A sponsor or contract research organization (CRO) identifies UCI as a potential site for a clinical trial.
The sponsor and principal investigator (PI) connect to discuss ideas for collaboration or project.
A confidential disclosure agreement (CDA) is sent to the PI or CCR administrator prior to receiving the clinical trial protocol to protect confidential information.
The CDA must be reviewed, negotiated and executed by the Sponsored Projects Administration (SPA).
At the sponsor’s request, a pre-selection site visit (PSSV) or site qualification visit (SQV) may be scheduled.
Once participation in the industry-sponsored clinical trial appears likely, the proposal/scope of work (SOW) needs to be prepared and submitted to Sponsored Projects in Kuali Research (KR).
The PI and study team proceed with other required startup activities, including developing and negotiating the budget and coverage analysis (CA) working with CCR Administration.
An IRB application needs to be submitted to Human Research Protections, as well as other review committees as applicable (e.g. PRMC, CRB, RDRC, hSCRO, IBC, COIOC).
Once CTA and budget negotiations are complete and IRB has approved the study, study activation begins, which includes the site initiation visit.
Subject recruitment and enrollment begin.
Note, study activities and subject management needs to be tracked in OnCore CTMS.