Why do you need an eTMF?
As we have previously discussed before, regulators expect pharma companies to demonstrate control over their TMF content. Inspectors want to see GCP compliance demonstrated by the documentation compiled in the TMF. This means that the protocol was followed, patient safety was maintained and the data collected can be used to support the trial analysis.
When is a TMF archive appropriate?
• Your company is just starting up (not many trial documents have been processed)
• Your company outsources everything to a CRO
• Your company can’t afford or support a full-service eTMF
What do inspectors expect from an archive eTMF
- Security/Access Control
- SharePoint has out of the box functionality that can be adopted to create user profiles and corresponding permissions. These basic features can be expanded to control access to specific studies or content within SharePoint. Many companies have existing integration with Active Directories and/or Single Sign-on systems to allow users to easily logon to the SharePoint eTMF application.
- Validated Status
- SharePoint has been extensively validated by many organizations within life sciences. You will want to validation any custom configurations such as picklists, templates used to create subsites and workflows. It is not difficult to create a simple validation plan and associated test scripts for this functionality
- Back up/Disaster Recovered
- Microsoft Online offers defined service level agreements for backups (every 12 hours and the time to recover data (14 days). Microsoft has a defined incident management process and appropriate training of their staff to handle these situations. This situation is ideal for the smaller companies that may not be able to support a disaster recovery program by themselves.
- On-Premise SharePoint supports a more custom tailored approach to backup and restoration. The On-Premises solution requires more from your internal support team’s capabilities. This can allow sharing costs and policies across the enterprise needed to enforce your compliance standards.
eTMF Content Control
- A simple pick list of metadata can be created from the TMF Reference Model Artifact data. This metadata can be applied to each artifact when it is created or uploaded into the SharePoint eTMF. Other useful metadata may be the study site, country or Primary Investigator that is associated with the document. The metadata is important for filtering and sorting the data in the eTMF system. Metadata also is useful when the data is exported as a list from SharePoint.
- Version Control
- SharePoint can be configured to just manage major versions, or minor and major versions. Most archive eTMF solutions don’t plan for document edits, so working with major versions can be adequate. The system can also be configured to check for duplicate files names when uploading new content.
- Once all of the content for the TMF has been received, the workspace can be locked to avoid edits. In addition, use permissions can be set to read-only to ensure the content is not edited.
What other features does SharePoint provide that help your organization as an eTMF archive?
Ease of Administration
- Sub-site or Workspace Creation
- By creating a template to be used for creation of new study sub-sites or workspaces, the time to setup a new study can be greatly reduced. User permissions, folder structure, views, lists and picklists can all be configured in the template. This reduces human error in the creation process and provides the users with a consistent user interface.
- SharePoint offers basic and advanced search features. Both search types provide facets or refiners that can be used to narrow the search results. This area can be optimized as more content is available and the metadata can be used to help the users find the results they are seeking.
When not to use SharePoint?
- Do not use SharePoint when you want an active eTMF such as:
- Review and Approval Workflows are needed
- Electronic signatures are required
- Detailed reports and metrics are required
- Repository access is required for site personnel
SharePoint can provide many benefits over a file share with regard to eTMF management. This can provide a stepping stone for those organizations considering the purchase of an eTMF system, but who cannot fulfill that goal due to a variety of reasons. The goal with the SharePoint eTMF system is to start with a small set of user requirements that able the initial design and configuration of the system. The limited initial design can be validated with a minimal effort. As users adopt their business process, become more familiar with the TMF Reference Model and the SharePoint features, then system enhancements can be made to meet the business needs. Metadata management of artifacts in the TMF Reference Model and electronic workflows can provide additional benefits to moving the organization toward an active and paperless TMF.