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Replace Text Box from the Clinical Trial Agreement

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Aug 6th, 2022

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How to Replace Text Box from 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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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.

What are the essential documents for clinical trials?

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

What are the main requirements for a clinical trial?

Clinical Trial Requirements Consent Form Posting Requirement. Good Clinical Practice Training. Registration and Reporting of Clinical Trial Results.

What is the most important regulatory document in clinical trial?

The Form FDA 1572, otherwise known as the Statement of Investigator, is one of the most important documents in a clinical trial because it shows the sponsor that the PI (principal investigator) will comply with all FDA regulations.

What are the essential documents to be generated after completion or termination of the clinical trial?

DOCUMENTS NEEDED AFTER COMPLETION OR TERMINATION OF A CLINICAL TRIAL. Following completion of a trial, a comprehensive clinical study report (CSR) must be written that provides a detailed description of the results of the study, whether positive or negative.

What is a clinical trial agreement?

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.

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.

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