Clinical OperationsGlossary Term
ICH E6(R3) Section 5.14
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
Drug accountability encompasses the comprehensive tracking of investigational product from receipt at the investigational site through final disposition, creating an unbroken chain of documentation that demonstrates what happened to every unit of study medication. This meticulous accounting serves multiple purposes: verifying that participants received assigned treatments as intended, confirming that no product was diverted or misused, supporting assessment of participant compliance, and demonstrating that proper storage and handling procedures were followed throughout.
The drug accountability record documents the complete lifecycle of each medication unit at the site. Receipt records capture shipment details, quantities received, lot numbers, expiration dates, and confirmation that products arrived in acceptable condition. Dispensing records link specific medication units to specific participants and visits, documenting what was provided and when. Return records capture products brought back by participants, enabling calculation of compliance based on remaining medication. Destruction or return-to-depot records document final disposition of unused product.
Accountability reconciliation must demonstrate that all product is accounted for throughout the trial. The fundamental equation requires that quantity received equals quantity dispensed plus quantity remaining plus quantity destroyed or returned, with any discrepancies fully investigated and documented. Monitors verify accountability records during site visits, comparing physical inventory against documented counts and reviewing the chain of documentation for completeness and accuracy. Unresolved accountability discrepancies may indicate serious compliance issues requiring investigation.
Accountability log
"The drug accountability log documented that Kit Number 1025 was received on March 1, stored in the pharmacy refrigerator, dispensed to Subject 003 on March 15, partially returned on April 15 with 10 tablets remaining, and subsequently destroyed per protocol requirements."
Reconciliation discrepancy
"During monitoring, a discrepancy was identified between the accountability log showing 50 remaining tablets and the physical count of 48 tablets, requiring investigation and documentation before the site could receive additional study medication."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.
ICH E6(R3) Section 5.14
The system of documentation and procedures that accounts for all investigational product received at a site, dispensed to participants, returned by participants, and remaining in inventory, ensuring complete traceability throughout the trial.
Drug accountability encompasses the comprehensive tracking of investigational product from receipt at the investigational site through final disposition, creating an unbroken chain of documentation that demonstrates what happened to every unit of study medication. This meticulous accounting serves multiple purposes: verifying that participants received assigned treatments as intended, confirming that no product was diverted or misused, supporting assessment of participant compliance, and demonstrating that proper storage and handling procedures were followed throughout.
The drug accountability record documents the complete lifecycle of each medication unit at the site. Receipt records capture shipment details, quantities received, lot numbers, expiration dates, and confirmation that products arrived in acceptable condition. Dispensing records link specific medication units to specific participants and visits, documenting what was provided and when. Return records capture products brought back by participants, enabling calculation of compliance based on remaining medication. Destruction or return-to-depot records document final disposition of unused product.
Accountability reconciliation must demonstrate that all product is accounted for throughout the trial. The fundamental equation requires that quantity received equals quantity dispensed plus quantity remaining plus quantity destroyed or returned, with any discrepancies fully investigated and documented. Monitors verify accountability records during site visits, comparing physical inventory against documented counts and reviewing the chain of documentation for completeness and accuracy. Unresolved accountability discrepancies may indicate serious compliance issues requiring investigation.
Accountability log
"The drug accountability log documented that Kit Number 1025 was received on March 1, stored in the pharmacy refrigerator, dispensed to Subject 003 on March 15, partially returned on April 15 with 10 tablets remaining, and subsequently destroyed per protocol requirements."
Reconciliation discrepancy
"During monitoring, a discrepancy was identified between the accountability log showing 50 remaining tablets and the physical count of 48 tablets, requiring investigation and documentation before the site could receive additional study medication."
A systematic approach to identifying, investigating, and addressing the root causes of quality problems or non-conformances, implementing corrections to resolve existing issues, and establishing preventive measures to reduce the likelihood of recurrence.
The documented chronological history of the handling, transfer, and storage of investigational products, biological samples, or other controlled materials, establishing accountability at each step from origin to final disposition.
The process of officially registering a qualified participant into a clinical trial after confirming eligibility and obtaining informed consent, marking the point at which the individual becomes a study subject.
A systematic evaluation conducted before trial initiation to determine whether a clinical trial can be successfully conducted at a particular site or in a specific region, considering factors such as patient population, site capabilities, and regulatory environment.
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.