Easily Delete Required Fields in the Clinical Trial Agreement

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How to Delete Required Fields in 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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Which of the following documents must be available to the study team throughout the clinical trial that is studying a new investigational product?

The essential documents for clinical trials are the following: Investigators Brochure. Clinical Study Protocol. Subject Information and Informed Consent Form.

What are the components of a clinical trial agreement?

A CTA 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 and possibility of

What are the GCP requirements regarding the informed consent process?

The informed consent form, which is a legal document, must include 20 ICH-required elements (section 4.8. 10 of the GCP guidance). They include the purpose, duration, risks, benefits, costs and additional expenses of the trial; a description of the trial procedures; alternative care options; and volunteers rights.

What is GCP requirements?

GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of institutional review boards, clinical research investigators, clinical trial sponsors, and monitors. In the pharmaceutical industry monitors are often called clinical research associates.

What are the 3 main GCP principles?

Three principles of equal importance associated with basic ethics, particularly recognized for persons, beneficence, and justice, permeate all other GCP principles.

What are the requirements for the informed consent process?

The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research.

What is informed consent in GCP?

Informed consent involves providing a potential participant with: adequate information to allow for an informed decision about participation in the clinical investigation. facilitating the potential participants understanding of the information.

What is a Section 801 clinical trial?

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) refers to a federal statute established in 2007 requiring the registration and reporting of information on applicable clinical trials on Clinicaltrials.gov.

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