SureClinical’s SureArchive Cloud Service enables the secure, long-term retention of clinical trial documents, accessible online for instant viewing and sharing by your clinical study team, auditors or regulators. Typically clinical trial data must be accessible over the long term, with the terms being largely dependent on the governing regulatory agency. For example, the FDA requires investigators to retain clinical trial documentation for a period of two years post marketing approval, whereas the Canadian GCP stipulates that sponsors must keep trial documents for a period of twenty five years.
Given these regulations and the associated requirement to deliver archived documents to inspectors upon request within relatively short periods of time, sponsors are seeking ways to meet their archiving requirements through the application of cost-effective, cloud-based solutions. The SureArchive Cloud Service provides sponsors with an accessible yet indelible clinical trial document archive, offering sponsors assurance that their document management regulatory obligations are being met and ensuring the integrity of their records. Inspectors and other authorized study personnel can access and search for archived clinical trial documentation online instantly, without the time consuming job of sifting manually through paper records in a physical storage facility.
SureArchive is available as a cloud subscription service, offering read-only access to the trial documents to authorized personnel. The SureArchive solution supports two main scenarios :
- Sponsors have received marketing approval for their drug, therapy or device and would like to switch from their SureClinical cloud service to the long-term SureArchive solution.
- Sponsors have old, paper-based study documentation and would like to move towards a fully electronic, online system for the secure maintenance of trial documentation.
In either case, full SureClinical functionality is provided for the transitional period, enabling documents to be uploaded and classified in a standards-based eTMF filing system. After the documents are captured in SureClinical eTMF, the repository converts to a read-only archived state.
Ensure Clinical Study Archive Integrity with a Certified Archive™
In addition to storing documentation online, SureClinical eTMF and SureArchive both allow for documents to be exported at any time to various standard formats, including the well-established ZIP/HTML/PDF and PDF Portfolio formats, at no extra charge. Securing exported documents is easy with the integrated archive encryption feature, helping to ensure compliance with HIPAA and other regulatory compliance laws requiring data security and privacy. File content tree structures, documents and associated metadata are included in these portable exports, enabling large archives to be burned to golden DVD’s for added redundancy, long term storage and risk management.
The exports of digitally-signed documents and records to a digitally-signed PDF portfolio format provides additional archive integrity and assurance of the originating party. This technology is referred to as SureClinical’s Certified Archive™ format. A certified archive is a collection of PDF documents and clinical trial metadata records that are digitally signed by the originator. The certified archive can be viewed by any third party recipient in both online and offline modes via the SureArchive cloud service or in Adobe Acrobat or Adobe Reader. When the recipient opens a digitally signed archived document, all documents are tested for integrity to determine if they have been modified since creation. The archive author’s identity can be verified by the viewer through a third party certificate authority, similar to how an SSL certificate is used to verify the identity of a website.
- Instant online access to archived study documentation
- Compliance against regulatory document retention requirements
- Ensure full, long-term access control over clinical trial documents
- Preserve important clinical trial records from the SureClinical eTMF cloud repository
- Minimize risk of loss of critical clinical trial records
- Minimize paper storage costs by using an all-electronic format
- Ensure long-term archive integrity and reliability
- Online, secure read-only access to archived clinical trial documents for viewing and sharing content
- Full use, transitional period for establishing the SureArchive repository
- On-demand creation of secure archives from cloud documents and records to offline media such as CD/DVD
- Create a digitally-signed Certified Archive™ which ensures archive integrity, reliability
- Integrated trust verification feature lets recipients instantly verify who created the archive
- Encryption of archives is FDA and HIPAA compliant and ensures security when sharing archives
- Export wizard enables bulk save and export of archived documents to PDF/A format
- Export to native .SAVE format, Certified Archive™ format (compatible with Adobe PDF format), HTML format (.ZIP)
- View archives in SureViewer™, Adobe Acrobat or Reader, or Web browser.