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How to Save Clinical Trial Agreement in PPR

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The video tutorial introduces the fall clinical trials toolkit series, beginning with a focus on the clinical trial agreement review and negotiation by the Office of Sponsored Programs. The presenters are Rachel Humberson, the interim assistant director of the research office, and Julie, a negotiator from the same office. The session offers continuing education credits for WVU employees, who are encouraged to provide their names and emails for attendance. Participants can also ask questions via the chat, which will be relayed to the speakers. The session aims to provide valuable insights into clinical trial agreements.

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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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How long does research data need to be kept Canada?

It is up to the researcher to determine for how long the study data should be retained. Any clinical trial with Health Canada oversight must retain the study information for 25 years. Apart from that legal requirement, it is a personal decision of the researcher.

What is the difference between primary completion and study completion?

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 long does clinical data need to be kept?

Federal regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46) and UVA regulations require that data are kept for at least 5 years. Additional standards from your discipline may also be applicable to your data storage plan.

Which documents should be generated after completion or termination of the clinical trial?

DOCUMENTS NEEDED AFTER COMPLETION OR TERMINATION OF A CLINICAL TRIAL. Following completion of a trial, a comprehensive clinical study report (CSR) must be written that provides a detailed description of the results of the study, whether positive or negative.

How long does clinical trial data need to be kept?

Federal regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46) and UVA regulations require that data are kept for at least 5 years. Additional standards from your discipline may also be applicable to your data storage plan.

How long does FDA require storage of trial related records?

An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication

How do I download a protocol from Clinicaltrials gov?

Click on the Download button directly beneath the Select file format drop-down menu to save this file to your computer. For Advanced Users - Download XML Study Record Content. Note: It may take several minutes to download a large number of studies.

What is the required archiving period for data generated from clinical analysis?

The EC(s) should archive all documents and records for an amount of a minimum of 5 years once the completion or termination of a trial.

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