“Not sure if your multi-site project qualifies for a single IRB? Need a data and safety monitoring board, or a patient recruitment strategy? Request a consultation – we are here to help.”

Andreas Klein, MD
Director, Regulatory Affairs

Overview

Our Regulatory Support experts facilitate the improvement of clinical trials processes and the responsible conduct of human subjects research through interaction with local, state, and federal agencies and Tufts CTSI-affiliated institutions.

Areas of focus include:

  • Work with Harvard Catalyst on the Harvard Catalyst Common Reciprocal Reliance Agreement, allowing researchers to request that all institutions involved with a multi-institutional study rely on a single Institutional Review Board (IRB)
  • Data and Safety Monitoring Boards (DSMB) charter development, setup, meetings, and consultations
  • Consultations regarding master contracts, clinical trials processes, patient recruitment, Investigational New Drug (IND) applications, Investigational Device Exceptions (IDE), and certificates of confidentiality from the Food and Drug Administration (FDA).

Who is eligible?

Regulatory consultations are available to anyone.

DSMB services are offered for a fee to faculty members and trainees at academic, hospital, and community partner institutions. Costs are handled on a case-by-case basis and are determined by the complexity of the study, the funding source, and the investigator.

Contact

To contact us, please submit a service request. Please be sure to select General Consult and use the text box to describe your Regulatory question or request.

Andreas Klein, MD
Director, Regulatory Affairs

Tamsin Knox, MD
Associate Director, Regulatory Affairs