Investigator Support Program
Investigator-Initiated Clinical Trials (IIT) are pivotal to advancing science and health care. The Investigator Support Program is dedicated to supporting the complexities of single and multi-site IITs including investigator training, FDA submissions, regulatory submissions, document management, monitoring, project management and mult-site management.
The program also serves as an academic research organization that oversees the management and execution of multicenter clinical trials.
Request a consultation for SISP Services: investigatorsupport@kumc.edu
- Protocol and supplemental document review during study development
- Assisting in preparation and initial IND/IDE submission to FDA
- Managing follow-on submissions to FDA
- Safety monitoring plan review/development
- Safety monitoring of eligible trials
- Good Clinical Practice guidance and resource navigation
Monitoring Services
Investigator Support Program provides monitoring services for single- and multi-site IITs. Fee-based monitoring by Investigator Support is required for IITs conducted under an IND or IDE.ISP monitoring services include the development of the Clinical Trail Monitoring Plan and monitoring conduct
Regulatory Support and Document Management
IND/IDE Support
Our experienced staff provided required assistance to Sponsor-Investigators and their study teams in preparing, submitting, and maintaining applications to the Food and Drug Administration (FDA) in the conduct of FDA-regulated clinical trials.
Additional support includes:
- Clinicaltrials.gov management
- IRB Reliance Submissions for multi-site IITs managed by ISP
- Regulatory training and consultations
- Essential document centralization
- Essential document management (study and site files)
Participating Site Management
The Investigator Support Program offers academic research organization coordination for multicenter clinical trials. The Project Management team coordinates activities between the principal investigator, research teams, study sites, and sponsors, with experience supporting clinical trials funded by industry, foundation and government agencies.
- Provide infrastructure that supports the planning, activation, and management of multicenter clinical trials.
- Support regulatory complexities, including management of trial master files, IND/IDE submissions to FDA and administrative support for Data Safety Monitoring Boards
- Oversee site onboarding, training, and communication
- Coordinate monitoring and regulatory support
Data Safety Monitoring Board Support (DSMB)
Administrative support for IIT Data Safety Monitoring Boards (DSMB) includes:
- DSMB charter development assistance
- Management of DSMB activities, including scheduling, conducting and documentation of DSMB meetings
- Training and onboarding of DSMB members