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How to Replace Arrow to the Clinical Trial Agreement

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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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What is the clinical trial agreement?

A Clinical Trial Agreement (CTA) is a legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and /or proprietary information and the institution that may be providing data and/or results, publication and input into further

What does the CTAs confidentiality clause describe?

From the Sponsors perspective, then, the confidentiality clause in a CTA should prohibit the Site, Principal Investigator, and Study Personnel from using or disclosing the Sponsors Confidential Information, except as may be permitted by the CTA or as required by law.

Who signs clinical trial agreement?

A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines each partys responsibilities and obligations for the clinical trial.

What is an accelerated clinical trial agreement?

The Accelerated Clinical Trial Agreement (ACTA) was prepared with the intent to facilitate relationships with industry sponsors that are interested in expediting the contract process, thus optimizing lag time for research.

What is a CTA in pharma?

A Clinical Trial Application (CTA) is a submission to the competent National Regulatory Authority(ies) for obtaining authorization to conduct a clinical trial in a specific country. It is an application with necessary information on investigational medicinal products.

What is the purpose of a clinical trial agreement?

CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each partys responsibilities and obligations for the clinical trial.

What is an accelerated clinical trial?

An accelerated clinical trial agreement is a standard legal agreement between parties that allows for multi-site clinical trials to take place faster and can help avoid delays usually involved in a contract process.

What is a CTA agreement?

Contractor Team Arrangement Agreement means the written agreement between team members detailing the responsibilities of the team and each team member. Team Leader means the contractor who has been designated as the leader and whose responsibilities have been outlined in the CTA Agreement.

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