Statement on commercial and non-commercial site agreement (contract) variation at restart

Date: 30 September 2020

Where an unmodified UK template agreement (see here and here) has been used for the contracting of a research site, mutual agreement to a modified recruitment target and/or to the timelines for study delivery does not require a formal contract variation. The UK template agreements have been drafted to allow, under certain circumstances, for variance from these targets without breach of contract occurring. Agreement to the revised targets (where applicable) should be reached and documented (e.g. by exchange of email) as part of the practicalities involved in restarting the research activity.

Where a modified or non-standard agreement has been used, parties to the agreement should consider whether the above applies.

Where activities occurring under a site agreement (contract) will change such that the finance schedule requires modification, this should be handled in accordance with the contract modification arrangements specified in the agreement. Restarting activities requiring changes to the financial schedule should not be delayed until contract variation is completed. Instead, activities should restart in a timely manner whilst good faith negotiation between the parties continues to finalise and agree the variation.

This statement is endorsed by the national coordinating functions of the four UK nations and the Association of the British Pharmaceutical Industry.”

Feedback

If you wish to provide feedback on the current templates, that you would like considered for future versions, or have any questions relating to the template agreements, please contact:

alastair.nicholson@hra.nhs.uk for England

david.brownlee@innovations.hscni.net for Northern Ireland

douglas.young@nhslothian.scot.nhs.uk for Scotland

fiona.dunn3@wales.nhs.uk for Wales

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