1. National Institute of Neurological Disorders and Stroke. NINDS glossary of clinical research terms. www.ninds.nih.gov/research/clinical_research/basics/glossary.htm (accessed 2015 Aug 15).
2. Johns Hopkins Medicine. Coordinating center functions and multi-site studies. www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/coordinating.html (accessed 2015 Aug 9).
3. Code of Federal Regulations Title 21. Labeling of an investigational new drug. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.6 (accessed 2015 Aug 9).
4. European Commission. Clinical trials directive 2001/20/EC. www.ec.europa.eu/health/human-use/clinical-trials/directive/index_en.htm (accessed 2015 Sep 16).
5. Commission directive 2003/94/EC. Good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use;Commission of the European Communities;Office Journal of the European Union,2013