CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. 3.1. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions.
Appears in 5 contracts
Samples: Trial Agreement, Template Clinical Trial Agreement, Trial Agreement
CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. 3.1. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation Authorization for the conduct of the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require the Institution and Principal Investigator to apply for the Clinical Trial Authorisation for SponsorAuthorisation, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of the Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions.
Appears in 1 contract
Samples: www.nfu.nl
CLINICAL TRIAL GOVERNANCE AND COMPLIANCE. 3.1. The Sponsor shall be responsible for obtaining and maintaining Clinical Trial Authorisation for the Clinical Trial and substantial amendments to the Protocol. The Sponsor may require require, by written notice the Principal Investigator to apply for the Clinical Trial Authorisation for Sponsor, in which case the Principal Investigator shall keep the Sponsor fully apprised of the progress of Ethics Committee submissions and shall upon request provide the Sponsor with all correspondence relating to such submissions.
Appears in 1 contract
Samples: Trial Agreement