Data Safety Monitoring Board (DSMB)

Overview

YCRG offers comprehensive Data Safety Monitoring Board (DSMB) services to ensure the ethical conduct of clinical trials and to protect the rights and safety of patients enrolled in the trial.

YCRG manages the organization and implementation of the DSMB and the organization and documentation of all committee meetings, and provides administrative support and communications support between the sponsor, clinical research organization, biostatistics and DSMB members.

All YCRG DSMB services are provided in conformance with regulatory requirements and can be initiated for single or multi-center, national or international clinical trials.

Role of the DSMB

The DSMB (also known as a Data Safety Monitoring Committee [DSMC] or Data Monitoring Committee [DMC]) is an independent panel of experts that periodically reviews clinical study data, incidental event reporting, and clinical study design.

The DSMB provides independent advice on the safety of human subjects, recommendations to assure that subjects are not exposed to undue risks, and an independent assessment of the ongoing scientific validity and merit of the study.

DSMB Composition

The DSMB is composed of a group of independent medical experts and biostatisticians with experience in the conduct of clinical trials and the therapeutic area of the study.

YCRG draws from a large group of medical and statistical experts with experience in the full spectrum of cardiovascular disease and treatment, the conduct of clinical trials and clinical study design, and contemporary clinical trial results. Medical and statistical expertise includes:

  • CAD,
  • Structural heart disease,
  • Peripheral vascular disease,
  • Oncology,
  • Neurology,
  • Electrophysiology,
  • Epidemiology and Outcomes Research,
  • Regulatory development and issues of concern, and
  • Trial experience in device, pharmacology, and biologics.

Committee Management

YCRG offers full DSMB management services, including:

  • Committee formation and appointment;
  • Ensuring balanced, experience committee composition;
  • Documenting relevant experience and absence of conflicts of interest; and
  • Recruiting members committed to the lifecycle of the project and with the flexibility to meet scheduling needs.
Complete DSMB documentation
  • Study-specific charter development;
  • Reporting format for Sponsor consistent with maintenance of independence and blinding;
  • Provision of reports for regulatory submissions; and
  • Full documentation of Committee discussions and decisions.
Data handling, management, and analysis
  • Including data transfer from clinical database to independent biostatisticians