Easily Hide Date in the Clinical Trial Agreement

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How to Hide Date 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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What is the privacy rule in clinical trials?

The Privacy Rule is a response to public concern over potential abuses of the privacy of health information. The Privacy Rule establishes a category of health information, referred to as PHI, which may be used or disclosed to others only in certain circumstances or under certain conditions.

Should clinical trial data be public?

Clinical trial transparency is important for patients, clinicians, researchers, clinical trial participants, and the public at large for numerous reasons. Sharing sensitive clinical trial data should always follow the guidelines laid out by regulatory authorities.

What is the study completion date?

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

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

Is clinical trial data confidential?

Confidentiality in clinical research in the US is covered by the Privacy Rule that are a set of regulations provided by the department of health and human services (HSS) as a response to a congressional mandate in the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Is clinical trial data published?

The vast quantities of data collected throughout a clinical trial may result in several publications, depending on the scope of the paper, article, conference presentation, or other work.

Is clinical trial data subject to HIPAA?

For example, sponsored clinical trials conducted by a physician or at a hospital that submit data to the U.S. Food and Drug Administration may involve PHI and are therefore subject to HIPAA regulations.

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.

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Hide Date in the Clinical Trial Agreement