Responsibilities of the Principal Investigator. The Principal Investigator will act as the xxxxxxx of the Data Set, including, but not limited to,
Responsibilities of the Principal Investigator. The Principal Investigator undertakes to: conduct the Clinical Trial in accordance with the Protocol and the applicable laws; adhere to any instructions regarding the conduct of the Clinical Trial, as received from the Sponsor or set forth in the Good Clinical Practice; perform the Clinical Trial, which includes Trial Participants recruitment, performing services specified in the Protocol and the Investigator’s Brochure, providing – in cooperation with the Site – proper medical care to the Participants during the Trial, completing CRFs, and reporting on Trial progress to the Sponsor; comply with the principles of collecting, reporting and storing data as set forth in this Agreement, the Protocol, and generally applicable laws, within the timeframes and according to the requirements specified by the Sponsor; ensure the protection of data, including personal data of the Trial Participants collected as part of the Trial, and to keep such data confidential; hand over, upon each request of the Sponsor, any materials and studies collected and developed as part of performance hereunder. Upon the consent of the CRO, the Principal Investigator shall appoint a trial team among the employees and contractors of the Site, as necessary to perform the Clinical Trial, exhibiting the necessary skills and qualifications (the “Trial Team”). The Principal Investigator represents that every member of the Trial Team abide by the provisions of this Agreement and the Protocol. The Principal Investigator shall be liable for the actions or omissions of the Trial Team during the conduct of the Clinical Trial as if they were the Principal Investigator’s own actions or omissions. The Principal Investigator shall exercise direct supervision over the correct performance of the activities entrusted by him/her to selected persons and shall evaluate and accept the work once delivered. The Principal Investigator represents that he/she has the necessary qualifications and licences to act as an investigator, which shall be evidenced, upon the Sponsor’s request, by presenting the relevant documents (as required by the applicable laws). If a Serious Adverse Event (SAE) occurs, the Principal Investigator is obliged to adhere to the Sponsor’s instructions, as set out in the Protocol or in other instructions handed over by the Sponsor, and to report such an event immediately to the Site and the Sponsor within 24 hours of becoming aware thereof. In the event of receiving queries from the CRO or the...
Responsibilities of the Principal Investigator. The principal investigator shall carry out all works related to the conduct of the post-autorization study and shall specifically undertake to: Co-ordinate, supervise and direct his/her collaborators. Before the end date of the study, include a number of …... patients in the study. Inform the patients as fully as possible, and obtain their written informed consent in accordance with the prevailing legal requirements applicable to post-autorization studies. Follow up the patients in compliance with the protocol and prevailing regulatory requirements for post-autorization studies. Collect and store all information and forward all documents to the sponsor, as established in the protocol. Immediately report the monitor appointed by the sponsor any serious or unexpected adverse events by the fastest possible means. Report to the sponsor the number of patients who have not attended the follow-up visits . Provide data on each visit a soon as these are produced in order to verify such data and their consistency with previous and subsequent visits. Respect the confidential nature of the clinical data pertaining to each participant and maintain their privacy.
Responsibilities of the Principal Investigator. Collaborate with authorized CALM staff in fulfilling sections 1.3, 2, and 11 of this agreement (see also agreement #OA20170123 between SBUSD and UCSB). • Coordinate and oversee all aspects of the research activities including recruitment, data collection, and prevention programming offered to participants. • Supervise all research and prevention programming staff. • Communicate with SBUSD Sponsors to coordinate activities.
