Clinical Research Contracting (CRC)

Mont Brownlee - Executive Director, Clinical Research Contracting 

The CRC team is dedicated to supporting the Johns Hopkins University School of Medicine’s research mission by offering sponsored research expertise, ensuring compliance with applicable regulations and institutional policies, and providing excellent service to clinical research investigators and staff to advance biomedical research and discovery. 

The CRC handles all clinical research agreements with commercial entities. Clinical research is considered research that involves patients, Protected Health Information (PHI), clinical testing or procedures, drug or device trials, and planning of clinical/lab services in support of clinical research.

Clinical research agreements with commercial entities require signatures from both the sponsor and a university institutional official (IO) with signature authority. Within the CRC, designated team members serve as IOs for the commercially sponsored agreements and have the authority to commit the institution to the agreement's terms and conditions. Principal Investigator, clinical research staff, hospital personnel, and others cannot sign these agreements on behalf of the University. However, the Principal Investigator usually signs the agreement in acknowledgment that the contract has been read and understood. 

Questions related to CDA/NDA? Email [email protected]

Questions related to commercial research contracts? Email [email protected]

CRC Department Assignments

Clinical Research Support Services (CRSS) and Clinical Research Billing Compliance (CRBC)

Karen Roz - Senior Director, Clinical Research Support Service and Clinical Research Billing Compliance

Clinical Research Support Services (CRSS) develops the prospective reimbursement analysis (PRA) for clinical research that can generate a patient care charge. CRSS also provides support and education to clinical research teams regarding budget development and budget negotiation with commercial sponsors. The CRSS team develops and negotiates clinical trial budgets upon request.

Clinical Research Billing Compliance (CRBC) ensures timely, compliant billing practices for research services related to clinical research participation. CRBC uses the prospective reimbursement analysis as a basis for billing adjudication. This “adjudication process” is carried out for hospital inpatient/outpatient and professional fee charges. The CRBC is also responsible for regulatory monitoring related to clinical research billing.

Questions? Please email your inquiry to [email protected]; [email protected]

For more information visit:

• Clinical Research Revenue Cycle (hopkinsmedicine.org)
• Resources (hopkinsmedicine.org)
• School of Medicine Office of Research & Administration Contact Info

IND/IDE Regulatory Program

The Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program provides guidance to clinical investigators, sponsors, and sponsor-investigators regarding the process to secure institutional approval to serve in the role of sponsor-investigator and submit an application for an IND or IDE to the FDA (Food and Drug Administration) in accordance with the institutional policy on Investigator-held INDs/IDEs.

For questions: [email protected]

Clinical Research Revenue Cycle (CRRC)

Scott Streibich - Director, Clinical Research Revenue Cycle 

The CRRC is responsible for implementing and expanding Clinical Research Revenue Cycle systems and workflows, promoting clinical trial revenue cycle reporting infrastructure, and providing related support to clinical investigators and their research teams. CRRC works to implement processes and guidance for clinical trial billing and reporting, coordinates delivery and development of related educational material, and collaborates with clinical research support personnel across the School of Medicine and Johns Hopkins Medicine (JHM) to tie together operational workflows, planning, policy development, financial management systems, and reporting on clinical research revenue cycle activities. The CRRC serves as an expert internal resource for clinical research investigators, clinical research staff, and administrators.

Questions? Email Scott at [email protected]