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

 

The 4 nations contracting leads group has issued the following guidance in relation to “restart”, and it has been endorsed by the Association of the British Pharmaceutical Industry.

“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.”

For assistance with contract drafting and negotiation for clinical trials or collaboration projects in research development and innovation, please contact Andrew Fox, Research Contracts Officer at HSC Innovations.  All correspondence should be sent to ResearchContracts@innovations.hscni.net for further information and assistance.

Feedback from HSC organisations on contractual variations or concerning difficulties negotiating contractual variations with Sponsors (and CROs) should be provided to HSC Innovations at ResearchContracts@innovations.hscni.net, whereby these will be considered by the UK Contracting Leads group."