“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, MDDirector, Regulatory Affairs
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:
- 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 new NIH requirements for multisite clinical trials
- Data and Safety Monitoring Board charter development, setup, meetings and consultations
- “Concept to approval” regulatory consultations regarding master contracts, 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 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.
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