Drug Accountability & Reconciliation Tracking (ART™) in Clinical Trials
The drug accountability and reconciliation process in clinical trials is noted for being time-consuming and error-prone, two characteristics that result in it adding significantly to trial costs and timelines. The onerous task of reconciling discrepancies in supply records that have accumulated over the course of a clinical trial often adds as much as two years to the study closeout phase.
When a work process is viewed as a “necessary evil,” it’s time to innovate. Time to automate. Time to streamline. For the industry’s drug accountability and reconciliation procedures, that time has come.
Almac Clinical Technologies’ drug Accountability & Reconciliation Tracking (ART™) functionality within IXRS® 3 Interactive Response Technology (IRT), does away with the paper records, transcription errors, and multiple systems that lead to missing data and errors. With ART™, you reduce risk to patients, speed trial close-out and prevent the kinds of issues that lead to warning letters from regulators.
Adding the ART™ functionality to IXRS® 3
Protects patient safety
Real-time validation checks throughout all medication-related events and visibility into the condition of drugs throughout the supply chain reduce the opportunity for patients to be given the wrong or unsafe medication. Should there be a safety issue, you can quickly perform a root-cause analysis through a comprehensive “Kit History and Custody Report.”
Because the software captures both the drug assignment (within the core IXRS® 3 functionality) and details on the investigational product that is administered to the patient and subsequently returned, it serves as an extra step to ensure that what was dispensed to, and consumed by, the patient followed the protocol. Non-compliance is reduced and highlighted.
Capturing drug accountability and reconciliation information in the IRT, eliminates transcription errors, and the challenges and inaccuracies that stem from paper processes. Compliance is improved and risks to the trial are greatly reduced.
Improves completeness and accuracy of accountability data
The system guides site users through the process of documenting returned investigational product (used, unused, missing and damaged). Users are “forced” to complete all of the required fields, and logic checks prevent data entry errors.
Speeds study close-out
When used as the primary method for accountability data capture and reconciliation, IXRS® 3 prohibits users from entering erroneous data which prevents discrepancies from occurring and greatly reduces time spent on drug reconciliation during the closeout phase.
Streamlines operations/reduces costs
The tedious and time-consuming steps in reconciling discrepancies that appear in paper records, or records kept in multiple systems are all but eliminated. Site monitors can use their time more productively, focusing their attention on potential problem sites/procedures. The time spent at sites, therefore, can be reduced dramatically.
Support for Risk-Based Monitoring
IXRS® 3 enables the adoption of a risk-based approach to monitoring, providing a drastic reduction in billable hours of costly resources. Site monitors can receive alerts when drug accountability discrepancies appear (for example, if investigational product return counts are not in accordance with drug assignments). Monitors can then immediately access site records and comprehensive reports to remotely assess discrepancies, perform root cause analysis, prioritize and plan site visits and prepare timely remediation plans, if necessary.