The Elm

In an effort to assist Principal Investigators/Responsible Parties with remaining compliant with ClinicalTrials.gov requirements, UMB's Office of Accountability and Compliance (OAC) will begin sending automated correspondences to Responsible Parties identifying issues and errors with a registered record in ClinicalTrials.gov. 

The notices sent will provide you with the specific areas of concerns as it relates to your record and, as the Responsible Party for the record, you will be responsible for addressing any issues identified in the record. Problems that are noted in this new automated system will also include congruency issues between CICERO and the ClinicalTrials.gov record, in addition to problem record-related issues in ClinicalTrials.gov. 

If you have any questions or concerns or need assistance in getting your ClinicalTrials.gov record into compliance, please feel free to contact Edress Brunson, MS, research compliance specialist, at ebrunson@umaryland.edu or Sarah N. Archibald, PhD, MSL, MS, MDE, MA, CCEP, director, Auditing & Monitoring, at sarchibald@umaryland.edu.

OAC will be scheduling a ClinicalTrials.gov session later in the fall 2023 semester.

To request topics you would like to see covered in this session (or future sessions), please provide feedback at https://umaryland.az1.qualtrics.com/jfe/form/SV_8FYLgYatedY6jJA.