Services
The Office for Clinical Research offers many services to support clinical research at Emory University and Emory Healthcare. OCR has six distinct functional teams and to learn more about the responsibilities of each team, click the team's name below.
The Georgia CTSA Navigator Team facilitates the flow of clinical research trials from concept to initial approval and implementation by assisting with maintaining compliance, quality, and innovation activities for each of the research offices at the Georgia CTSA's partner institutions.
Meet the Clinical Research Navigators
Services Provided
Investigator Dashboard provides a window into the approval process, allowing study teams to view the progress of studies pending approval.
Liaison to the Trial Innovation Network (TIN) allows study investigators of multi-site trials to request an initial consultation or specific trial resources.
Data Safety and Monitoring Board Services offers studio consultations and resources to support the investigator in developing a Data Safety Monitoring Plan and/or Board.
View Services for Investigators
The Rapid Response Team
Streamlines and facilitates the pre-award approval process for high-priority NIH and/or other federally funded network studies that need fast-track approvals.
Contact Us
Send an email to My Research Navigator
Visit the Georgia Clinical Translation and Science Alliance
This work is supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award number UL1TR002378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health." KL2 Scholars should also list KL2TR002381, and TL1 Trainees should also list TL1TR002382.
Coverage Analysis
Aligns the CA and budget to ensure study-related items and services are assigned to the appropriate third-party payor according to CMS regulations. Currently, CAs are outsourced.
Budget Development Services
Develops and negotiates financially viable study budgets to cover all costs identified in the protocol, informed consent document (ICD), clinical trials agreement (CTA), and sponsor's budget. OCR will outline and notify the PI, Office of Sponsored Programs (OSP), and the Department of Finance of a deficit via a formal deficit letter.
Letters of Intent for industry and non-federal studies
Develops a prospective budget that the PI can use to reach out to industry sponsors for funding.
Clinical Research Education and Outreach
Provides clinical research orientation for new hires, rehires, and promotions to assign a learning track based on experience and years at Emory, including fast-tracked Emory Healthcare Credentialing for staff that meets specific tier criteria.
Provides mandatory courses via a classroom environment or online modules for clinical research investigators, coordinators, residents, and fellows functioning in the coordinator role and investigators via the training policy.
Develops and coordinates training for investigators and coordinators through Emory's Learning Management System.
Provides individualized and group training for conducting clinical research at Emory, research billing compliance, and OnCore Clinical Trials Management System (CTMS).
Provides a bridge course to understand system and process workflow between OnCore CTMS and Emory Healthcare's Epic medical record system.
Offers Basic Life Support training through the American Heart Association for Emory University staff when it is required for their credentialing.
Educational Seminars
Designs and hosts the "Research Matters" lecture series and informational forum at Emory and Grady, offering continuing education credits.
Improves communication, outreach, and relevance with faculty, fellows, residents, and coordinators through specialized sessions, either 1:1 or at departmental meetings.
Customer Service and Quality Improvement
Manages the content of the OCR website as a resource for the research community.
Maintains a training record system for all Emory and Emory affiliates of training and Emory Healthcare Credentialing.
Publish the monthly report of active clinical trials & research participants to the OCR website.
Triages and follows up on issues from OCR's mailbox and "help desk" calls from the central OCR phone line.
Investigator Consultations and Handbook
Investigator consultations are to assist new, incoming, or exiting investigators in clinical research with the process and workflow. Investigators can schedule a consultation via MS Bookings with Dr. John Doan, senior research Services Consultant. View details here.
The Investigator Handbook is currently under construction. It is designed to disseminate information for investigators and clinical research staff and provide guidance on the initiation and completion of a grant's life cycle, including funding, proposal development, grant award, award closeout, record retention, subject recruitment, and preparing for an audit.
Data Entry, Tracking & Reporting Services
Activates studies in OnCore CTMS upon receipt of award notice and IRB approval.
Pushes research study, participant data, and informed consent documents into Epic to enhance patient safety and create an authoritative list of Emory's active clinical trials and research participants. This initiates the bill hold process in the Epic medical record system.
Updates study statuses in OnCore CTMS as needed.
Invoicing & Reporting Services
Generates invoices to industry sponsors for start-up costs, visit level, pass-through, and milestones items.Receives payments directly from industry sponsors for invoiceable and/or non-invoiceable items and services.
Processes patient stipends and travel reimbursements.
Processes payments to external vendors, e.g., GHS, WIRB, and RECIST.
Generates and distributes monthly reports to investigators, departments, and RAS at OnCore CTMS.
What does OCR Invoicing manage?
Identify Studies Needing Coverage Analysis (CA), OnCore CTMS & ClinicalTrials.gov Entry
Assists faculty and staff with reviewing protocols to ensure compliance with research billing and clinical trials. Serves as a liaison and facilitates adherence to clinical research requirements, as well as the following, but not limited to:
- Assistance with clinical trial determinations per the NIH, FDA, and International Committee of Journal Editors (ICMJE) definitions
- Reviewing study protocols to ensure all federal and institutional requirements are met
- Ensuring obligations for ClinicalTrials.gov for investigator-initiated studies
- Providing information and guidance regarding ClinicalTrials.gov requirements
- Managing studies with the Emory ClinicalTrials.gov Service Center
- Fostering relationships to improve communication and processes relating to investigator-initiated, Emory-sponsored clinical research
ClinicalTrials.gov Registration, Updates, & Results Reporting
Disseminates clinical trial information for investigator-initiated, Emory-sponsored studies and ensures registration, timely updates, and results reporting requirements are met per federal regulations and policies.
Track ClinicalTrials.gov Identifiers (NCT#s) for Medicare Reimbursements
Assists with tracking and ensuring availability of NCT numbers for CMS reimbursement for claims.