The Principal Investigator. 5.1. Xxxxxxxxx Xxxxxxx Ami Sidi, MD of the Medical Center (hereinafter: “the Principal Investigator”) has agreed to serve as the principal investigator of the Trial
5.2. The Principal Investigator undertakes to perform the Trial in compliance with the following: (a) the Trial Protocol, (b) the Guidelines, (c) the instructions and the terms specified in the approval of the Medical Center Helsinki Committee, (d) the ICH-GCP, (e) the Helsinki Declaration, (f) the applicable laws, rules and regulations regulating such studies which are applicable in Israel, (g) written instructions and prescriptions issued by BioCancell regarding the Trial and/or the Product; all as may be amended from time to time, and (h). the requirements in accordance with the FDA Form 1572 “Statement of Investigator.” Every PI at each site must sign this form for submission to the FDA
5.3. The Principal Investigator has declared that he holds the professional ability and credentials required for performing the Trial in accordance with the Trial Protocol and any applicable laws, rules, regulations and guidelines, all as detailed above.
5.4. In the event that the Principal Investigator, for any reason whatsoever, shall be unable to conduct the Trial, or shall cease to be available for the performance of the undertakings set forth in this Agreement, the Medical Center shall use its best efforts to appoint, within 20 days, a successor investigator whose identity shall be approved in advance by BioCancell (the “Successor Investigator”). Such Successor Investigator shall undertake all the duties and responsibilities of the Principal Investigator as detailed in the Agreement. Should the Medical Center not be able to appoint a Successor Investigator, or if the appointed Successor Investigator is not acceptable by BioCancell, either party shall be entitled to terminate this Agreement forthwith and without further liability.
5.5. In the event of the replacement of the Principal Investigator, as described under this Section 5, the Principal Investigator shall have no claim towards BioCancell and/or the Medical Center and/or any third party acting on their behalf in direct or indirect connection with such replacement. Template - agreement with medical centers
The Principal Investigator for the Contract or Grant shall be responsible for executing the project in conformance with the approved budget.
The Principal Investigator. Mr/Ms/Mrs................
The Principal Investigator and the Institution must use the wording below when acknowledging a grant from XXXXX. When appropriate, such as in a scientific journal article, the grant number must be included.
The Principal Investigator. Xx. Xxxxx Xxxx;
The Principal Investigator. Xxxxxx Xxx Xxxx – will coordinate the entire project and will have full responsibility of the project development.
The Principal Investigator the SPONSOR and the monitors and auditors will observe the internal procedural rules of the HOSPITAL and the FOUNDATION, which will be provided by the latter, and also the indications on the performance of the CLINICAL TRIAL given by the CEIm responsible for monitoring them.
The Principal Investigator. For sake of clarity, the Principal Investigator is an employee of Institution and will be named in Exhibit A. The Principal Investigator represents and certifies that he or she has read and understands the Investigator’s Brochure. The Principal Investigator is not a party but must sign off read and acknowledged to the entire agreement. Prior to the commencement of the Study, the Principal Investigator shall deliver to AstraZeneca true, complete and correct copies of the Principal Investigator’s investigator statement on U.S. Food and Drug Administration (“FDA”) Form 1572 and curriculum vitae, each of which shall be signed by the Principal Investigator. During the Study, the Institution shall immediately notify AstraZeneca in writing at such time as it becomes aware that the Principal Investigator plans to leave the Institution or shall be unable to complete the Study. If the Institution and AstraZeneca are unable to agree on an acceptable substitute investigator within fifteen (15) business days following such notice, AstraZeneca may terminate this Agreement pursuant to Section 24.
The Principal Investigator. 1. The “principal investigator” as defined in Annex II is (Name, date and place of birth of the principal investigator) [‘nationality, passport No xxxx, Id number…].
2. The beneficiary shall enter into a supplementary agreement2 with the "principal investigator". The provisions of the supplementary agreement, which are not in accordance with this grant agreement, shall be deemed to be void for the purposes of this grant agreement.
1 Commission Decision of 8/X/2008 - C(2008) 5694 final. Together with the signed grant agreement the beneficiary shall transmit to the Agency a signed copy of this supplementary agreement.
The Principal Investigator shall be supported in the execution of the Clinical investigation by the healthcare and non-healthcare personnel and by any contractors engaged by the Entity, as appointed by the Entity and operating under its responsibility for all aspects pertaining to this Clinical investigation, who are qualified to conduct the Clinical investigation, and who have previously received adequate training as provided for in the applicable laws, by the Sponsor/CRO and who have declared their willingness to take part in the Clinical investigation (the Co-investigators). Without affecting the foregoing, the definition of “Investigators” does not include any medical or non-medical personnel who perform proprietary institutional activities in the context of the Clinical investigation (for example pharmacists, IT technicians).