Good Clinical Practice. This study will be conducted in accordance with the International Conference on Harmonization (ICH) for Good Clinical Practice (GCP) and the appropriate regulatory requirements. The Investigator will be thoroughly familiar with the appropriate use of the study medication as described in the protocol and the Investigator’s Brochure. Essential clinical documents will be maintained to demonstrate the validity of the study and the integrity of the data collected. The Investigator/institution should establish master files at the beginning of the study which will be maintained and updated during the study and retained thereafter according to the appropriate regulations.
Appears in 4 contracts
Samples: Trial Services Agreement (Radius Health, Inc.), Trial Services Agreement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.)
Good Clinical Practice. This study will be conducted in accordance with the International Conference on Harmonization (ICH) for Good Clinical Practice (GCP) (27) and the appropriate regulatory requirements. The Investigator will be thoroughly familiar with the appropriate use of the study medication as described in the protocol and the Investigator’s Brochure. Essential clinical documents will be maintained to demonstrate the validity of the study and the integrity of the data collected. The Investigator/institution should establish master files at the beginning of the study which will be maintained and updated during the study and retained thereafter according to the appropriate regulations.
Appears in 3 contracts
Samples: Work Statement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.)
