Regulatory

UNC Network for Research Professionals (NRP) The UNC-NRP is a peer group that is open to all research personnel on campus to help increase awareness and communication of best practices through a series of educational...

Education & Training

All clinical trials supported by the NC TraCS Institute are required to have a Data and Safety Monitoring Plan (DSMP). The DSMP may vary from simple to more detailed, depending on the level of risk imposed on the research...
Human Subjects and Clinical Trial Information We provide expertise and guidance on completion of the human subjects and clinical trial information forms required for NIH grant submissions. Guidance documents, forms, templates...
DSMB Meeting Dates and Submission Deadlines DSMB Meeting Dates and Submission Deadlines 2023 Meeting DatesSubmission Deadlines December 20, 2023 December 8, 2023 2024 Meeting DatesSubmission...
All investigators conducting a research study through the TraCS Institute have a responsibility to report problems or adverse events that occur during the research to the IRB (OHRE). Adverse Event Reporting All investigators...
ClinicalTrials.gov is a public registry of clinical trials maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). The clinicaltrials.gov website is designed to provide patients, health...
UNC Investigators who hold an IND (investigator-sponsor) have an obligation for monitoring of the research protocol: The sponsor shall monitor the progress of all clinical investigations being conducted under its IND (21...
FORM 1571 – Used only for IND studies: This form must accompany the initial IND submission. It will contain serial number 0000 for the initial submission. This form is required to accompany all subsequent submissions to the...
One component of a Safety Monitoring Plan may consist of an independent Data and Safety Monitoring Board or Committee. An independent Data and Safety Monitoring Board (DSMB) is required by NIH Guidelines for all Phase III clinical...
For clinical research studies directed at evaluating the safety and/or effectiveness of an unapproved device, the prior submission of an Investigational Device Exemption (IDE) is required if the reviewing institutional review...
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