Common definition for categories of clinical research: A prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

Trials

Volumn 10, Issue , 2009, Pages 95-

  Kubiak, Christine ^a   De Andres Trelles, Fernando ^m   Kuchinke, Wolfgang ^b   Huemer, Karl Heinz ^c   Thirstrup, Steffen ^d   Whitfield, Kate ^d   Libersa, Christian ^a   Barraud, Béatrice ^a   Grählert, Xina ^p   Dreier, Gabriele ^l   Grychtol, Ruth ^l   Temesvari, Zsuzsa ^e   Blasko, Gyorgy ^e   Kardos, Gabriella ^e   O'Brien, Timothy ^g   Cooney, Margaret ^f   Gaynor, Siobhan ^f   Schieppati, Arrigo ^h   Sanz, Nuria ⁱ   Hernandez, Raquel ⁱ   Asker Hagelberg, Charlotte ^k   Johansson, Hanna ^k   Bourne, Sue ^o   Byrne, Jane ^q   Asghar, Adeeba ^j   Husson, Jean Marc ⁿ   Gluud, Christian ^d   Demotes Mainard, Jacques ^a   more..

^a INSERM   (France)

^b HEINRICH HEINE UNIVERSITY   (Germany)

^c MEDICAL UNIVERSITY OF VIENNA   (Austria)

^d Rigshospitalet   (Denmark)

^e Medical Research Council   (Hungary)

^f Molecular Medicine Ireland   (Ireland)

^g NATIONAL UNIVERSITY OF IRELAND   (Ireland)

^h MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

ⁱ HOSPITAL CLÍNIC   (Spain)

^j UK Clinical Research Network   (United Kingdom)

^k Karolinska Trial Alliance   (Sweden)

^l UNIVERSITY OF FREIBURG   (Germany)

^m UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

ⁿ European Forum for Good Clinical Practice   (Belgium)

^o UK Clinical Research Collaboration   (United Kingdom)

^p DRESDEN UNIVERSITY OF TECHNOLOGY   (Germany)

^q WYTHENSHAWE HOSPITAL   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN; VACCINE;

ALTERNATIVE MEDICINE; ARTICLE; BLOOD SAMPLING; CELL THERAPY; CLASSIFICATION; CLINICAL RESEARCH; CLINICAL STUDY; DEVICE; DIAGNOSTIC PROCEDURE; EPIDEMIOLOGICAL DATA; EUROPE; EUROPEAN UNION; GENERAL SURGERY; HEALTH SURVEY; NUTRITION; PERCEPTION; PROFESSIONAL STANDARD; TISSUE ENGINEERING; TRANSFUSION; TRANSPLANTATION; VALIDATION PROCESS;

EID: 70449699915     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-10-95     Document Type: Article

References (10)

1. Directive 95/46/EC of the European Parliament and of the Council of 24 October on the protection of individuals with regard to the processing of personal data and on the free movement of such data. Official Journal L 1995, 281:31-50.
2. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 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 Journal L 2001, 121:34-44.
3. Commission Directive 2003/94/EC of the 8 October laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Official Journal L 2003, 262:22-26.
4. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004, on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cell. Official Journal L 2006, 294:32-50.
5. Commission 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 Journal L 2005, 91:13-19.
6. Hartmann M, Hartmann-Vareilles F. The clinical trials Directive: how is it affecting Europe's non-commercial research?. PLOS Clinical Trials June 2006, e13.
7. ECRIN. , http://www.ecrin.org
8. Health Research Classification System. , http://www.hrcsonline.net/hrcs/files/HRCS_Document.pdf
9. European medical research councils (EMRC) - Forward Look Investigator-Driven Clinical trials. , http://www.esf.org/nc/research-areas/medical-sciences.html
10. Janssen H, Budashewitz P. Categories and Design of Investigator-Driven Clinical Trials. EMRC Consensus Conference Strasbourg 2008,