ABPI clinical trial disclosure toolkit

This toolkit provides good practice guidelines, disclosure checklists and a template standard operating procedure for pharmaceutical companies. These materials will be updated regularly in line with changes to international regulatory requirements.

The toolkit consists of the following 11 documents: Folder 1 - Points to consider when managing disclosure. - Form R100 – this template form provides a framework for assigning named individuals to the SOP tasks. - Template standard operating procedure (SOP) on clinical trial registry, results posting and publications. - Process flow maps to map companies disclosure processes relating to trial registration and results disclosure. Folder 2 - Process checklist: Trial registration – this checklist (PDF and Excel version available) outlines the key process steps to be assessed against a disclosure SOP. - Process checklist: Results disclosure – this checklist (PDF and Excel version available) outlines the key process steps to be assessed against a disclosure SOP. Folder 3 - Task checklist: Trial registration – this checklist (PDF and Excel version available) outlines the key tasks to be assessed against a disclosure SOP. - Task checklist: Results disclosure – this checklist (PDF and Excel version available) outlines the key tasks to be assessed against a disclosure SOP. Folder 4 - Self-training and Q&A materials: Template SOP – this presentation contains training materials and frequently asked questions on the template SOP document. - Self-training and Q&A materials: Checklists – this presentation contains training materials and frequently asked questions to support use of the four checklists. -

Useful links to key regulatory and government publications relating to transparency and disclosure commitments. - Review of materials The information in this toolkit is provided in good faith, and every reasonable effort is made to ensure that it is accurate. The toolkit is not intended and should not be construed as regulatory or legal advice. The ABPI cannot in any circumstances accept responsibility for any errors or omissions and users should satisfy themselves as to their legal obligations.