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Timeline of Commercial Contract Research Set-up Improvements

 

Contents

2003

Department of Health and ABPI Model Clinical Trial Agreement first launched.

2008

NIHR Industry Costing Template first launched for use following specific recommendation for a transparent and consistent national costing system in the 2006 Cooksey Report.

2016

HRA approval implemented to set up studies by integrating the assessment of legal compliance and the independent ethics review in one process: one application and one collated approval.

2017

NHS England consultation proposes approach to streamline costing and contracting for all commercial contract studies using existing tools: the costing template and model agreement.

2018

1 October: Stakeholder engagement facilitated by the NIHR Clinical Research Network to inform details of a single cost review process for NHS providers including updates to the Industry Costing Template methodology, reiterated use of an unmodified model agreement and embedding national review standards.

Quarter 4: Technical development of online Industry Costing Template within NIHR Central Portfolio Management System commences with decommissioning of the excel version to effectively facilitate a single review process.

2019

Quarter 1: Establish community of reviewers to deliver and inform single review business processes and costing methodology refinement.

Quarter 2: Online Industry Costing Template functionality available to support collaborative review approach with a standardised Financial Appendix content output and improved governance of cost values.

Quarter 3 - Continual testing and refinement: Online functionality, outputs and single review process overseen by Industry Costing Governance Group.

Quarter 4 - Monitoring impact: First year review of business process analytics and feedback to inform future developments.

2020

Integrated digital systems: work towards template integration with IRAS e.g. linkages with submission information and online model agreement.