The Evolution of Clinical Trial Data Collection
Clinical trials have come a long way since the days of collecting and documenting the entire trial on paper. Using electronic data capture tools that allow you to build in edit checks and automatically generate queries, we ensure that the data collected for trials is cleaner, better data right from the start. Though it was a long, slow process to get the industry to move from paper to paperless, we finally got there, and thank goodness we did! If we can advance the processing of clinical data in this way, it’s time we advance the vendor audit process as well.
Challenges of Traditional Audit Processes
As Sr. Director of Compliance at OpenClinica, I perform and host many audits throughout the year. As an audit host, the typical process has been that a customer auditor reaches out to schedule a two-day audit. Shortly before the audit they’ll send an agenda. During the scheduled two-day audit, they review:
- standard operating procedures (SOPs),
- validation documentation,
- supporting documentation demonstrating SOPs are followed,
- training records,
- employee CVs (curriculum vitae),
- job descriptions, and
- much more.
Along the way, auditors ask questions and get clarifications. This approach unnecessarily limits the time to review the documentation and to get a more thorough review of our procedures and evidence.
The above process is based on the days of on-site audits reviewing paper-based documentation. I lived through those days when audit hosts would arrive with a cart full of binders with all their SOPs, validation documentation, training records, etc., and there was limited time to review all that documentation. Though this was an inefficient and time-restricted process, since everything was on paper, we didn’t have a choice. We now have options, but for some reason, many are still processing audits as though we’re still working with carts full of binders.
OpenClinica’s Transparent Approach to Audits
This was the most efficient process of any audit I’ve ever done – Auditor
Why limit the auditor’s time with documentation? Why limit the response time of the auditee to 1-2 days? Why get a less thorough review of the vendor? All audits capture a snapshot in time, but why not capture a panorama with zoom capabilities?
OpenClinica has long been ahead of the curve regarding transparency with customers. The Regulatory Support Package (RSP), which is available to customers 24 x 7 x 365, includes access to:
- OpenClinica’s Quality Management System (QMS)
– Includes the quality manual and all related standard operating procedures - Development documentation, including:
– release plan,
– product requirements/test plan,
– traceability matrix,
– quality summary,
– applicable notes to file, and
– release notes.
This approach made performing the audit more thorough and efficient – Auditor
Advantages of Open Access to QMS & Development Documentation
There’s no need to submit a request for access to any of the above – it’s part of the “Open” in OpenClinica that we share this documentation with our customers so they can review it as widely and deeply as they need. In addition, when a customer does want to perform an audit, we share a folder in advance and request that customers let us know any additional documentation they’d like to review.
Typically, this includes training records, CVs, job descriptions, organizational charts, and more (in a recent audit, there were 47 additional documents requested and shared). We’re happy to share that information prior to the scheduled audit date(s). Auditors then review the documents as their time allows, and as deeply as they’d like. They let us know if they have any questions or additional requests as they read through the documents, and we’re happy to respond.
During the scheduled audit time, we can tie up loose ends and review any findings/recommendations. In my experience with this approach, though the documentation review may span a number of days, the total time invested still tends to be less than the typical two audit days, and the review is much more thorough.
Towards a More Efficient and Thorough Audit Process
Though our transparency is for our customers’ advantage, we also have selfish reasons for being so open. The more eyes we have on our QMS and development documentation, and the deeper the dive an auditor can take, the better the feedback we get. We can then incorporate that feedback into our continuous improvement program and do even more to support our customers.
As an industry veteran, I’ve never known another organization to share their QMS and development documentation so openly, and I’ve never understood why. At OpenClinica, we want our customers to have access. We’ve already done a great deal to move the industry forward as far as getting better data, faster. We’re well beyond the days of paper-based processes, yet audits still follow a paper-based approach.
It’s time to take advantage of the open access to our QMS and development documentation, to request and review additional documentation prior to the audit, and for us all to get the benefit of better audits, faster.
Interested in learning more about how we support our customers through their audit cycles? Contact us!
About the Author:
Laura (Loa) Keita has been in the industry since 1980 in various roles, including programming, software development, documentation, training, computer system validation, and – always – compliance. Laura has worked at many large pharmaceutical companies as well as large and small EDC and RTSM software companies, and she has been on both sides of the audit table throughout her career.