Easily Delete Date into the Clinical Trial Agreement

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How to Delete Date 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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What is the deadline for entering data on a required clinical trial?

All Applicable Clinical Trials are required to report results within 1 year of the date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical study concluded ing to the pre-specified protocol or was terminated

When should a clinical study report be submitted?

IND application must submit annually (i.e., within 60 days of the anniversary of the date that the IND was initially accepted by the FDA) an Annual Report to the IND application/FDA. The Annual Report must include a written summary of the status of all clinical studies being conducted under the IND application.

How long is clinical trial data kept?

HIPAA Requirements: Any research that involved collecting identifiable health information is subject to HIPAA requirements. As a result records must be retained for a minimum of 6 years after each subject signed an authorization.

What is the time frame for clinical trials?

There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage.

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.

How often should the record verification date be updated?

In general, the Responsible Party must review and update, as necessary, an active study record at least once every 12 months. Failure to do so will result in the record being identified as having a problem that needs to be addressed.

What is the final rule for clinical trial registration and results information submission?

In general, the final rule requires the submission of results information not later than 1 year after the completion date (referred to as the primary completion date) of the clinical trial, which is defined as the date of final data collection for the primary outcome measure (81 FR 64983).

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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