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Table 1 Guidelines included in this review (primary source)

From: Guidelines for randomized clinical trial protocol content: a systematic review

Guideline Reference
Institutional or named guidelines  
A method for Rapid, Objective and Structured Evaluation (ROSE) of protocol of a randomised clinical trial (2005). [56]
A Standard for the Scientific and Ethical Review of Trials (ASSERT) statement (2007). [71]
Canadian Institutes of Health Research (2010 September) Funding opportunity details. [75]
Centers for Disease Control and Prevention (2006) Developing a protocol: a guide for CDC investigators. [69]
Chaput de Saintonge (1977) - produced by past and present members of Clinical Trials Unit, Department of Pharmacology and Therapeutics, London Hospital Medical College. [55]
Clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases (2009). [59]
Code of Federal Regulations (2002): U.S. Food and Drugs. 21CFR312.23. [82]
Code of practice for the clinical assessment of licensed medicinal products in general practice. (1983) [63]
Guidelines for the preparation of E.R.T.C. cancer clinical trial protocols (1980). [53]
International Conference on Harmonisation (1998). Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (ICH E6). [70]
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) [42]
Merck investigator studies program protocol template (2008). Requirements for submitting a full proposal. [74]
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’ [43, 44]
Pfizer Investigator-Initiated Research Program (2010). Investigator-initiated research & requests for pure substance (CTP). [75]
Programm klinische studien leitfaden für die antragstellung (2010). Deutsche Forschungsgemeinschaft. [81]
Schneidermann (1961) - Prepared for Cancer Chemotherapy National Service Center of the National Cancer Institute [66]
The Trial Protocol Tool: The PRACTIHC software tool that supports the writing of protocols for pragmatic randomized controlled trials. (2006) [46]
U.S. Department of Health and Human Services (2006). Public Health Service Grant Application (PHS 398). [73]
Warren (1978) - produced by the South-east Thames Regional Health Authority's regional research committee (for which author was chairman) [54]
Wellcome Trust (2011). Funding for clinical trials. Requirements for applicants. [80]
Working group of the Commission on Dental Materials, Instruments, Equipment and Therapeutics (1977). Recommended outline for a research protocol. [40]
Book chapters [38, 48, 57, 58, 7780]
Other [4952, 6062, 64, 65, 67, 68, 79]