Guide to writing a Clinical Trials Protocol - University Hospital ...

Research Governance A statement that the study will be conducted in compliance with the Research Governance Frameworkfor Health and Social Care, the Medicine for Human Use (Clinical Trials) Regulation 2004 and ICH GCP*.Finance Provide any details of the financial arrangements for the study if not assessed in a different document. Provide details of any payments to be made to participants.Indemnity Describe arrangements for providing cover for non-negligent and negligent harm*Reporting and dissemination Detail of plans for publicising the results of the study including that the trial will be reported in accordancewith the CONSORT (Consolidated Standards of Reporting Trials) statement the results(http://www.consort-statement.org/)Tables, figures and referencesAppendicesFor example: Patient information sheet. Patient consent form. GP letter. Data collection forms. Summary of product characteristics. Investigators brochure.Adapted with kind permission from UBHT R&D Information Sheet No.1a, v1.0 10-11-04\\sghthq12\CGOVDEV\CGOVDEV\RESEARCH\Information Sheets\SUHT Information sheets\New Logo\IS3a Guide to writing a protocol for a CTIMPv1.3 01-02-07.docPage 6 of 6