Mission of the Investigator Sponsored Research Unit Program
The mission of the program is to facilitate the development of investigator-initiated prospective trials in any aspect of cancer treatment or prevention. Particular emphasis is given to trials that emerge from laboratory, clinical or epidemiologic studies conducted at Fox Chase and affiliated institutions.
Who is a Sponsor-Investigator?
A sponsor-investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term, as defined in FDA regulations, does not include any entity other than an individual. As the name suggests, a sponsor-investigator assumes the responsibilities of, and must comply with, FDA regulations applicable to both a sponsor and an investigator.
Responsibilities of the ISRU
- Assist the investigators from initial protocol development to study activation.
- For studies that will have subject enrollment at sites other than Fox Chase Cancer Center, the ISRU may conduct new site evaluation visits to evaluate and assist in setting appropriate infrastructure and maintain a site scoring system to facilitate the identification of appropriate sites to conduct clinical trials based on capability, disease sites, compliance, accrual and data accuracy.
- Monitor research as appropriate including, but not limited to, patient case records, regulatory documentation, lab and pharmacy operations.
- Verify investigators and research staff have completed appropriate training as dictated by local site, Federal, State, Local and Institutional guidelines.
What we actually do
ISRU assistance can be provided- if any of the following apply (when in doubt, please reach out for assistance):
- Assisting in Clinical Protocol Development (Template is provided by the Protocol Development Team).
- Development of case report forms, databases for the trial etc.
- DSMB oversight to studies (as needed).
- Providing assistance with registering studies on CT.gov.
- Providing assistance with presentation of abstracts, posters and manuscripts.
What we don’t do
ISRU is not involved in:
- Writing the actual Clinical Research Protocol. The Protocol Development Team at ISRU only assists with Protocol Development.
- ISRU does not assist with retrospective studies, data set creation from existing data or registry studies.
Study Development Assistance from ISRU:
- Any investigator preparing an investigator initiated sponsored clinical trial should contact ISRU at email@example.com as part of the initial planning steps.
- ISRU will ensure that any affiliated site, investigator, and research staff participating in an investigator-sponsored study, conducts the appropriate steps to ensure that all regulatory and contractual obligations have been met prior to screening and enrolling patients at their site and that they have received education in the roles and responsibilities of conducting clinical trials, protocol specific procedures, adverse event reporting, drug procurement and handling, case report form completion and submission processes, and to identify any possible concerns.