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Remove Mandatory Field to the Clinical Trial Agreement

Remove Mandatory Field to the Clinical Trial Agreement and eSign it in minutes

Aug 6th, 2022

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How to Remove Mandatory Field to the Clinical Trial Agreement

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41 votes

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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Got questions?

Below are some common questions from our customers that may provide you with the answer you're looking for. If you can't find an answer to your question, please don't hesitate to reach out to us.

Can you be forced to participate in a clinical trial?

The consent form is usually a paper or online document that you must read and sign before enrolling. The consent form is required to include information about the following topics: The fact that your participation is voluntary. No one can force you to participate in a research study.

Who has the authority to terminate a clinical trial for the entire study or at a given site?

Who Can Terminate or Suspend a Clinical Trial? Termination or suspension of a clinical trial, whether in its entirety or at a specific CRS may be implemented by any applicable Regulatory Entity (RE)/Regulatory Authority (RA), Institutional Review Board (IRB)/Ethics Committee (EC), or DAIDS.

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.

What document is mandatory to enroll subject in clinical research study?

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

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