Policies & Regulations

NIH Clinical Trials Reporting Compliance: A Shared Commitment

17 April 2023

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...

Clinical trials medication management at Eastowne Medical

15 March 2021

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...

Resources available for new NIH Data Management and Sharing Policy effective Jan 2023

09 January 2023

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:...

Requirements for electronic system or solution purchase

05 March 2021

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...

New eRA RPPR submission system validations for clinical trial registration and results reporting

03 December 2021

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...

Reporting requirements for studies listed at ClinicalTrials.gov

05 October 2020

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...

NIH "login.gov" account signup required by Sep 15 to use services

22 March 2021

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...

NIH Loan Repayment Programs 2020

14 September 2020

Release Date: September 14, 2020 The National Institutes of Health (NIH) is accepting new and renewal applications for its five (5) Loan Repayment Programs that provide support...

COVID-19 vaccine self-reporting at UNC

18 March 2021

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...

FDA releases guidance regarding civil money penalties

18 August 2020

The Food and Drug Administration (FDA) has issued the final guidance titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” This guidance describes the authority of the FDA to assess civil money penalties...