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.
Appears in 9 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
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 ProductDrug. 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, fully understand and adhere to the Protocol and the obligations of both the Institution and the Principal Investigator.
Appears in 2 contracts
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 ProductDrug. 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 that a delegate attends, all Investigators’ investigator 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, fully understand and adhere to the Protocol and the obligations of both the Institution and the Principal Investigator.
Appears in 1 contract
Samples: Clinical Trial Agreement
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 Site Investigator shall adhere to separate manuals and specific procedures provided by Sponsor applicable for conducting the Study.
1.2.2 Institution/Principal Site 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 Site 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 Site 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 Site Investigator shall ensure that all the Institution's employees and collaborators, who are involved in the Study fully, fully understand and adhere to the Protocol and the obligations of both the Institution and the Principal Site Investigator.
Appears in 1 contract
Samples: Clinical Trial Agreement