The audit trail: a digital trail of cookie crumbs that effectively illustrates the path taken to get to where you currently are. In a literature review, an audit trail is a relatively new concept in the grand scheme of things. Older literature review methods, like using a pen and paper or even a computer spreadsheet, did not have such features. But with today’s increasing regulatory standards and the need for transparent and rigorous evidence-based research, the audit trail has become a critical component to any literature review, regardless of your industry or purpose.
Here are a few reasons why an audit trail is needed for any literature review:
1. The Regulatory Perspective
Organizations that report to regulatory bodies need to follow specific standards when it comes to their reporting. An audit trail is something that regulators and notified bodies (groups in charge of assessing conformity of products on behalf of governments) look for. Audit trails provide a comprehensive, unassailable record of the methods and processes used in the review. Since everything is documented, it’s easy for an auditor or notified body to confirm that the research was conducted according to required standards and best practices. It allows them to trust the data and findings being presented.
For example, let’s take a look at the new European Union Medical Device Regulations (EU MDR) coming into effect this spring. MDR notified bodies are looking for many specific things in their assessments, and a transparent clinical evaluation report (CER) process is one of them. An audit trail that utilizes user, date, and timestamps is as transparent as it gets. Also, the act of automatically recording everything makes sure everyone on the team is following the proper protocol. The major purpose of an audit trail, in this instance, is having the ability to answer questions efficiently and accurately in conformity assessments. ‘Who reviewed this reference?’ and ‘When was this work completed?’ are both questions that can be quickly answered thanks to an audit trail.
2. The Efficiency Perspective
If you took a peek at our Timeline of AI in Systematic Reviews, you’d see that as recently as 20 years ago, researchers were still doing literature reviews with a pen and paper. Later on, when using spreadsheets to complete literature reviews became the benchmark, we were able to work a little bit faster. However, there was still no version control or audit trail, which often led to mistakes that were hard to identify and even harder to fix. This could sometimes result in hours, days, or even weeks of extra work.
An audit trail not only protects organizations who need to follow stringent compliance standards, but it also helps teams collaborate better and faster. Timestamping and user stamping ensures that every change made to the data is noted. That way, if there is an error, it can be found and corrected quickly and efficiently, with a full record of any corrections made.
3. The Data Preservation Perspective
In today’s data-driven world, the concept of “data security” is something that comes up quite a bit. For organizations performing literature reviews, data integrity is critical and needs to be protected. The primary function of an audit trail in literature reviews is to help improve efficiency and transparency, but it also helps preserve data provenance, tracking all changes and preserving every version of the data throughout the change process. These types of “digital forensics” are important for organizations that deal with data that informs policy and guidelines or organizations that could be the subject of legal proceedings.
Are you fully documenting your literature review process? If you don’t have an explicit and easy-to-follow audit trail, you could find yourself in trouble. Learn how DistillerSR maintains an automatic audit trail and full data version control within the software, so you and your team can always follow the proper protocol and show transparency in your work! Request a free DistillerSR demo here.
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