended to, or options selected within, the mCTAs. The information required/options are identified on the front page of the mCTAs (and throughout the mCTAs in yellow highlight). Other than the need to add/select information as specified, it is strongly recommended by all the UK Health Departments that the mCTAs should be used without modification. Any request by a sponsor/CRO to modify the mCTAs and/or to use any agreement to contract with a site other than the appropriate mCTA, should be disclosed in the IRAS submission (a version of the template proposed for use, with tracked changes and details justification should be provided). In England and Wales, NHS organisations are required to use only an unmodified mCTA or CRO-mCTA (as appropriate and applicable). In exceptional circumstances this requirement may be waived by the letter of HRA and HCRW Approval for the study. Such waivers require UK agreement from the UK Four Nations Contracting Leads Group. Similarly, proposals for modifications to mCTAs for use with sites in Scotland or Northern Ireland will also be escalated to the UK Group. Sponsors should be aware that proposing modifications to template agreements is likely to result in significant delay and does not oblige NHS organisations to agree the modified agreement, even where a waiver is centrally agreed for its use. Unmodified use is strongly recommended.
Modifications of the mCTAs. The mCTAs have been developed through negotiation and discussion between a wide stakeholder group. Prior to execution of a clinical trial agreement, it is necessary for trial-specific information to be appended to, or options selected within, the mCTAs. The information required/options are identified on the front page of the mCTAs (and throughout the mCTAs in yellow highlight). Other than the need to add/select information as specified, it is strongly recommended by all the UK Health Departments that the mCTAs should be used without modification. In England and Wales, NHS organisations are required to use only an unmodified mCTA or CRO-mCTA (as appropriate and applicable). In exceptional circumstances this requirement may be waived by the letter of HRA and HCRW Approval for the study, but Sponsors should be aware that this process may cause significant delay and does not oblige NHS organisations to agree the modified agreement. Unmodified use is strongly recommended.
Modifications of the mCTAs. The mCTAs have been developed through negotiation and discussion between a wide stakeholder group. Prior to execution of a clinical trial agreement, it is necessary for trial specific information to be appended to the mCTAs. The information required is identified on the front page of the mCTAs. Notwithstanding the inclusion of this information, it is strongly recommended by all the UK Health Departments that the mCTAs should be used without modification.
