Easily Replace Text Fields to the Clinical Trial Agreement

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How to Replace Text Fields 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 applicable clinical trial under Fdaaa?

Applicable Clinical Trial (ACT) is the term used in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PL 110-85) to designate the scope of trials that may be subject to the registration and reporting requirements in FDAAA.

How do you update clinical trials?

Editing and Updating a Record [Requires a browser that supports HTML5.] At any time, you can make updates and edits to a record published on ClinicalTrials.gov by logging into the Login to ClinicalTrials.gov PRS and clicking on Edit Record under the Protocol Records heading on the PRS main menu.

What are clinical trial agreements?

A clinical trial agreement (CTA) or clinical study agreement (CSA) is a legally binding agreement that governs the conduct of a particular study and sets forth the obligations of each party to the agreement.

Who are the parties to a 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).

Do clinical trial results have to be published?

The WHO also has requirements for publishing clinical trial data: results must be published open access within 12 months in a peer-reviewed journal or made publicly available within 24 months, and they must be posted on a clinical trial registry within 12 months.

How often should the record verification date be updated?

Record Verification Date Any time the Responsible Party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time.

What is clinical update?

Clinical Updates means material information and developments with respect to each Clinical Trial, including, without limitation, any serious adverse event in any Clinical Trial.

How often does ClinicalTrials.gov need to be updated?

Required Updates to a ClinicalTrials.gov Record In general, the Responsible Party must review and update, as necessary, an active study record at least once every 12 months. Failure to do so will result in the record being identified as having a problem that needs to be addressed.

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