Study Conduct. Licensee shall conduct Clinical Trials in compliance with Applicable Law and regulatory standards, including, as applicable, those relating to Good Laboratory Practices (“GLP”), Good Clinical Practices (“GCP”), pharmacovigilance and safety reporting, and requirements for the protection of human subjects.
Study Conduct. 2.1 MD Xxxxxxxx and Sponsor will each use its own facilities and its reasonable best efforts to conduct its respective obligations in the performance of the Study, in accordance with Exhibit A and applicable laws and regulations. For MD Xxxxxxxx, the Study shall be performed under the direction of Xxx Xxxxx, M.D., Ph.D., or his/her successor as mutually agreed to by the Parties (the “Principal Investigator”). In the event of any conflict between Exhibit A and this Agreement, this Agreement shall control. MD Xxxxxxxx shall provide all necessary personnel, equipment, supplies, facilities and resources to perform MD Anderson’s obligations in the Study, and shall be fully responsible for the activities of any MD Xxxxxxxx personnel to whom Study activities are delegated. Sponsor shall provide all necessary personnel, equipment, supplies, facilities and resources to perform Sponsor’s obligations in the Study, and shall be fully responsible for the activities of any Sponsor’s personnel to whom Study activities are delegated.
Study Conduct. CRO shall conduct the Services of each IPA in accordance with the applicable provisions each Study protocol, agreed SOPs, the current Guidelines for Good Clinical Practices for Trials (“GCP Guidelines”), and all applicable local, state, and federal laws and regulations governing the performance of clinical investigations including, but not limited to, the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration (“FDA”) and the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and regulations of the Department of Health and Human Services (“HHS”).
Study Conduct. 2.1 MD Xxxxxxxx will use its own facilities and its reasonable best efforts to conduct the Study under the direction of Xx. Xxxx Xxxxxxx, or his/her successor as mutually agreed to by the Parties (the “Principal Investigator”) in accordance with Exhibit A and applicable laws and regulations. In the event of any conflict between Exhibit A and this Agreement, this Agreement shall control. Unless expressly set forth herein, MD Xxxxxxxx shall provide all necessary personnel, equipment, supplies, facilities and resources to perform the Study, and shall be fully responsible for the activities of any MD Xxxxxxxx personnel to whom Study activities are delegated.
Study Conduct. (a) Institution agrees to conduct any Study in strict compliance with:
Study Conduct. 3.1 Antigen Express’s willingness to provide the Study funding and supply the Antigen Express Study Drug pursuant to this Agreement is predicated upon (a) its review of, and the mutual agreement of the Parties with respect to, the Protocol; (b) Subject enrollment and Study progress in accordance with Appendix B, and (c) the terms and conditions of this Agreement.
Study Conduct. (All studies) a) Ensure that the Study is managed according to GCP (as defined in the Protocol), all relevant legislation, and the Protocol ✓ [Sponsor’s Protocol Reference Number], [Name of Site Principa1l Investigator] NHS-ABPI-BIA model Clinical Trial Agreement 2011 -– England – (DRAFT revision 2015 v0.4) RESPONSIBILITY to: Sponsor Trust If ACTIVITY is delegated, name the body / individual delegated to: b) Ensure that the Study is conducted locally according to GCP, all relevant legislation, and the Protocol ✓
Study Conduct. Principal Investigator will conduct the Study in accordance with the Protocol, ABC written instructions, International Conference on Harmonization Good Clinical Practice (ICH GCP) guidelines, and all applicable governmental laws, rules, and regulations.
Study Conduct. 2.1. The Sponsor with the Institution has designated the Principal Investigator to recruit patients into, and participate in the Study as a Study site. The Institution assures that the Principal Investigator has sufficient authority, competence, and experience in clinical trials, as well as medical and scientific skills to participate in this Study, according to any legal and health applicable requirements. The Institution and the Principal Investigator will use their best efforts to recruit approximately . patients. The parties agree that the increase of the number of patients to be enrolled at the Institution will require written approval from the Sponsor, but not an amendment to this Agreement. Patient enrolment will stop when the total number of patients as specified in the Protocol has been recruited between participating sites. 2.2. The Institution and the Principal Investigator will take part in the Study, collect the necessary information and communicate such information to the CRO, in compliance with the terms of the Protocol, which is attached in Appendix 1 of this Agreement and all its amendments. 2.3. The Institution undertakes to create all necessary conditions allowing for the Zdravotnické zařízení bere na vědomí a souhlasí, že mezi CRO a hlavním zkoušejícím bude uzavřena separátní smlouva týkající se finanční odměny hlavního zkoušejícího a personálu zapojeného do studie (dále jen „Finanční dohoda”). Povinnosti hlavního zkoušejícího týkající se provádění studie budou uvedeny zejména v této smlouvě. 1. Úvod Zadavatel má zájem, aby zdravotnické zařízení a hlavní zkoušející realizovali tuto neintervenční studii (tak jak je xxxxxxx xxxxx xxxxxx 0x směrnice 2001/20/ES). 2.
Study Conduct. (All studies) a) Ensure that legislation in relation to research is followed within the Site NHS Organisation
