Devices and equipment are absolutely essential to the success of a clinical trial. However, their accuracy and precision does tend to shift over time and with repeated use.
This is where calibration comes into play. The goal of calibration is to ensure that any uncertainty in device and equipment measurements are minimized. To do this, measurements made by a device are compared against a reference instrument or standard to check precision, accuracy, and limits.
Calibration & Clinical Trials
Properly calibrated devices and equipment are critical in a clinical trial environment. Per ICH GCP 8.2.12, any medical, laboratory, technical procedures, or tests require some type of certification, accreditation, established quality control process, external quality assessment, or other validation to document the competence of a facility to perform required tests and support reliability of the results.
Calibration is done according to schedules that are dictated by your research site's internal SOPs or clinical trial protocols. For example, a protocol might dictate a certain speed for a centrifuge. Documentation regarding device and equipment calibration & validation should always be available in case of an audit or inspection.
Devices and equipment that have been calibrated typically have a sticker placed on them that is initialed, dated and states the next date that they are to be serviced.
Remembering to Recalibrate
Here's where it gets hard - how do you remember when to schedule the next calibration date? Most study sites do one of the following:
- Trust that their calibration vendors will remember in time.
- Set calendar reminders (which can quickly get annoying if you have lots of things that need to be recalibrated).
- Track device and equipment recalibration dates in a spreadsheet.
- Use a platform like Slope to track device and equipment recalibration dates, and assign specific team members to respond to alerts when they are generated.
Missing a recalibration date for a piece of trial equipment can have cascading consequences that introduce your research site to a tremendous amount of risk. The most important step you can take today is rechecking your SOPs, educating your study team, and ensuring that a consistent process is always followed.
Written by James Irvin
James Irvin is Slope's VP of Customer Success. He works with study sites around the world to build scalable and adaptable inventory management solutions.