Conduct of Study. 1.2.1 The Parties shall conduct the Study in accordance with the Protocol and its amendments, the terms of this Agreement, and the terms and conditions of the approval of relevant authorities. Institution/Principal Investigator shall adhere to separate manuals and specific procedures provided by Sponsor applicable for conducting the Study.
1.2.2 Institution/Principal Investigator shall be fully informed of the Protocol and the Study Product. Sponsor shall provide all relevant clinical pharmacology and toxicology information and advice to Institution/Principal Investigator, which are required for the proper planning and conduct of the Study. Such information will include the Investigator's Brochure (IB) and information on Suspected Unexpected Serious Adverse Events (SUSARs) for unlicensed products or the Summary of Product Characteristics (SPC) for licensed products. Principal Investigator shall attend, or ensure a delegate attends, all Investigators’ meetings for the Study from time to time as reasonably required by Sponsor.
1.2.3 Institution/Principal Investigator shall ensure that all the Institution's employees and collaborators, who are involved in the Study fully, understand and adhere to the Protocol and the obligations of both the Institution and the Principal Investigator.
Conduct of Study. Protocol 1.1
Conduct of Study. The Study will be conducted in accordance with applicable laws, rules, and regulations governing the conduct of clinical trials and pertaining to investigational drugs, generally accepted good clinical practice and the conditions specified in the Statement of Investigator, U.S. Food and Drug Administration (“FDA”) Form 1572, as described in 21 Code of Federal Regulations (“CFR”) 312.53, which Institution and Principal Investigator shall have signed and Institution shall have returned to Sponsor prior to the commencement of the Study. Institution acknowledges and agrees that it is responsible for (A) the actions, performance, and conduct of the Principal Investigator, and (B) Principal Investigator’s compliance with all of Principal Investigator’s obligations set forth in this Agreement. Any failure by the Principal Investigator to perform or satisfy an obligation herein shall be considered a breach of this Agreement by Institution. Institution agrees to use its reasonable efforts to ensure that the Principal Investigator complies fully with the terms of the Protocol. In the performance of the Study the Institution specifically represents that it shall, and shall require the Principal Investigator and all employees engaged in the performance of the Study to:
a. Exercise independent medical judgment as to the compatibility of each patient with Protocol requirements;
b. Obtain from each patient in the Study and before the Study subject begins participating in the Study a signed informed consent form in a form which has been approved by the IRB/EC and reviewed and approved by Sponsor in accordance with the Protocol and with 21 CFR Part 50 and/or the International Conference on Harmonisation Guidelines for Good Clinical Practice as adopted by the FDA (“ICH GCPs”), as applicable Institution will allow Sponsor and/or their respective designees to inspect signed informed consent forms or make photocopies thereof during monitoring visits or audits conducted in accordance with the terms of this Agreement ;
c. Properly perform and direct the Study in accordance with applicable laws, the Protocol and ICH GCPs and FDA GCPs;
d. Ensure that all advertising, recruitment, and training materials developed by Institution, Principal Investigator, or any of Institution’s employees, affiliates or agents in connection with the Study will comply with the Protocol, as well as all applicable laws, regulations, codes and rules, and receive prior review and approval by Sponsor and th...
Conduct of Study. 2.2.1 The Parties shall conduct the Study in accordance with the Protocol and its amendments, the terms of this Agreement, and the terms and conditions of the approval of relevant authorities.
2.2.2 Institution/Principal Investigator shall adhere to separate manuals and specific procedures provided by Sponsor applicable for conducting the Study.
2.2.3 Institution/Principal Investigator shall be fully informed of the Protocol and the Study Product and attend, or ensure a delegate attends, all Investigators’ meetings for the Study from time to time as reasonably required by Sponsor.
2.2.4 Institution/Principal Investigator shall ensure that all the Institution's employees and collaborators, who are involved in the Study fully, understand and adhere to the Protocol and the obligations of both the Institution and the Principal Investigator.
2.2.5 Sponsor shall provide all relevant clinical pharmacology and toxicology information and advice to Institution/Principal Investigator, which are required for the proper planning and conduct of the Study. Such information will include the Investigator's Brochure (IB) and information on Suspected Unexpected Serious Adverse Events (SUSARs) for unlicensed products or the Summary of Product Characteristics (SPC ) for licensed products.
Conduct of Study. Protocol 1.1 Realizácia Štúdie/Protokol
a) The Institution hereby agree to conduct the Study in accordance with this Agreement and the Protocol.
a) Inštitúcia týmto súhlasí s realizáciou Štúdie v súlade s touto Zmluvou a Protokolom.
b) The Study shall be conducted athematology departments, X.
Conduct of Study. The Site shall, and shall ensure that its employees and agents shall, conduct the Study in strict compliance with any and all applicable federal, national, state, local or other jurisdictional laws, rules, regulations, policies, guidelines, guidances, and governmental requirements, as may be applicable to the Parties, Study Personnel, and/or the Study (“Applicable Law”), including without limitation: i. all applicable rules, policies, or guidance issued by the European Medicines Agency (“EMA”); ii. the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Guidelines for Good Clinical Practices as adopted or issued by any governmental or other regulatory authority, including FDA and EMA (collectively, “GCP” or “GCP Guidelines”), iii. all applicable laws and regulations regarding the protection of privacy, personal data, and medical data, including the European Data Protection Directive (95/46/EC) (collectively, the “Privacy Regulations”); iv. all applicable state HIV testing laws; v. all applicable local,
Conduct of Study. Institution further agrees that in the performance of the Study their employees and agents shall:
i. Obtain from each Study subject a signed consent form (“Informed Consent Form”) in accordance with the Protocol and template informed consent form which has been approved by the IRB in accordance with 21 CFR §56, et, seq., or any successor thereto.
ii. Perform the Study with reasonable care, diligence and skill and ensure that personnel participating in the Study are competent and have appropriate professional qualifications, training and experience.
iii. Promptly notify the IRB of any failures to comply with the Protocol ( deviation where necessary to eliminate an immediate hazard(s) to Study subjects or from the Protocol arising out of medical necessity for Study subject safety shall not be deemed a failure to adhere to the Protocol),
iv. Maintain complete and accurate records of the status and progress of the Study as required by the Protocol and with sufficient legibility and detail for use by regulatory agencies (“Study Records”). The Study Records shall include: case report forms; records reflecting the receipt and disposition of the Study Drug, including all dates, quantity and use by Study subjects; Study safety data required by the Protocol; records of Study subject identification; and clinical observations and laboratory tests as required in the Protocol.
v. Institution will notify AIM within two (2) business days of receiving FDA authorization to initiate the Study.
vi. Institution shall notify AIM within two (2) business days of when first treatment of Study Drug is administered and when first combination cohort Study Drug plus IntronA is administered pursuant to the Protocol. However, Institution is obligated to confirm in a confidential communication whether any dose-limiting toxicity was observed in the initial cohort before implementing the combination cohorts. For the avoidance of doubt, such communication shall be treated as Confidential Information, ( as defined below) by the Parties
Conduct of Study. 301 The study will be conducted jointly by the association and the district. Results will be approved by the parties within fifteen (15) working days of completion of the study.
Conduct of Study. 1.2.1 The Parties shall conduct the Study in accordance with the Protocol and its amendments, the terms of this Agreement, and the terms and conditions of the approval of relevant authorities. Institution/Investigator shall adhere to separate manuals and specific procedures provided by Sponsor applicable for conducting the Study.
1.2.2 Institution/Investigator shall be fully informed of the Protocol. Sponsor shall provide all relevant clinical pharmacology and toxicology information and advice to Institution/Investigator, which are required for the proper planning and conduct of the Study. Investigator shall attend, or ensure a delegate attends, all Investigators’ meetings for the Study from time to time as reasonably required by Sponsor.
1.2.3 Institution/Investigator shall ensure that all the Institution's employees and collaborators, who are involved in the Study fully, understand and adhere to the Protocol and the obligations of both the Institution and the Investigator.
Conduct of Study. Simbec agrees to conduct the study in strict accordance with the study protocol and in compliance with the applicable International Committee of Harmonization guidelines, United Kingdom Medicines Control Agency guidelines, Good Clinical Practice and the United States Food and Drug Administration's Code of Federal Regulations section 21, parts 50 and 56. Simbec agrees to maintain complete records of the disposition of study drug, including dates and quantities used by the subjects. Simbec agrees to prepare and maintain complete and accurate case histories to record all observations and other data pertinent to the study on each study subject.
