7 Ways to Ensure Data Integrity in Clinical Research

Clinical trials are necessary for advancing the medical treatments available to patients, and data integrity is essential to ensuring these trials are reliable and accurate. Unfortunately, data integrity can fall victim to a number of issues, including:??

• Data entry and transfer errors??

• Inadequate data documentation (i.e., missing or incomplete data records)?

• Data falsification and fabrication?

Here are 7 ways to protect the integrity of your clinical data and your research:?

1. Data Entry Training: It may seem obvious, but properly training all of your data entry staff in your entry SOPs will not only reduce errors, but it will make errors that do occur easier to catch.?
2. Data Validation Protocol:?In addition to your entry SOPs, you should have one that outlines your data validation process, ensuring that errors and inadequate documentation are caught quickly (and needs for additional entry training are identified.)??
3. Error Handling Mechanism:?Having a process for reporting and tracking entry errors will enable you to track the source of errors and address them systematically. Put an SOP in place and train your staff on what to do when errors are found.??
4. Access Control: Ensuring only authorized personnel can access or modify the data will prevent falsification or fabrication by bad actors. Make sure to take full advantage of any access controls your system provides.?
5. Data Encryption: Converting sensitive and confidential patient data into a coded language that requires a decryption key will further safeguard access and protect against data falsification.?
6. Audit trails and logs: Keeping track of when changes are made and by whom will enable you to track down the source of errors or falsifications.?
7. Data versioning and time stamps: Keeping prior versions of your data will enable you to roll back to a known correct version when needed.?

Protecting the data integrity of a clinical trial is important to the reliability and accuracy of the trial, and doing so provides confidence in the medical treatment itself. With assured integrity, the FDA approval process becomes easier, and potential patients can have confidence that the drug is safe and effective. ?