15. Reference list

Section 15 of a clinical study report lists the articles from the literature that are pertinent to the evaluation of the study. Copies of the important publications are attached in two appendices, and the references follow one of two internationally accepted citation standards.

What belongs in the list

Under ICH E3, a list of articles from the literature pertinent to the evaluation of the study should be provided. ¹

Where the copies go

Copies of important publications should be attached in Appendices 16.1.11 and 16.1.12. ¹ Appendix 16.1.11 holds publications based on the study, and Appendix 16.1.12 holds important publications referenced in the report. ²

A search for what Appendix 16.1.12 requires turns up little, and one practising writer found no instructions for it in ICH or FDA guidance documents. ³ The recommendation that writer generally follows is to include in the appendix any paper necessary to understanding some aspect of the disease, the assessment methods or the statistical methods used in the study, or any other characteristic of the study that would not be considered general knowledge. ³ In that writer’s experience, not all the background references used in a protocol or a statistical analysis plan that do not meet that test need to be provided. ³

How the references are formatted

References should follow the internationally accepted standards of the 1979 Vancouver Declaration on “Uniform Requirements for Manuscripts Submitted to Biomedical Journals”, or the system used in “Chemical Abstracts”. ¹