Link line in the Clinical Trial Agreement Template effortlessly

Aug 6th, 2022
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How to Link line in the Clinical Trial Agreement Template

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um Im excited today to kick off the fall clinical trials toolkit series um our first one is the office of sponsored programs clinical trial agreement review and negotiation um today we have Rachel humberson she is the interim assistant director um from research office and office of sponsored programs and we also have um Julie even though I practiced it Julie Im going to mess it up Anna okay is that right yeah okay she is a negotiator with research with the research office and office of sponsored programs um before I read their um their bios and a fun fact about them again we are offering continuing education to WVU employees so if um you would like CES please indicate that and please put your name um an email address in the chat so for attendance purposes um Im trying to think if theres anything else oh if you have a question during this um feel free to put it in the chat well be watching it and um I will stop Rachel and Julie and let them know what your question is and then also

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Definition. A clinical trial agreement (CTA) or clinical study agreement (CSA) is a legally binding agreement that governs the conduct of a particular study and sets forth the obligations of each party to the agreement.
Study protocols PROSPERO. PROSPERO is an international database containing protocols of systematic reviews with a health-related outcome. Find more information about PROSPERO here. ClinicalTrials.gov. ClinicalTrials.gov is a database of clinical studies conducted around the world.
If the clinical study is funded in whole or in part by a U.S. Federal Government agency, the complete grant or contract number must be submitted as a Secondary ID. Unique Protocol ID: Any unique identifier (ID) assigned to the protocol by the sponsor. At JHM, the Unique Protocol ID is the IRB number.
The Trial Site will permit the Sponsor and CRO to examine the conduct of the Clinical Trial and the Investigator Site upon reasonable advance notice during regular business hours to determine that the Clinical Trial is being conducted in ance with the Protocol, ICH-GCP and the applicable regulatory requirements.
The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.
Clinical Trial Agreement (CTA) Description of the Project. Sponsor, CRO (Contract Research Organization) and Site Responsibilities. Publication and Intellectual Property Terms. Indemnification and Insurance. Recording Keeping and Inspection. Guidelines for Dispute Resolution. Grounds for Contract Termination.
(PROH-tuh-KOL) A detailed plan of a scientific or medical experiment, treatment, or procedure. In clinical trials, it states what the study will do, how it will be done, and why it is being done.

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