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.
Conduct of Study a) The Institution and the Investigator hereby agree to conduct the Study in accordance with this Agreement and the Protocol. The Institution and the Investigator shall also follow PSI’s and/or the Sponsor’s instructions as they relate to the Institution’s and/or the Investigator’s performance under this Agreement.
Conduct of Study. Protocol 1.1
Conduct of Study. A. 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, state, federal, and national laws and a právní předpisy týkající se hlášení všech poplatků a jiných výdajů placených zdravotníkům
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.
Conduct of Study. Institution further agrees that in the performance of the Study their employees and agents shall:
Conduct of Study. The contractor agrees to perform a study (the "Study") of the test kit (the "Test Kit") as described in the study protocol attached to this Agreement as Exhibit A (the "Protocol"), subject to the terms and conditions of this Agreement, including those attached to this Agreement as Exhibit B, and in a manner consistent with the most current Good Laboratory Practices Standards and requirements, or other governmental agencies which have jurisdiction over Contractor's laboratory facility or the Study. The Protocol may not be modified except by agreement between Contractor and Sponsor, which agreement must be in writing. Contractor shall, in any event, promptly notify Sponsor in writing of any such emergency change that has been agreed to by Contractor and Sponsor. If, during the Study, Sponsor and Contractor develop additional protocols or changes to the Protocol that are to govern the conduct of the Study, Sponsor and Contractor shall execute an addendum to Exhibit A stating the terms of the changes to the Protocol or such additional protocol.
Conduct of Study. 19.301 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. A. 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:
Conduct of Study. (a) Institution shall conduct and shall require Principal Investigator, subinvestigator(s), and Institution’s other employees, subcontractors and agents performing work in connection with the Study (collectively, “Institution Personnel”) to conduct the Study in accordance with: (i) this Agreement and the relevant Statement of Work; (ii) the IRB-approved Protocol; (iii) all reasonable written instruction provided by or on behalf of Pharmacyclics; (iv) Institution’s ethical standards and/or policies; and (v) all applicable federal, state and local laws and regulations and guidelines (collectively, “Law(s)”), including without limitation (and each to the extent applicable to a Study), anti-bribery and anti-corruption laws, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E6 Good Clinical Practice as adopted by the FDA (“ICH-GCP”), regulations of the United States Food and Drug Administration (the “FDA”), the Patient Protection and Affordable Care Act of 2010, the Medicare/Medicaid Anti- kickback statute, the Social Security Act of 1935, the Controlled Substances Act, data protection and privacy laws, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and the Federal Food, Drug and Cosmetic Act of 1938, as each may be amended, from time to time. In furtherance of the foregoing obligations, Institution shall ensure that an Institution Review Board (“IRB”) established and constituted in accordance with applicable Laws approves and oversees the conduct of the Study prior to the commencement of the Study. Institution will comply with the instructions of the IRB respecting the conduct of the Study, and will notify Pharmacyclics to the extent any such instructions vary from the Protocol.
