ALCOA outlines the FDA’s expectations for data integrity. It defines the types of records the government wants: Attributable, Legible, Contemporaneous, Original, and Accurate. What these guidelines don’t prescribe is a standard for clinical sites to collect this data.
The FDA makes no differentiation between paper and eSource systems, but that doesn’t mean that you shouldn’t know the difference. According to CenterWatch News Online, 93% of sites have used electronic data capture at least once—and for good reason. eSource outperforms paper for ALCOA data integrity. Here’s how:
Research sites must attribute all data to the individual who collected it. Signatures and dates on paper have always been the gold standard for this. However, verifying written signatures can be difficult, and signature forging is always a concern. File cabinets and clipboards are hardly impenetrable.
Implementing eSource can improve this process and its security. The best eSource solutions will offer password protection for different users, as well as notifications and signature reminders. Sure, your attribution paper trail will no longer be on actual paper, but it will be safer.
Handwriting is unique, which can lead to some uncomfortable situations when you receive your colleagues’ illegible notes. When you implement an eSource tool, it will eliminate these legibility issues due to its entirely digital nature.
Utilizing eSource provides documentation that is clean, consistent, and standardized—and that’s better for everyone.
Data is contemporaneous when it’s recorded as the action that created it takes place. If you focus on the patient—and not the process—you may miss out on how important it is that data is recorded right away. That’s understandable, but not ideal for ALCOA data integrity.
You can avoid this problem with eSource! A good electronic program will capture important aspects of clinical research like user information, time, and date at every point of your interaction with a patient, ensuring you record key data as it happens.
Original refers to where a data point is first recorded. Choosing a paper source for original data could create trouble in the future, since a paper-based system may be susceptible to physical damage from floods, fire damage, or other unpredictable issues.
eSource data, on the other hand, is not easily destroyed. The key is to select a cloud-based eSource vendor that offers backups and redundancies. That way, even if one server is threatened, another server will have a copy of your original data.
Even with the proper instructions and training, your staff may still fill out paper forms incorrectly. An eSource tool can help ensure data integrity by providing helpful hints at key moments during entry. For instance, let’s say you enter a subject’s weight in pounds instead of kilograms. A good eSource solution will catch this error and warn you that the value is out of the expected range.
Maintaining ALOCA throughout your clinical trial process is important, and utilizing an eSource solution is one of the best ways for your staff to keep the FDA expectations at the forefront of their minds.
Learn more about the benefits of eSource options with this webinar from our CTMS Resources series.