Data Integrity in Clinical Trial through IRT
What is Data Integrity?
Integrity of data is ensured only when initial remains valid throughout the product life cycle. If the accuracy comes under question at any point in time then data integrity would collapse. ALCOA system is the best method of defining and measuring data integrity. It can be broadly expressed as:
Technology Driven Automation
Attributable: A single person to be held responsible and accountable from the beginning to the completion of a particular task.
Legible: The data gathered should be clear and simplified so that it is easy to read and conceive and can be preserved for future usages.
Contemporaneous: The data created and the activity conducted need to be running simultaneously i.e., in real-time.
Original: The data should be authentic and its validity to be maintained throughout the product life cycle.
Accurate: Resemblance of the task and data is necessary to prove accuracy.
IRT’s Impact on Data Integrity
a. Managing of Blinds
Interactive Response Technology (IRT) helps in systematically maintaining data blind. All the data starting with assignment of treatment and continuing towards ultimate data analysis can be easily viewed in the audit trail timeline. Unblinding of data is generally the outcome when there is no or a poor IRT system in effect. Finally, it is the responsibility of all the stakeholders to pay special attention while the blind is being enforced so that it can be maintained all through.
b. Streamlining Audit Trail
Data of Audit Trail are extremely significant as later inspections related to pharmacokinetic studies; randomization or a double-blind could be benefitted from it. The final data can be reviewed by comparing the source data with the end data. It is enough to reveal whether the subjects received opposite treatment meaning active drugs and not a placebo or they received mixed treatment where they were given both active drug and placebo or the drugs were given under wrong dietary conditions like dosage to be given in fasting were given after feeding and vice versa. IRT system makes it easier to trace all these details through the audit trail so that issues can be handled on time rather than discovering them during an inspection.
It is data integrity that the entire industry is concerned about and IRT systems will ensure it only if it is properly verified. So, for vendors it is of utmost importance to verify the IRT not only for vendor qualification but also during the implementation of protocol change or any such other changes. This will ensure that the data that you retrieve is completely integrated.