Easily Replace Date Field from the Clinical Trial Agreement

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How to Replace Date Field 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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What is the difference between primary completion date and study completion date?

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 is study start date in clinical trials?

Trial dates The start date is the actual date on which the first participant was enrolled in a clinical trial. The estimated start date is the date that the researchers think the trial will start.

What are all the protocols designed to release a clinical trial?

Clinical Trial Protocol Development Title Page (General Information) Background Information. Objectives/Purpose. Study Design. Selection and Exclusion of Subjects. Treatment of Subjects. Assessment of Efficacy. Assessment of Safety.

Which of the following is the final regulatory authority for the approval of clinical trials regulatory in India?

The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in the country.

What are the GCP requirements regarding the informed consent process?

The informed consent form, which is a legal document, must include 20 ICH-required elements (section 4.8. 10 of the GCP guidance). They include the purpose, duration, risks, benefits, costs and additional expenses of the trial; a description of the trial procedures; alternative care options; and volunteers rights.

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.

When should a clinical study report be submitted to the FDA?

The applicant should submit a requested abbreviated or full study report within 60 days of receiving a request (30 days for priority applications).

What are the regulatory deadlines by which protocol registration or result summary data must be released into PRS for quality control QC review?

ClinicalTrials.gov Quality Control (QC) Review Process To remain compliant, records must be edited to address issues identified by ClinicalTrials.gov notification within 15 calendar days for protocol/registration records and within 25 calendar days for records with results.

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