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How to Protect Clinical Trial Agreement Template

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In this video tutorial, the fall clinical trials toolkit series is introduced, focusing on the Office of Sponsored Programs (OSP) clinical trial agreement review and negotiation. The session features Rachel Humberson, the interim assistant director from the research office, and Julie, a negotiator with the OSP. The presentation offers continuing education credits for WVU employees, who are encouraged to provide their names and email addresses in the chat for attendance. Viewers are invited to ask questions throughout the session, which will be relayed to the speakers as needed.

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Who are the parties to a CTA?

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.

Who is responsible for participant safety in clinical trials?

Today, every clinical investigator is required to monitor and make sure that every participant is safe. These safeguards are an essential part of the research.

How is the safety of the participants protected?

Institutional Review Board The IRBs purpose is to ensure that clinical trials are ethical and that the participants rights are protected. The IRB reviews the trials protocol before the study begins. An IRB will only approve research that deals with medically important questions in a scientific and responsible way.

What aspects of a clinical trial agreement can help protect study volunteers that participate in clinical trials?

Informed consent must be obtained. The consent language agreed to, and the process for obtaining consent, must be carefully documented. Research subject privacy and confidentiality must be adequately protected. The ongoing safety of research subjects must be adequately monitored.

How can you protect research participants from harm?

In order to minimising the risk of harm you should think about: Obtaining informed consent from participants. Protecting the anonymity and confidentiality of participants. Avoiding deceptive practices when designing your research. Providing participants with the right to withdraw from your research at any time.

How do you protect participants in clinical trials?

To protect participants confidentiality, you should encrypt computer-based files, store documents (i.e., signed consent forms) in a locked file cabinet and remove personal identifiers from study documents as soon as possible.

How do I protect my participant privacy?

6 Best Practices for Protecting Participant Data in User Research Establish a data-management process. Develop a data-collection plan for preserving participants confidentiality. Informed Consent. Maintain participant anonymity. Share files in a secure way with only those people who need them.

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

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