Automated Regulatory Compliance
The Computational Medicine Center has developed several modules that automate the submission of protocols for compliance committee review. Funded by a National Institutes of Health (NIH)grant, this system began implementation throughout Cincinnati Children's Hospital Medical Center in 2004.
Highlights of the system include:
- A wizard that generates a list of required forms and tasks to be completed for protocol submission
- A wizard for generating informed consent forms
- A module for tracking required investigator training and administering online courses
A future version of this system will integrate with our protocol management system, enabling users to create online study binders. The approved protocol, committee approvals, consent forms, case report forms and adverse event reports will be stored electronically, eliminating paper binders and facilitating automated compliance auditing.
Guiding system development is a matrix of current regulations including FDA Good Clinical Practice regulations, the ICH Good Clinical Practice Consolidated Guideline, Investigational New Drug (IND) applications and NIST 800-26 self-assessment regulations that indicate which regulation can be automated based on a task-analysis model.
