Introduction to Research Credentialing

Research Credentialing (RC) reviews new clinical trials and modifications to existing clinical trials, under the pre-review process in eResearch.

RC becomes aware of new clinical research, or modifications/continuing review applications, when a study is routed in the eResearch database for Ancillary Review.

New Clinical Research and Clinical Research Modifications

The RC team reviews research applications to ensure Hackensack Meridian Health (HMH)-required information, investigator credentialing documents and CITI training are in place for each protocol, prior to IRB review.

The RC review consists of the following: The eResearch application, protocol, Investigator/Research Team Credentials and HMH-required training.

Ensure that updated CVs and Intellectual Property Agreements (if applicable), are uploaded into the eResearch system for all Investigators. CV’s are required to be signed and dated every 2 years. Researchers may use a wet ink signature or DocuSign.

All required documents should be uploaded into eResearch (Profile > Documents > Update Profile > +Add)

1 & 2 eResearch Application and Protocol

Information in both the protocol and eResearch application are reviewed. These documents are cross-checked to ensure inconsistencies are brought to the attention of the Principal Investigator for resolution. 

Recommendations are made to seek the Ancillary review and approval of the PI’s Chair, each Department Chair where the research will occur, as well as, the Chairs of School of Medicine, Center for Discovery and Innovation (CDI), Grants, pediatrics, and others, as applicable.

3. Investigators & the Research Team

The eResearch application is reviewed to ensure investigators, students, consultants, and/or research team members listed in the protocol are not debarred or excluded from conducting clinical research, and are appropriately identified and/or credentialed. RC adheres to HMH’s SOP, Eligibility to Conduct Research at HMH for guidance on researcher eligibility.

• Eligibility to Conduct Research at HMH
• Intellectual Property Policy
• Intellectual Property Agreement
• FDA Debarrment List

5. CITI TRAINING

Each research team member is required to complete training in human subject protection provided by CITI, and update training periodically. It typically includes the following courses:

• Good Clinical Practice
• Biomedical or Social Behavioral Researcher
• Information Privacy and Security
• Biomedical or Social Behavioral Responsible Conduct of Research

HMH CITI Training Guidance
CITI Training Website

6. Export Control

Research Credentialing will contact the HMH Corporate Compliance -Research Division, when International Students, Research Scholars, Visitors, and Volunteers are identified in clinical research.

Export Controls Management and Compliance policy
Research Scholars, Visitors, and Volunteers

The Research Credentialing Team