Continued from Part 1…
Objection 2: “It’s an approved device!”
Well, let’s hope so! The question is, “Approved for what?” And the answer is nearly always that it’s approved for use in clinical practice. But…
Clinical Practice ≠ Clinical Research
Clinical research is subject to higher data integrity requirements than clinical practice. Remember – the clinical trial subjects (whether we call them participants, subjects, patients, or volunteers) are experimental units in a scientific experiment. We must do them the honor of making sure their contributions to the experiment have integrity.
Thus, work with the lab to identify the source of the problem:
- Did the lab simply neglect to configure the instrument properly?
- Is it a manufacturer’s design problem?
The solution may be simpler than you think. And the good news? Device and instrument manufacturers are listening!
It’s becoming increasingly common to see newer devices and instruments with far better controls. Look for this as you qualify your clinical labs.
Objection 3: “Our raw data are paper.”
This is the result of misunderstanding an old guidance document about 21 CFR Part 11. For paper records to be equivalent to paper printouts, the paper printouts must be equivalent in content and meaning to the electronic records.
Can your auditee demonstrate this is the case? Can you demonstrate that it’s not? In some cases, demonstrating the negative is pretty easy. (Remember: duplicates are only duplicates if they’re the same. See Finding B.3.c in this Warning Letter.)
Even more important, what do people rely on to perform regulated activities? It’s almost certainly the electronic records, not the paper:
- When was the last time the lab’s Data Management department used paper records to prepare your file for transfer?
- When was the last time your Data Management department received paper printouts from a central lab and double data entered the results in a clinical database?
- Nope. We all rely on the electronic records. Here’s FDA’s current thinking on paper records in the GMP environment (See Question 3).
Thus, compare paper record to electronic records to demonstrate why they are not equivalent to electronic records. Discuss the fact that neither central lab personnel downstream from the instrument in the lab, the sponsor, nor the investigator rely on those instrument printouts to perform their regulated activities.
MHRA Steps Up With Data Integrity Guidance
In 2015, the MHRA published a very helpful guidance on data integrity in the GMP environment. The latest revision discusses how to deal with computer systems that do not currently support adequate audit trails or logical security controls, any of which could be applied to a clinical lab.
Keep in mind: Regulators will certainly continue to take action when they see evidence of data integrity problems that are institutionalized, endorsed by management, or the result of collusion or fraud.
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About the Author
Jamie Colgin is FDAzilla’s GCP Product Manager and joins us from Colgin Consulting, Inc.
She is the recipient of the prestigious Charles H. Butler Excellence in Teaching Award.