Volume 25, Issue 1 - Authors and Authorship
Authorship of clinical trial documents
Author: Raquel Billiones
Abstract
Authorship of publications has been the subject of much public debate; however, authorship of clinical trial documents such as clinical study protocols, clinical study reports, investigator’s brochures and inform ed consent forms has not really been given much attention. This article looks at the common practices of authorship attribution and signing off on these documents and examines what the ICH guidelines, on which their contents are based, say about these issues. The implications of the EMA Policy 0070 on clinical trial disclosure are discussed.
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References
- ICH E6 (R1) Guideline 1996. Guideline for Good Clinical Practice.
- ICH E6 (R2) Guideline 2015. Integrated Addendum to ICH E6 (R1): Guideline for Good Clinical Practice.
- EMA Policy 0070 02 October 2104. Policy on Publication of Clinical Data for Medicinal Products for Human Use.
- EMA 07 September 2015. Key aspects related to the submission of clinical reports for the purpose of publication in accordance with EMA Policy 0070.
- ICH E3 Guideline 1997. Structure and Content of Clinical Study Reports.
- ICH E3 Guideline 2012. Structure and Content of Clinical Study Reports Questions & Answers (R1).
- EMA-CPMP 2001. Note for Guidance on Coordinating Investigator Signature of Clinical Study Reports.
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