Services
Emory Clinical Research Office offers many services to support clinical research at Emory University and Emory Healthcare. ECRO has five distinct functional teams and to learn more about the responsibilities of each team, click the team's name below.
Clinical Research Orientation and Training (CRO and CRT)
Provides mandatory clinical research orientation for new hires, rehires, and promotions, assigning a learning track based on experience and years at Emory, including fast-tracked Emory Healthcare Credentialing for staff who meet specific tier criteria.
Provides mandatory courses through classroom instruction or online modules for clinical research investigators, coordinators, residents, and fellows in coordinator roles, as well as investigators, per the guidelines.
Customer Services and Quality Improvement
Manages the ECRO website content as a resource for the research community.
Improves communication, outreach, and relevance with faculty, fellows, residents, and coordinators through specialized sessions, either 1:1 or at departmental meetings.
Maintains a training record system for all Emory and Emory affiliates of training and Emory Healthcare Credentialing.
Triages and follows up on issues from ECRO's mailbox and "help desk" calls from the central ECRO phone line.
Educational Seminars
Designs and hosts the "Research Matters" educational seminar lecture series and informational forum at Emory and Grady, offering continuing education credits.
Investigator Consultations
Investigator consultations help new, incoming, or exiting investigators with the clinical research process and workflow. Investigators can schedule a consultation with Dr. John Doan, Senior Research Services Consultant, via MS Bookings. View details here.
General Consultations
General consultations help new, incoming, or exiting staff navigate the clinical research process and workflow. Staff can schedule a consultation with any member of the ECRO CRSS via MS Bookings.
System Approval Access
Provides individualized and group access to digital systems for clinical research after verifying training in the Emory OnCore Clinical Trials Management System (CTMS) and/or Epic Medical Records System.
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. ECRO 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.
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.