Easily Replace Option Choice in the Clinical Trial Agreement

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How to Replace Option Choice 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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What is an addendum or amendment or appendix?

An appendix supplements the body of a document, providing detailed information that not everyone will want to read. Appendices are often statistical, historical or technical. An addendum is extra information that the writer discovered after writing the report, such as a new study on the topic.

What is replacement of subjects in clinical trials?

If a subject does not take at least 17 doses in the first cycle, the subject will be replaced because he/she has not taken enough drug to confirm safety at that dose level.

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 is the difference between an addendum and an amendment clinical trials?

An amendment is typically used to change something thats part of an original contract. Think of amendments as modifications to the earliest agreement (for example, altering an agreed-upon deadline). An addendum is used to clarify and add things that were not initially part of the original contract or agreement.

What is difference between amendment and addendum?

An amendment is typically used to change something thats part of an original contract. Think of amendments as modifications to the earliest agreement (for example, altering an agreed-upon deadline). An addendum is used to clarify and add things that were not initially part of the original contract or agreement.

What is a CTA in a clinical trial?

Definition. 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.

What is an amendment in research?

Amendments are changes made to the research after review body approval has been given. The following sections provide information about each review bodys requirements and, where appropriate, guidance about how different types of amendments are handled by that review body.

Whats the difference between an addendum and an amendment quizlet?

Whats the difference between an addendum and an amendment? An addendum is attached to a contract to create additional terms, and an amendment changes the terms within an existing contract.

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