FDA regulatory consultations are available to investigators interested in submitting a Pre-IND or IND application. If you would like to set up monitoring visits for your investigator-initiated studies or an FDA regulatory consultation, please contact us and submit a request. 

Clinical research monitoring is a key part of the clinical research process, ensuring the safety and accuracy of results. Our CCTR team can assist in the creation of the data and safety monitoring plan, and the development, implementation and closure of corrective and preventive actions (CAPA) through our monitoring services.  We are offering monitoring services in the following situations:

• The study is conducted by a Principal Investigator that is in the Department of Pediatrics; AND
• The study is investigator-initiated; AND
• The study is limited to a single site; AND
• Monitoring is required but not offered by the sponsor/institution.

Requests for monitoring must be submitted in advance of IRB approval of a monitoring plan to our Manager of Clinical Trials. CCTR must approve language to be included in submission and study documents. Requests will be considered on a first come first served basis. If CCTR is at capacity for monitoring services or is otherwise unable to monitor the study, the study team will be responsible for securing monitoring elsewhere.