Florence

For active studies currently managed in Complion follow the steps below to migrate your binder and documents to Florence. Before following instruction below, ensure you have a designated Team Administrator.

Pre-Migration Setup

Step 1: Confirm Study Eligibility

Confirm study eligibility by ensuring the study meets all of the following:

1. Study is  active
2. Official study binder currently resides in Complion
3. Study is eligible to transition per institutional guidance 

Step 2: Create Study Inventory

Before exporting documents, develop a complete inventory of what exists in Complion. This inventory becomes authorative checklist for migration validation.

At a minimum we recommend the following:

• Study Title and IRB Number
• Binder sections currently used
• Document names and counts per section
• Current version numbers of approval status
• Total count of documents

The table below provides guidance on prioritizing content for migration.

*Department should consult sponsors or monitors if there is uncertainty about required content

Exporting Data from Complion

Step 3: Exporting Documents

Complion does not support a full-binder export, documents must be downloaded manually.

1. Log into Complion and opent the study binder
2. Navigate section-by-section through the binder
3. Download documents locally, ensuring:
   1. Original filenames are preserved
   2. Version history is retained where available
   3. Signature and approval pages are included

Important Notes

1. Workflow history and audit trails may not transfer
2. Secure storage must be used during download and staging

Step 4: Capture Supporting Metadata

For documents with regulatory relevance, capture key metadata during export:

• Approval and effective dates
• Version number
• Signatory (PI, sponsor, monitor, etc.)

Recommendation: Record metadata in the inventory spreadsheet or migration log.

Preparing Florence

Step 5: Verify Florence Study Setup

Before uploading any documents, confirm:

• The study shell exists in Florence
• The correct study type is selected (FDA vs. non-FDA)
• The binder structure follows institutional standards
• Required users have appropriate access

Avoid uploading documents until structure and permissions are confirmed.

Complion to Florence Section Mapping

The table below illustrates common section alignment. Exact structures may vary by study type.

Uploading into Florence

Step 6: Rebuild the Binder Structure

In Florence:

1. Create or confirm the appropriate section structure
2. Map Complion folders to Florence sections
3. Document any deviations or consolidations in the migration log

Step 7: Upload Documents

For each document:

• Upload to the correct Florence section
• Preserve the original filename on initial upload
• Complete Florence metadata fields when prompted
• Apply new approvals or signatures if required

Post Migration Validation (Required)

Step 8: Quality Control Review

After upload is complete:

• Compare the Complion inventory to Florence contents
• Validate document counts by section
• Spot-check critical documents (protocol, consent, delegation logs)
• Confirm documents are complete, current, and correctly filed

Step 9: Complete the Migration Log

• Study title and IRB number
• Date(s) of migration
• Name(s) of individual(s) performing migration
• Confirmation that required documents were migrated
• Notes on limitations or exceptions (if any)
• Final sign-off

This log should be retained with study documentation for audit readiness.

Known Limitations & Caveats

• Complion workflow history and certain audit elements may not transfer
• Metadata fields may not align one-to-one between systems
• Manual effort is required for each active study