Easily Replace Date Field into the Clinical Trial Agreement

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How to Replace Date Field into 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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Should any change or correction to a CRF be dated initialed and explained if necessary and should not?

Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e., an audit trial should be maintained); this applies to both written and electronic changes or corrections (see section 5.18.

Is the investigator or person designated by the investigator is only required to document and explain docHub deviations from the approved protocol?

The investigator, or person designated by the investigator, should document and explain any deviation from the approved protocol. The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s) to trial subjects without prior IRB approval.

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 is the difference between primary completion date and study completion date in clinical trial?

Primary Completion Date: the date that the last data point for the primary outcome measure was collected from the last enrolled participant. Study Completion Date: the date that the last data point for all remaining outcome measures was collected from the last enrolled participant.

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 do GCP principles stipulate regarding emergency situations when prior consent of the subject is not possible?

In emergency situations, when prior consent of the subject is not possible, the consent of the subjects legally acceptable representative, if present, should be requested.

When should an investigator brochure be updated?

The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.

How do you keep up to date with clinical trial best practices?

3 tips for staying up to date on current medical practices Attend networking conferences. An effective way to learn about the latest therapies is to attend conferences. Read peer-reviewed research. To be valuable, medical research must be verifiable. Seek out expert-curated content.

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