Good clinical practice investigator

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... 

Investigator s Brochure Conformity with the International Conference on Harmonization Good Clinical Practice Guideline for the... 

Clinical Trials, 1994. The rules of good clinical practice (GCP) have been partly incorporated in the Directives. A prominent feature is that it is the investigator rather than the sponsoring company who will be responsible for most aspects of the trial. Following are the main features of the rulings ... 

Investigator meetings can be held only for participants of clinical trials which are conducted consistent with Good Clinical Practice and which were either approved by or notified to StJKL. 

The report of a bioequivalence study should give the complete documentation of its protocol, conduct and evaluation complying with good clinical practice rules (4). The relevant ICH guideline (13) can be used in the preparation of the study report. The responsible investigator(s) should sign their respective sections of the report. Names and affiliations of the responsible investigator(s), site of the study and period of its execution should be stated. 

EMEA. ICH Topric E6, 1996, Guideline for Good Clinical Practice Section 7.3 Content of the Investigator s Brochure. London EMEA, 1996. 

---