Who is responsible for drug accountability in clinical trials?

Drug Accountability of the Investigation Medication begins from the selection of location for its storage. Issues with drug accountability are major and the majority of warning letters from regulators are a result of this. Major delays are faced by sites for non-conformity and it often leads to non-acceptance of trial data. Drug accountability is of utmost importance and it is the clinical investigator who remains responsible for the entire process taking place at the clinical site. If the supplies are controlled substances then more attention shall be needed from the Investigator in terms of its storage and disposition. IRT systems allow in streamlining such processes by keeping a single source of data and hence the process of Drug Accountability tracking becomes easier.

It is the complexity surrounding the paper-based systems that makes them more prone to errors. Drug accountability shall be maintained at sponsor level and site level. The Investigational medication documented as shipped should reconcile with the documentation of used and unused. The Drug Accountability at site begins once an investigational drug reaches the site. Records need to be maintained and staffs need to confirm that the contents that have been shipped match its previous record. The authorized person needs to put his signature with date after thorough verification. Once these have been completed, the investigational drug needs to be stored securely maintaining the standards specified in the protocol. Entire details need to be updated in the drug accountability log and with the commencement of trials; drug dispensing records are to be updated in writing in multiple documents. Site shall maintain all the data of the drugs right from drug dispensing to final disposition. Paper-based drug accountability never ends with the end of study, discrepancies in accountability logs need to be resolved, and its copies are to be returned with the original shipment records. The sponsor should receive the reconciled log along with the returned investigational drugs. Any discrepancy in drug accountability not only violates the regulations but also points the integrity of the study and public health.

Utilizing electronic medium for data collection and tracking helps in mitigating the challenges associated with data accountability. When data associated with a trial gets centralized, then the visibility gets doubly enhanced and a single accountable system improves the process of reporting. This entire method eases regulatory compliance achievement process and accountability audit issues get resolved immediately. As the use of the IRT system increases the pace, end-of-study documents are prepared in no time using the single system as the source.

mIRT has a special feature to track Drug Accountability where the reconciliation of the supplies that are used, lost, damaged and returned shall be captured which enables the system to calculate the compliance of the drug automatically.

With the current advancements, as the world is moving ahead and accepting technology, there is an increased level of visibility in the supply chain for both the regulators and sponsors.