[Organization, administration, and performance of clinical studies].
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.
Bachner
Mark
M
3. Medizinische Abteilung, Zentrum fur Onkologie und Hamatologie, Kaiser Franz Josef-Spital, Wien, Osterreich. mark.bachner@wienkav.at
Steininger
Tanja
T
Gneist
Margit
M
D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D005858:Germany; D019983:Guideline Adherence / Q000458:organization & administration*; D007258:Informed Consent / Q000592:standards*; D017410:Practice Guidelines as Topic; D012106:Research / Q000458:organization & administration*; D012107:Research Design