A technical introduction to the basic requirements of clinical trials

EJHP Practice

Volumn 15, Issue 5, 2009, Pages 20-22

  Kuchinke, Wolfgang ^a   Ohmann, Christian ^a  

^a Department of Orthopedic Surgery   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; ETHICS; HEALTH INSURANCE; HUMAN; HUMAN RIGHTS; INFORMATION PROCESSING; INFORMED CONSENT; NONHUMAN; PATIENT RIGHT; PATIENT SAFETY; PATIENT SELECTION; PHARMACIST; PROFESSIONAL PRACTICE; WELLBEING;

EID: 70450187407     PISSN: 17819989     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (15)

1. ICH-GCP E6 (R1) Guideline for Good Clinical Practice. [cited 2009 October 18] Available from: www.emea.europa.eu/pdfs/human/ich/013595en.pdf.
2. Directive 2001/20/EC of the European parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Commun. 2001;L121:34-44.
3. Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. Official J Eur Commun. 2005;L91:9-19.
4. VOLUME 4, Good manufacturing practices, ANNEX 13, Manufacture of investigational medicinal products. Brussels July 2003. [cited 2009 October 18] Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-4/ pdfs-en/an13final-24-02-05.pdf
5. https://eudract.emea.europa.eu/eudract/index.do [cited 2009 October 18].
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7. Ohmann C, Kuchinke W. Meeting the Challenges of Patient Recruitment. Int J Pharm Med. 2007;21(4):263-270
8. Moher D, Schulz KF, Altman DG. The CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials. Ann Intern Med. 2001;134(8):657-662 (Pubitemid 32322244)
9. www.clinicaltrials.gov [cited 2009 October 18].
10. www.cdisc.org/models/odm/v1.3/index.html [cited 2009 October 18].
11. Ruiz-Canela M, de Irala-Estevez J, Martínez-González MA, et al. Methodological quality and reporting of ethical requirements in clinical trials. J Med Ethics. 2001;27(3):172-176
12. Salzberg M, Müller E. Quality requirements in clinical studies: a necessary burden? Swiss Med Wkly. 2003;133(31-32):429-432
13. Demotes-Mainard J, Ohmann C. European Clinical Research Infrastructures Network: promoting harmonisation and quality in European clinical research. Lancet. 2005; 365(9454):107-108
14. C Ohmann and the Transnational Working Group on Data Management. Deliverable D10: GCP-compliant data management in multinational trials, ECRIN Paris, 3rd version, 17 June 2008. [cited 2009 October 18] Available from: www.ecrin.org.
15. www.ecrin.org [cited 2009 October 18].