Endpoint Clinical Achieves More Compliant Audit Data Submission with Egnyte
In the view of global regulatory bodies, digital transformation in clinical trials has placed increasing significance on the link between audit trails and data integrity. The Food And Drug Administration highlighted audit trails in their 1999 guidance on the use of computerized systems in clinical trials. Seventeen years later, amid increased regulatory scrutiny regarding data integrity and computerized systems in clinical trials, the International Council for Harmonization released an addendum to ICH E6 (R2) to help the industry implement “improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure… reliability of trial results.”
The addendum focused prominently on the need to verify data integrity through audit trail review in trials that use computerized systems – and as digital transformation has brought these systems to every corner of the clinical trial process, researchers are increasingly cognizant of the role of technology vendors in the secure submission of audit data. Against this backdrop, Endpoint Clinical, an Interactive Response Technology (IRT) provider, joined forces with Egnyte to streamline the provisioning of audit trail data to investigators and regulators in an increasingly computerized clinical trial landscape, leading to more effective and accurate compliance for all stakeholders.
Challenge: Reduce Risks to Data Integrity at Trial Closeout
Audit trail review is no longer solely the domain of electronic data capture platforms. Today’s clinical trials are supported by a network of eClinical technologies including eSource, Patient Reported Outcomes, Clinical Trial Management Systems, and IRTs – all of which are now recognized to host the authoritative source of a variety of clinical trial data points that may be digitally copied into an EDC system and thus subject to audit trail review. As this shift has played out, regulators have emphasized that investigators should own the clinical data and have access to, and be able to review, audit trails.
This presented a challenge for Endpoint Clinical. At trial closeout, IRT vendors typically provide audit data to investigators through the trial sponsor, who acts as an intermediary. However, the involvement of sponsors in the transmission of audit data has raised regulatory concerns around data integrity. Sponsors’ vested interest in gaining market approval of the products being studied conflicts with regulators’ demands that audit log data be presented without bias. Given the importance of audit logs for maintaining data integrity, regulatory bodies would prefer to restrict audit log data to more neutral parties and avoid any possibility, however remote, of data being modified to better support approval.
But cutting sponsors out of the process was not a viable solution. “While data integrity concerns all but preclude sponsors from acting as intermediaries in the delivery of audit log data to regulators, they still need to have oversight of the overall process,” explains Cat Hall, Vice President of Data and Quality at Endpoint Clinical. “Our job was to find a way to strike that balance, to give them the oversight they need without having to be so involved in the process that regulators feel uncomfortable.”
Solution: Streamlined Audit Data Submission Eases Regulators’ Concerns
To strike this balance and maintain compliance, Endpoint Clinical partnered with Egnyte to build a platform that would enable them to provide audit trail data directly to investigators – without hands-on involvement from the sponsor. “Our goal is for the platform to enable sponsors to fulfill their obligation to provide oversight of the audit data delivery process without having to act as a hands-on intermediary,” explains Hall.
Endpoint’s Audit Data Management platform, powered by Egnyte’s cloud file solution, delivers three key benefits:
- GxP compliance: Data captured is traceable, accountable, and complete, and the platform provides full visibility into how the data has been altered and who has accessed it. As Hall puts it: “We’re able to deliver an audit log that provides everything investigators and regulators need to be able to see, with no blind spots.”
- Controlled access: Investigators have access to site-specific data, with granular permissions controls ensuring that the data is only accessible to the proper stakeholders and in the proper manner. “Partnering with Egnyte allows us to give one stakeholder edit access to a file while making sure another only has view access,” Hall explains.
- Peace of mind: Sponsors have documented proof that the audit log was distributed to the investigator. “This documentation provides sponsors visibility into the process, and confirmation that everything was handled properly, without having to be directly involved,” says Hall.
Benefits: A Powerful, Compliant Offering for Endpoint Clinical’s Clients
The Audit Data Management solution, powered by Egnyte, enables Endpoint Clinical to streamline operations for their clients at a critical juncture in the clinical trial process, with benefits extending to a wide variety of stakeholders including sponsors, investigators, and regulators. “Sponsors can now fulfill their obligation to provide oversight without being an intermediary,” says Hall. “They can receive assurances of ALCOA-plus principles while keeping a safe enough distance from the delivery of audit data to ameliorate any concerns about data integrity.”
This has made Endpoint Clinical uniquely capable of overcoming a particularly vexing compliance challenge in the current digital era of clinical research. The impact to their business is hard to overstate: “We’ve had contact with sponsors and investigators alike who are now eager to work with us,” Hall says. “By combining our IRT with Egnyte’s powerful cloud file system functionality, we’re able to help these organizations solve a puzzle they’ve struggled with for a long time.”
Benefits for Endpoint Clinical’s clients:
- Full GxP compliance
- Controlled access to site-specific data
- Proof that audit log data has been provided to investigators
GxP with Governance
Controlled External File Sharing, GxPLearn More