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How to notarize 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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Who signs the clinical trial agreement?

Parties to clinical trial or study agreements include the participating site, the study sponsor, and/or the relevant clinical research organization (CRO).

Who has the responsibility for approving the conduct of a clinical trial?

A Principal Investigator (PI) is the person in charge of conducting a clinical trial. The PI is responsible for ensuring that the study is following all regulatory requirements and meeting the internationally recognized standards for Good Clinical Practice (GCP).

What are the components of a clinical trial agreement?

A clinical trials agreement should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract

Who approves clinical trial protocol?

Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.

What is included in a clinical trial agreement?

A clinical trials agreement should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract

Who approves clinical trials before they begin?

Clinical trials advance through four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.

What is a CTA agreement?

Contractor Team Arrangement means a Federal Supply Schedule Contractor Team Arrangement (CTA) where an arrangement is established between two or more Schedule contractors who work together to meet agency requirements.

Is a clinical trial agreement the same as a contract?

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.

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