Complion

The Complion^TM 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.

Key Features

Secure Document Storage & Compliance Tracking
Robust Audit Trails & Role Based Access
Collaboration & Workflow Integration

System Access

You must submit an account request form in order to access and use Complion. Please see the Getting Started section below to submit a request.

If you already have an account, log in using the button below:

System Login

Getting Started

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Complion Account Request
Complion Binder Request
Resources

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.

Regulatory Binders Policy

If your research does not fall under this policy provided above, you may still use Complion. 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.

FAQ

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What is Complion used for at the University of Miami?

Complion is the University’s eRegulatory binder system, used to manage electronic study binders for clinical trials and FDA-regulated research.
How do I request an eBinder in Complion?

You can request an eBinder through the Research Intelligence & Capacity (RIC) support form.

Support Forms
What is the document retention policy in Complion?

The standard retention policy is 10 years. This is important for responding to sponsor questionnaires and audits.
Why am I being prompted to open a study binder in Complion?

This typically occurs when your study has been flagged as requiring regulatory documentation management. It may be tied to IRB approvals or sponsor requirements.
How do I ensure Part 11 compliance when using Complion?

Complion is already a Part 11 compliant system. However, if you’re using other tools (like Adobe Sign), you must follow specific validated processes to maintain compliance.

Support

Our Research Support Helpdesk is here to help:

Monday - Friday
8:00 AM - 5:00 PM
305-243-2314

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Complion

Key Features

System Access

Getting Started

FAQ

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