Guide to writing a Clinical Trials Protocol - University Hospital ...
Guide to writing a Clinical Trials Protocol - University Hospital ...
Guide to writing a Clinical Trials Protocol - University Hospital ...
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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 (<strong>Clinical</strong> <strong>Trials</strong>) 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 <strong>to</strong> be made <strong>to</strong> 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 <strong>Trials</strong>) 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. Investiga<strong>to</strong>rs 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 <strong>Guide</strong> <strong>to</strong> <strong>writing</strong> a pro<strong>to</strong>col for a CTIMPv1.3 01-02-07.docPage 6 of 6
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