Investigator Initiated Trials Office

The Georgetown Lombardi Investigator Initiated Trials Office supports investigators throughout the Investigator Initiated Trials (IIT) lifecycle.

Services include:

  • Assistance with budget development
  • Protocol templates and medical writers for protocol development, reporting, and publication
  • Facilitation of biostatistical support for protocol development and reporting
  • Regulatory document submission, maintenance, reporting, and close-out, including submission to federal regulatory agencies and sponsors
  • Support for trial conduct including multi-site coordination
  • Quality control assessments and monitoring

The Georgetown Lombardi IIT Office is here to help you move your IIT from concept to clinical trial, and to assist you along the way with support for protocol development, regulatory submissions, and study management/monitoring through study close-out and reporting. Some of the support services we have available include:

  • Identifying funding sources
  • Protocol development/writing support
  • Regulatory start-up support including PRMC, FDA and IRB submission
  • IND application
  • Clinicaltrials.gov registration/reporting
  • We can help you interface with other important LCCC clinical trial support offices to help with:
  • Biostatistical support
  • Contract negotiations
  • Budget development/approval
  • Grant submissions/support

As a sponsor-investigator, you are responsible for the initiation and conduct of your IIT, with the dispensing and administration of the investigational drug under your immediate supervision. As sponsor-investigator, it is your duty to uphold all institutional, local and federal regulations. This includes, but is not limited to, ensuring data and safety monitoring of your study according to the Georgetown Lombardi Data Safety and Monitoring Plan, registering and reporting the results of your trial with Clinicaltrials.gov, ensuring the proper training of the sub-Investigators and study team, safety reporting to the FDA and GU IRB, oversight of study conduct, and investigational drug accountability. Please see these links for resources and training:

  • ORQA
  • DSMC
  • FDA

  • Please reach out to the project manager at your respective site (below) as soon as you have a concept, prior to beginning conversations with a funding source – if possible.
  • Submit your concept (or protocol if already developed) to the IIT Steering Committee (SC). All interventional/ treatment IITs are reviewed by the IIT SC, to assign IIT Office resources, prior to protocol review by PRMC. Please fill out the IIT SC submission documents (attach link) and email them to:

Quicklinks

Clinical Trials Office

IIT Templates

IIT Steering Committee Submission Documents