Budget preparation and grant writing services are available to investigators. Budgeting has been added as a core competency of clinical trial coordinators in the OCR. The OCR has also been empowered to exclusively control clinical trials contracting for OCR/PCI studies, including hiring a dedicated contracts/budgets specialist who can negotiate and execute contracts and coordinate legal review with external sponsors.
Clinical Trials Management System
A web-based Clinical Trials Management System (CTMS) (MergeR) has been adopted that provides the following integrative package: A database of contacts and study descriptors, data integrity and patient safety, budgetary and financial tracking, electronic document development and storage, document and event tracking, schedule and activity tracking, reporting to outside agencies/sponsors, invoicing capabilities, and integration with EHRs of hospital systems affiliated with UTHSC. A detailed appointment and telephone follow-up system is in use by study coordinators for all study subjects and to coordinate subjects' schedules with doctors' and technicians' schedules. The CTMS system is also used for review and reporting of demographics of subject recruitment and visits, and metrics of efficiency.
The PCI offers outpatient and inpatient clinical trials space in multiple convenient locations. Availability is determined through a managed calendar using a “block” system. A clear and formalized application system for space has been implemented, subject to clear rules for evaluation and reconsideration. The CFRI Pediatric Clinical Research Unit at Le Bonheur Children’s Hospital is used for pediatric studies.
Invoicing and payments
Using the CTMS, all accounts payable and receivable payments are now processed through the OCR. Invoicing and payment matching in the CTMS allows regular invoicing to study sponsors to be directly matched with study costs (vendor invoices and personnel time) in real time.
Identification of Research Funding Opportunities
Investigators are provided assistance with identifying non-iRISE funding sources, including other NIH, federal and industry grants and contracts. When appropriate, investigators will also be directed to funding opportunities available through the iRISE PTCS Program and iRISE Career Development Grant Program.
The OCR/PCI works closely with iRISE mSHARE and community engagement resources to assist with the conduct of community-based research. The OCR/PCI module, in concert with other iRISE modules, will organize, implement and track studies conducted in these venues, including all financial arrangements.