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 partner institutions of the Georgia CTSA.

Meet the Clinical Research Navigators

View Quick Reference Guide (PDF)

Services Provided

Investigator Dashboard provides a window into the approval process allowing study teams the capability of viewing real-time progress of studies pending approval.

Liaison to the Trial Innovation Network (TIN) offers study investigators of multi-site trials the ability to request an initial consultation or specific resources for trials.

View TIN

Data Safety and Monitoring Board Services offers studio consultations and resources that support the investigator with the development of Data Safety Monitoring Plan and/or Board.

View Services for Investigators

Rapid Response Team streamlines and facilitates the pre-award approval process for high priority NIH and/or other federally funded network studies needing fast-track approvals.

Meet the Rapid Response Team 

Investigator Handbook

The Investigator Handbook is currently under construction. The handbook is designed to disseminate information for investigators and the clinical research staff with guidance on the initiation and completion of a grant life cycle including funding, proposal development, grant award, award closeout, record retention, subject recruitment and preparing for an audit.

Contact Us

Send email to My Research Navigator

Visit the Georgia Clinical Translation and Science Alliance

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.

Prospective Reimbursement Analysis

Performs prospective reimbursement analysis (PRA) to clearly identify which study-related items & services can be billed to third party payor according to the CMS regulations.

Budget Development Services

Develops and negotiates financially viable study budgets to cover all cost identified in the protocol, informed consent document (ICD), clinical trials agreement (CTA) & sponsor's budget. OCR will outline and notify the PI, Office of Sponsored Programs (OSP) & Office of Business & Finance (OBF) of a deficit via a formal deficit letter, if needed.

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.

Education and Quality Improvement Services

Clinical Research Education

Provides mandatory courses via a classroom environment or online modules for clinical research coordinators, residents, and fellows functioning in the coordinator role and investigators.

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 Emory Research Management System (ERMS).

Offers Basic Life Support training through the American Heart Association for Emory University staff when it is required for their credentialing.

Educational Seminars

Designs & 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.

Triages and follows-up on issues from OCR's mailbox and "help desk" calls from the central OCR phone line.

Data Entry, Tracking & Reporting Services

This team 

  • Activates studies in ERMS upon receipt of notice of award along with IRB approval.
  • Enters study level documents into PowerTrials, e.g. PRAs, IDS Drug Data Sheets & Clinical Research Key Points including special form for studies deemed "sensitive" by the IRB.
  • Enters research participant data and informed consent documents into the clinical trials tab within PowerTrials to enhance patient safety and to create an authoritative list of active clinical trials & active research participants at Emory. This flag initiates the bill hold process in HealthQuest & IDX.
  • Publish the monthly report of active clinical trials & research participants to the OCR website.

This team: 
  • 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.

What does OCR Invoicing manage?

View Attributes for OCR Invoicing Study Management (DOCX)

Identify Studies Needing PRA, ERMS, & Entry

Provides assistance to faculty and staff with reviewing protocols to ensure research billing and clinical trials compliance. 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 for investigator-initiated studies
  • Providing information and guidance regarding requirements
  • Managing studies with the Emory Service Center
  • Fostering relationships to improve communication and processes relating to investigator-initiated, Emory-sponsored clinical research 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 Identifiers (NCT#s) for Medicare Reimbursements

Assists with tracking and ensuring availability of NCT numbers for the purpose of CMS reimbursement for claims.