PMID- 18487861
OWN - NLM
STAT- MEDLINE
DCOM- 20080710
LR  - 20121115
IS  - 1423-0240 (Electronic)
IS  - 0378-584X (Linking)
VI  - 31 Suppl 2
DP  - 2008
TI  - [Organization, administration, and performance of clinical studies].
PG  - 3-6
LID - 10.1159/000113030 [doi]
AB  - This contribution deals with all important organizational and administrative 
      aspects of clinical studies in German speaking countries. All trials are to be 
      executed in accordance with the Good Clinical Practice (GCP) Guidelines. GCP 
      applies to the process of designing, conducting, recording, and reporting of 
      clinical studies. Compliance with GCP facilitates the mutual acceptance of 
      resulting clinical data by the respective regulatory authorities worldwide. 
      Before initiating a clinical study the investigator has to obtain written and 
      dated approval from the responsible ethics committee, the competent authorities, 
      and the hospital administration. The investigator's study file contains all 
      essential study documents. One of the most important tasks of an investigator is 
      to properly inform the prospective subjects and to obtain their informed consent. 
      All relevant treatment-related information has to be recorded in the patient 
      files. These source data are transferred to case report forms. During monitoring 
      visits, audits, and inspections, source data verification will be performed 
      routinely. Any adverse events (AEs) must be documented according to the CTCAE, 
      the Common Terminology Criteria for Adverse Events. All serious adverse events 
      (SAEs) have to be reported to the sponsor immediately. At the end of the study a 
      termination visit is performed, and all authorities are officially informed about 
      the termination of the trial.
CI  - Copyright 2008 S. Karger AG, Basel.
FAU - Bachner, Mark
AU  - Bachner M
AD  - 3. Medizinische Abteilung, Zentrum fur Onkologie und Hamatologie, Kaiser Franz 
      Josef-Spital, Wien, Osterreich. mark.bachner@wienkav.at
FAU - Steininger, Tanja
AU  - Steininger T
FAU - Gneist, Margit
AU  - Gneist M
LA  - ger
PT  - English Abstract
PT  - Journal Article
TT  - Organisation, Administration und Durchfuhrung von klinischen Studien.
DEP - 20080418
PL  - Switzerland
TA  - Onkologie
JT  - Onkologie
JID - 7808556
SB  - IM
MH  - Clinical Trials as Topic/*methods/*standards
MH  - Germany
MH  - Guideline Adherence/*organization & administration
MH  - Informed Consent/*standards
MH  - *Practice Guidelines as Topic
MH  - Research/*organization & administration
MH  - Research Design
EDAT- 2008/06/14 09:00
MHDA- 2008/07/11 09:00
CRDT- 2008/06/14 09:00
PHST- 2008/06/14 09:00 [pubmed]
PHST- 2008/07/11 09:00 [medline]
PHST- 2008/06/14 09:00 [entrez]
AID - 000113030 [pii]
AID - 10.1159/000113030 [doi]
PST - ppublish
SO  - Onkologie. 2008;31 Suppl 2:3-6. doi: 10.1159/000113030. Epub 2008 Apr 18.