Site Qualifications

The Department of Genetics and Genomic Sciences understands that site selection has the potential to make or break a clinical trial. That is why we have a Clinical Trials Office dedicated to making sure each study’s unique needs are met. This includes identifying and selecting the best personnel for a successful clinical trial. With the help from our resources at ISMMS, we will help simplify the clinical trials qualification and training process.      

Principal Investigators

Our Principal Investigators (PIs) are expert clinicians and experienced researchers. We are dedicated to providing oversight to ongoing research. The rights, safety, and overall well-being of study participants is paramount.

A qualified physician is responsible for the medical decisions made on behalf of study participants. Our highly integrated clinical and research teams aid in study recruitment. We are early and high recruiters for clinical trials. Additional information about our Principal Investigators, including curriculum vitae, are available upon request.

Study Staff

We strategically staff our studies with multiple experienced clinical research coordinators to ensure each study’s objectives are met.  We are experienced in tracking and reporting adverse events; adverse events of clinical interest; serious adverse events; and protocol deviations. With extensive experience in source document development, completing case report forms, and multiple electronic data capture systems, our staff is prepared for the unexpected.

Our study team members are required to comply with local, state, federal, and international regulations and guidelines. The following certificates are available upon request and are provided when our site is selected for a study:

  • Collaborative Institutional Training Initiative (CITI)
    • Good clinical practice
    • Human subjects’ research
    • Data security
    • Health Insurance Portability and Accountability Act (HIPAA)
    • International Air Transport Association (IATA)

Confidential Disclosure Agreements

Before receiving study documents from sponsors, investigators should sign a confidential disclosure agreement (CDA). Principal Investigators do not have the authority to sign or execute CDAs. Confidential disclosure agreements are executed by the Financial Administration of Clinical Trials Services (FACTS) office.  

Hetanshi Naik, PhD, Director of Clinical Research within the Department  facilitates the execution of all CDAs through the FACTS office. Once the CDA is executed, it will be provided to the sponsor. Once study documents are received from the sponsor they will be reviewed in a timely manner for feasibility.

Clinical Trial Agreements

Clinical Trial Agreements (CTA) are executed by the FACTS office. Clinical trial agreements typically take two months to process. This process is completed concurrently with initial Institutional Review Board (IRB) review and budget negotiation. Initial CTAs should be sent to Dr. Naik who will facilitate the execution with the FACTS office.

Financial Services

The CTO provides the following financial services from the start of the study to closeout:

  • Budget development and budget negotiation
  • Facilitation of financial conflict of interest review with the Conflict of Interest (COI) Office
  • Facilitation with our Grants and Contracts Office (GCO)
  • Timely invoicing and account reconciliation

Institutional Review Board

Our office uses a local institutional review board (IRB) for regulatory review.

External IRB review is available upon request and approval. The average turnaround time for full board projects is eight weeks from submission. Expedited approval is available for minor changes. The average turnaround time for expedited projects is six weeks from submission.

Initial and annual IRB reviews are completed concurrently with the financial COI Office review and GCO office review. Studies using medications must be reviewed by the Investigational Drug Service concurrently with IRB review. Any study involving X-rays, scan, or radiation therapy must be reviewed by the Radiation Safety Committee concurrently with IRB review. If a study involves recombinant DNA or genetically modified material, the study must be reviewed by the institutional biosafety program concurrently with IRB review.  

Visit the Program for the Protection of Human Subjects for additional information on the IRB. 

Investigational Drug Service

The Investigational Drug Service is a full-service research pharmacy. Its services include:

  • Secure, temperature-monitored, investigational product storage
  • Drug accountability and supply chain management
  • Investigational product preparation
  • Investigational product disposal

Clinical Research Unit

The Clinical Research Unit (CRU) is a clinic dedicated to conducting outpatient clinical research. The CRU is staffed by nurse practitioners, research nurses, and medical assistants trained in clinical research and adverse event monitoring.

Emergency equipment, such as crash carts, anaphylaxis kits, and oxygen, is available in the event of medical emergencies. The CRU’s most requested procedures include vital signs, physical exams, electrocardiograms (EKG), specimen sampling and processing, study drug administration, and pharmacokinetics. The clinical research unit has a laboratory for processing and storing study specimens with a refrigerated centrifuge, refrigerator, -20 C freezer, and -80 C freezer. Dry ice is available. All of the equipment is backed up by generators.

The CRU staff is experienced with pediatric phlebotomy, and walk-in phlebotomy services are available. If an overnight visit is required, the inpatient stay will take place in a different area of the hospital.  

Other Information

We store subject binders, regulatory binders, and study equipment in secured cabinets only accessible to authorized individuals. Our study records are stored on site for five years post-study closure. After five years, our records are then archived for a period specified in the CTA. Only study personnel have the information required to retrieve study records from the archives. Our clinical laboratory also offers routine and stat lab testing.

Mount Sinai uses the Epic electronic medical records system. Epic is Part 11 compliant. A letter of attestation is available on request. Our site has undergone FDA audits in the past and has never been cited for any issues.