Easily Replace Field Validation in the Clinical Trial Agreement

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How to Replace Field Validation 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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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.

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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.

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.

What is data validation in clinical trials?

Data validation is the process of testing the validity of data in ance with the protocol specifications. Edit check programs are written to identify the discrepancies in the entered data, which are embedded in the database, to ensure data validity.

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.

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.

What is the difference between analytical validation and clinical validation?

ANALYTIC VALIDATION VERSUS CLINICAL VALIDATION Analytic validity focuses on the analyte(s) targeted by the assay, whereas clinical validity focuses on the associated diseases or patient conditions.

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 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.

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