By: Anthony Warchut, Vice President Technical, PAREXEL® Consulting
Do you think that the paper printouts from diagnostic equipment used to generate data in a clinical study is source data? Regulatory authorities may have a different opinion. The answer is dependent upon the piece of equipment, whether it stores raw data electronically that is used to create the paper printout and if that data is dynamic. A recently published GXP Data Integrity Guidance document provides a clear definition of ‘source data’. Many sponsors and clinical sites arbitrarily decide that the paper printout is the source data because that is the easy way out. However, if the piece of equipment stores raw dynamic electronic data that is used to create the paper printout, you are at risk to receive an FDA-483 observation concerning the integrity of that data. The three pillars of clinical studies are protecting subject safety, rights and the integrity of the data being generated. Protecting the integrity of electronic data from a clinical study is an important aspect of the study, especially if it is related to a primary or secondary clinical trial endpoint. This data is just as important to support your application, as it is in a Quality Control Laboratory where regulator have been focusing a great deal of their attention on data integrity. Regulators around the world are very concerned about the integrity of the data upon which they make their decisions to approve or reject a marketing application. It’s only matter of time before regulators increase their attention on the integrity of electronic data generated from clinical trials. Don’t wait for FDA, MHRA, EMA, TGA or another regulator to find this type of potential data integrity issue. Now is the time to review your policies and procedures regarding raw electronic data generated as part of a clinical study.
For more on this topic, read the full article on what data integrity aspects you need to be evaluating when conducting this review in order to determine if you have adequate controls currently in place.