Overview
The ComplionTM system is the University of Miami’s 21-CFR-11 compliant electronic regulatory binder system. The system establishes standard processes and procedures for accessing a study, which is structured and organized to reflect all essential documents following best practices. The system allows the monitor/Sponsor the capability to obtain an electronic copy or print the documents, by being granted access to the identified trial(s)’ regulatory documentation within Complion. Remote access of regulatory documentation by sponsors may support expedited startup, increase communication, enable remote monitoring, and provide highly secure, cost-effective, long-term archiving. Electronic signature capability is also offered as part of the product.
Complion was first implemented at the Sylvester Comprehensive Cancer Center in 2018. In June 2021, the Use of Electronic Regulatory Binders in FDA-Regulated Research policy went into effect inviting the rest of the University research enterprise to onboard with Complion. Please see next section on how the Complion Onboarding process.
Complion Onboarding Process
It is important that you read the Use of Electronic Regulatory Binders in FDA-Regulated Research to understand if you are required to use Complion. If your research does not fall under this policy, you may still use Complion to reap the benefits of moving from a paper-based process to electronic. There is a one-time fee of $1,062.50 per study e-binder. This fee is only applicable to externally funded studies. Intramurally funded (i.e., non-sponsored studies) Investigator Initiated Trials e-binders can be requested at no cost.
To request a Complion electronic binder you must complete the New Complion Binder Form below. Please note, a Workday Account must be provided in the form.
Access to Complion
If you have a Complion account, you may access it by visiting https://complion.med.miami.edu. If you require access, please email the OVPRS Help Desk and a form will be emailed you to complete.
For more information on the Complion system please contact: The Research IT at 305-243-2314 or email the OVPRS Help Desk.
