CMS now requires documentation of the appropriateness of qualified clinical trials for patients receiving Medicaid benefits. The attestation form will require signature of the Principal Investigator, and in some cases, a...

The Federal Government is rolling out a centralized portal, login.gov, to provide secure access to all government agencies through a single username/password with two-factor authentication. NIH reviewers were required in...

From Jonathan Crabtree, Director — UNC Research Data Management Core We have been made aware that the information regarding data management and sharing plan (DMSP) audits and review on the rdmc.unc.edu website was...

Dear SOM Clinical Research Community, Please see the below information disseminated today from Carolina Leadership: While the University is not requiring the COVID-19 vaccine for students, faculty or staff, it is...

From the March 24, 2023 post at nexus.od.nih.gov by Dr. Michael Lauer—NIH's Deputy Director for Extramural Research. As the largest public funder of clinical trials in the United States, NIH is committed to the...

From Andrew Thorne, PharmD, MS System Clinical Manager Investigational Drug Services UNC Health Logistical considerations for medication management of future clinical trials with patient encounters at Eastowne Medical Office...

As January 25, 2023—the effective date of the new NIH Data Management and Sharing (DMS) Policy—approaches, the NIH continues to develop resources and implementation information to help the community prepare. (see:...

Andy Johns, Senior Associate Vice Chancellor for Research, has issued a notice regarding requirement for approval for clinical research support systems. The notice requires that any unit which proposes to purchase or implement...

As of October 1, 2021, NIH has implemented new eRA RPPR submission system validations for clinical trial registration and results reporting. RPPRs that have associated clinical trials that are non-compliant with these requirements...

If you have a study registered at ClinicalTrials.gov that meets the Applicable Clinical Trial (ACT) definition and/or an NIH-funded "Clinical Trial," please be aware that results reporting is required by federal law. The...