Setting up a randomized clinical trial in the UK: Approvals and process

Journal of Orthodontics

Volumn 40, Issue 2, 2013, Pages 104-111

  Greene, Louise Eleanor ^a   Bearn, David R ^a  

^a DUNDEE DENTAL HOSPITAL AND SCHOOL   (United Kingdom)

Author keywords

Clinical trials; Ethics

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); CONFIDENTIALITY; DEVICE APPROVAL; DRUG APPROVAL; ETHICS; FACTUAL DATABASE; HUMAN; HUMAN EXPERIMENT; LEGAL ASPECT; METHODOLOGY; NATIONAL HEALTH SERVICE; ONLINE SYSTEM; ORGANIZATION AND MANAGEMENT; PEER REVIEW; PRACTICE GUIDELINE; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL (TOPIC); REGISTER; RESEARCH ETHICS; STANDARD; UNITED KINGDOM;

CLINICAL TRIALS; ETHICS;

CLINICAL PROTOCOLS; CONFIDENTIALITY; DATABASES, FACTUAL; DEVICE APPROVAL; DRUG APPROVAL; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; GREAT BRITAIN; GUIDELINES AS TOPIC; HUMAN EXPERIMENTATION; HUMANS; ONLINE SYSTEMS; PEER REVIEW, RESEARCH; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REGISTRIES; RESEARCH DESIGN; SECURITY MEASURES; STATE MEDICINE;

EID: 84880344630     PISSN: 14653125     EISSN: None     Source Type: Journal    
DOI: 10.1179/1465313312Y.0000000031     Document Type: Article

References (18)

1. Fairley JW. Philosophical, scientific and statistical background to evidenced based medicine. 2009, available at: http://www.entkent.com/ebm- philosbkd.html (accessed 5 June 2012).
2. Integrated Research Application System. Available at: http://myresearchproject.org.uk (accessed 5 June 2012).
3. The Medicines for Human Use (Clinical trials) Regulations 2004 No. 1031. Available at: http://www.legislation.gov.uk/uksi/2004/1031/contents/made (accessed 5 June 2012).
4. Department of Health Research Government Framework for Health and Social Care. Second Edition. 2005, Available at: http://www.dh.gov.uk/en/ Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH-4108962 (accessed 5 June 2012).
5. Scottish Executive Health department Research Governance Framework for Health and Community Care. Second Edition. 2006, Available at: http://www.cso.scot. nhs.uk/publications/ResGov/Framework/RGFEdTwo.pdf (accessed 5 June 2012).
6. Tayside Medical Science Centre (TASC). Available at: http://tahsc.org (accessed 5 June 2012).
7. Department of Health. The Caldicott Committee report on the review of patient-identifiable information. December 1997, available at: http://www.dh.gov.uk/en/Publicationsand statistics/Publications/ PublicationsPolicyAndGuidance/DH-4068403 (accessed 5 June 2012).
8. The Scottish Government. Available at: http://www.scot land.gov.uk (accessed 5 June 2012).
9. National Research Ethics Service. Available at: http://www.nres.nhs.uk (accessed 5 June 2012).
10. EC Medical Devices Directives 1. Guidance for manufacturers on clinical investigations to be carried out in the UK, updated February 2012. Available at: http://www.mhra.gov. uk/home/groups/esera/documents/publication/con007504.pdf (accessed 5 June 2012).
11. Medicines and Healthcare Products Regulatory Agency. Available at: http://www.mhra.gov.uk (accessed 5 June 2012).
12. Community Clinical Trial System. Available at: http://www.eudract.ema. europa.eu (accessed 5 June 2012).
13. Council Directive 93/42/EEC of 14th June 1993. Available at: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri5 CELEX:31993L0042:EN:HTML (accessed 5 June 2012).
14. National Institute for Health Research Clinical Research Network. Available at: http://www.crncc.nihr.ac.uk (accessed 5 June 2012).
15. Northern Ireland Clinical Research Network. Available at: http://www.nicrn.hscni.net (accessed 21 August 2012).
16. Chief Scientist Office. Available at: http://www.cso.scot.nhs.uk (accessed 21 August 2012).
17. National Institute for Social Care and Health Research Clinical Research Centre. Available at: http://www.nischr-crc. wales.nhs.uk (accessed 21 August 2012).
18. Clinicaltrials.gov. Available at: http://www.clinicaltrials.gov (accessed 5 June 2012).