Frequently asked questions

Florence is the electronic Investigator Site File (eISF) platform used at Barts Health to manage essential study documentation electronically. It provides controlled access, document version management, audit trails and electronic signatures, and supports remote monitoring, oversight, audit and inspection activities. 

Using Florence provides a consistent approach to managing electronic study records across Barts Health and reduces reliance on paper-based Investigator Site Files. 

Barts Health has undertaken local validation and readiness activities for Florence, including assessment of relevant controls against MHRA, ICH Good Clinical Practice (GCP) and 21 CFR Part 11 principles.

Florence is available to authorised individuals involved in the conduct, management, oversight, monitoring or audit of eligible studies at Barts Health. 

Access is role- and study-specific. Users are assigned permissions appropriate to their responsibilities and must complete the relevant training before access is granted. 

A user may therefore have different permissions for different studies depending on their responsibilities. The role-based approach and ability to assign different permissions across studies were confirmed during the Florence implementation discussions. 

Florence is currently being implemented for eligible new studies at Barts Health as part of a phased rollout. 

Yes. Florence has functionality designed to support the management of electronic clinical research records in accordance with applicable regulatory and Good Clinical Practice requirements. This includes role-based access controls, audit trails, electronic signatures and document version management. 

Barts Health has undertaken local validation and readiness activities to assess Florence for its intended use. Internal validation documentation records assessment against MHRA, ICH GCP and 21 CFR Part 11 principles.  

The electronic signature functionality used within Florence at Barts Health has also been assessed for use in accordance with 21 CFR Part 11 requirements. Local requirements for using Florence and electronic signatures are set out in SOP 50 and its associated guidance.  

However, use of a validated electronic system does not by itself ensure regulatory compliance. Study teams remain responsible for ensuring records are complete, accurate, attributable and maintained in accordance with applicable regulatory requirements, the protocol, sponsor requirements and Barts Health policies and procedures. This responsibility is expressly reflected in the local Florence governance guidance. 

Users must complete the Florence training appropriate to their role before access is provided. 

Once the relevant training has been completed, please provide evidence of completion to your local Florence Champion. The Champion will arrange access and assign permissions appropriate to your study role. 

 A list of Florence Champions can be found here.

All new Florence users must complete the required Florence training before access can be granted (details can be found here [insert hyperlink to Training document]). Training is designed to provide an understanding of system functionality, document management expectations, and local processes. Additional training may be required if you accept more responsibilities. 

Yes. Florence Champions play an important role in supporting the successful adoption and consistent use of Florence across Barts Health. As Champions are often looked to for advice on local processes, best practice, and document management, the role is typically undertaken by experienced members of research teams who have a strong understanding of Florence itself as well as research delivery and governance requirements. 

 Champions are expected to: 

• Be confident and experienced users of Florence. 

• Have a good understanding of local research processes and documentation requirements. 

• Be recognised within their area as a trusted source of advice and guidance. 

• Support colleagues in adopting best practice. 

• Act as a liaison between their local teams and the central JRMO team. 

While the role is generally most suitable for experienced staff with established responsibilities within their department, we welcome expressions of interest from anyone who is enthusiastic about Florence and interested in helping to support its use. If you would like to become a Champion, please contact the JRMO to discuss the role. 

Florence Champions are experienced users who act as local points of contact within their department, speciality or research team. 

Depending on their assigned responsibilities and permissions, Champions may: 

• Set up new eISFs using the approved structures and templates. 

• Manage access and assign appropriate user roles and permissions. 

• Support users with Florence processes and day-to-day system queries. 

• Support consistency in the use of approved logs, templates and filing structures. 

• Identify issues and escalate them to the JRMO Florence team where appropriate. 

• Share learning and good practice with other Champions and the central Florence team. 

Champions support the operation of Florence locally, but responsibility for the conduct of the study and oversight of its essential records remains with the appropriate investigator and study team.  

A list of Champions per area can be found here [insert hyperlink]. Florence Champions are experienced users who provide local support, advice, and guidance to research teams within their department or speciality. If your area does not currently have a Champion, please contact the JRMO at research.florence@qmul.ac.uk. 

Authorised sponsor and Contract Research Organisation (CRO) monitors can be provided with controlled access to the relevant Florence eISF. 

Once monitors have completed the required training and provided a copy of their certificate to your Florence Champion, they will be provided with access to the relevant eISF and staff training records. Monitors can raise queries and complete the monitoring visit log, but cannot manipulate documents within the eISF. Read-only access can also be granted to auditors and inspectors (but these roles cannot raise queries). 

Auditors and inspectors can similarly be provided with appropriately controlled access when required.

Florence is intended for the management of essential study documentation and should only contain information required for the conduct, management and oversight of the study. 

Documents containing personal or confidential information must only be uploaded where this is appropriate and permitted by the study protocol, sponsor requirements, information governance requirements and Barts Health policies. 

Florence should not be treated as a replacement for the patient's electronic medical record. Barts Health does not currently import complete patient medical records from PowerChart into Florence, and source data verification may therefore continue to require access to PowerChart. 

Where participant-related documentation needs to be maintained within the eISF, only the information required for that purpose should be included and it must be handled in accordance with the applicable information governance and study requirements.  

Barts Health does not currently use the Florence eConsent module. Participant consent should therefore continue to be obtained and documented through the process approved for the individual study. 

The eISF must be retained for the period required by the applicable regulatory, sponsor and organisational requirements. 

At study close-out, access to the Florence eISF can be restricted so that records remain available to appropriately authorised users while being protected from inappropriate access or alteration. 

Importantly, archiving in Florence does not determine how long study records need to be retained. The applicable regulatory, sponsor and organisational retention requirements determine the retention period. 

Internal Florence discussions have confirmed that archiving operates primarily through controlled permissions and that Florence does not automatically determine when records should be destroyed. Study teams should therefore follow the applicable Barts Health/JRMO archiving and retention procedures when the study closes. 

The proposed use of Florence should be discussed with the sponsor where sponsor agreement is required. Sponsor-specific requirements should be identified before the study is set up in Florence. 

Barts Health's current position is that Florence is the standard eISF platform for eligible studies unless a specific sponsor, regulatory or study requirement prevents its use.  

Where a sponsor proposes an alternative approach, this should be discussed with the local Florence Champion or JRMO Florence team before another system or paper ISF is established. 

The aim of Florence is to provide a controlled electronic location for the study's essential site documentation rather than create duplicate electronic and paper filing systems. 

Where an original record legitimately remains outside Florence, its location and management should follow the applicable study, sponsor and local requirements. 

Study teams should avoid unnecessary duplication of controlled records across systems because this can make it unclear which record represents the current or authoritative version. 

Yes. Florence provides electronic signature functionality, and Barts Health has established local requirements governing its use through SOP 50 and the associated Florence governance guidance.  

Users must use their own Florence account and credentials when performing electronic signature actions. Electronic signature events are captured within Florence's audit trail.  

Users should follow the applicable SOP when deciding when and how an electronic signature can be used.