“Our Regulatory Support experts can help you optimize your clinical trial processes and ensure responsible conduct of your human subjects research project. We can help you navigate the complex regulatory landscape to collaborate effectively with local, state and federal authorities and Tufts CTSI-affiliated institutions.”

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 organizations.

Areas of focus include:

  • Assistance with institutional review board (IRB) submissions: protocol development, IRB form completion, consent forms, and communication with the IRB and Scientific Review Committee (SRC)
  • Working with single IRBs to comply with NIH requirements for multi-site clinical trials
  • Data and Safety Monitoring Board (DSMB) charter development, setup, meetings and consultations
  • Consultations regarding master contracts, FDA Investigational New Drug (IND) and Investigational Device Exemptions (IDE) filings, investigator training and responsibilities, clinical trials
    processes, and patient recruitment.

Who is eligible?

Regulatory consultations are available to investigators and staff affiliated with Tufts CTSI partners and collaborators.

DSMB services are offered for a fee to investigators and trainees at academic, hospital, and community partner organizations.

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.

For information on ClinicalTrials.gov, click here.

Andreas Klein, MD
Director, Regulatory Affairs

Tamsin Knox, MD
Associate Director, Regulatory Affairs

Kieran F. Reid, PhD, MPH
Research Participant Advocate