Table 1 Guidelines included in this review (primary source)

Institutional or named guidelines

A method for Rapid, Objective and Structured Evaluation (ROSE) of protocol of a randomised clinical trial (2005).

A Standard for the Scientific and Ethical Review of Trials (ASSERT) statement (2007).

Canadian Institutes of Health Research (2010 September) Funding opportunity details.

Centers for Disease Control and Prevention (2006) Developing a protocol: a guide for CDC investigators.

Chaput de Saintonge (1977) - produced by past and present members of Clinical Trials Unit, Department of Pharmacology and Therapeutics, London Hospital Medical College.

Clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases (2009).

Code of Federal Regulations (2002): U.S. Food and Drugs. 21CFR312.23.

Code of practice for the clinical assessment of licensed medicinal products in general practice. (1983)

Guidelines for the preparation of E.R.T.C. cancer clinical trial protocols (1980).

International Conference on Harmonisation (1998). Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (ICH E6).

International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002). Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)

Merck investigator studies program protocol template (2008). Requirements for submitting a full proposal.

National Health Service Department of Health [UK] (2011). Clinical trials toolkit - Based on ‘Detailed guidelines on the principles of good clinical practice in the conduct in the European Union of clinical trials on medicinal products for human use Ver 5.1’

Pfizer Investigator-Initiated Research Program (2010). Investigator-initiated research & requests for pure substance (CTP).

Programm klinische studien leitfaden für die antragstellung (2010). Deutsche Forschungsgemeinschaft.

Schneidermann (1961) - Prepared for Cancer Chemotherapy National Service Center of the National Cancer Institute

The Trial Protocol Tool: The PRACTIHC software tool that supports the writing of protocols for pragmatic randomized controlled trials. (2006)

U.S. Department of Health and Human Services (2006). Public Health Service Grant Application (PHS 398).

Warren (1978) - produced by the South-east Thames Regional Health Authority's regional research committee (for which author was chairman)

Wellcome Trust (2011). Funding for clinical trials. Requirements for applicants.

Working group of the Commission on Dental Materials, Instruments, Equipment and Therapeutics (1977). Recommended outline for a research protocol.

Book chapters

Other