Complion

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 $1250 per study e-binder.

To onboard with Complion:

1. Email resinfo@med.miami.edu to request study binders and include the following information:

  • For each study please provide the Investigator’s First and Last name, Department/Division, the eProst number (s), and Sponsor.
  • Please include the study team contact and finance administrator.
2. OVPRS finance will email an invoice to the study team contact and finance administrator with the total amount.
3. Interdepartmental payment is to be completed via Workday.
4. The invoice can be shared with sponsors or kept internally for record.
5. Once payment is complete, Research IT will facilitate system access and training directly with the study team contact.

Access to Complion

If you have a Complion account, you may access it by visiting https://complion.med.miami.edu.

For more information on the Complion system please contact: The Research Intelligence & Data Infrastructure support line 305-243-2314 or email resinfo@med.miami.edu.