Complion

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. 

Key Features

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

✅Ready to Start?

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

Additional Information

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  • Getting Started

    Use the link below to begin using Complion and or Study Binders

    Complion Account & Binder Request Form

     

  • 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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Support

Our Research Support Helpdesk is here to help: 

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

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