Author Archives: Jeanne Lovmo

We have updated the SOM CRSO policy webpage to include a Policy Matrix that identifies core clinical research policies, standards, and procedures that pertain to UNC-Chapel Hill (“University”) and UNC Health to make it easier for clinical research personnel to find and review relevant information.

The CRSO is excited to announce that the following new and revised SOPs will be issued today for the SOM clinical research community and posted in the Clinical Research Profile and Training System (PaTS). The SOPs will take effect on December 14, 2023. New SOPs: SOM SOP 201.1: Developing and...

The U.S. Food and Drug Administration (FDA) announced in August that it has finalized the guidance document titled “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors” to promote clarity on procedures and expectations for stakeholders carrying out informed consent in clinical investigations of FDA-regulated products. This guidance takes the...

On June 6, 2023, The U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance titled “E6(R3) Guideline for Good Clinical Practice.” This E6(R3) update aims to provide flexible, modern, and clear Good Clinical Practice (GCP) for conducting clinical research. The draft guidance is adopted from the...

The CRSO has created a bridge webpage to optimize access to clinical research-related policies and procedures housed in the SOM, UNC-Chapel Hill Electronic Policy Repository, and UNC Health PolicyStat. Explore the CRSO’s Policies and Procedures bride page to access and review UNC Chapel Hill and UNC Health clinical research-related policies...

Building on recommendations to facilitate decentralization of clinical trials during the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA or the Agency) issued the draft guidance titled, Decentralized Clinical Trials for Drugs, Biological Products, and Devices on May 2, 2023. A decentralized clinical trial (DCT) is a...

The U.S. Food and Drug Administration (FDA) published a final guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations, Questions and Answers, Guidance for Industry.” The guidance provides sponsors with information about implementing a risk-based approach to monitoring clinical studies of human drugs, biologics, medical devices, and combinations of these...

Collaboration is a key strength across the UNC School of Medicine for fostering connections and bolstering the translational research pipeline. Expand your research network with the Faculty Collaboration Database!

Self-assessment is a valuable activity that can improve the quality of clinical research operations and data. With the newest additions to the self-assessment toolbox, study teams can demonstrate due diligence in participant eligibility confirmation and study team qualifications and delegation documentation!

A competent and knowledgeable clinical research workforce is essential for the successful conduct of clinical research. Academic medical centers across the U.S. recognize this and are developing high-quality competency-based education and training materials for clinical research professionals. The DIAMOND portal brings these training materials to you!