Drug Accountability

Drug accountability in clinical research refers to the appropriate receipt, storage, dispensing, use, return and final disposition of investigational products throughout a clinical trial.

Effective accountability helps ensure that investigational products are used according to the approved protocol, their integrity is maintained, participant safety is protected and a traceable record of product movement and use is available.

Responsibility for Drug Accountability

Responsibility for investigational product accountability at the investigator site rests with the investigator/institution.

The investigator/institution may assign some or all accountability activities to an appropriately qualified pharmacist or another individual. When activities are assigned, they should remain under the supervision of the investigator/institution.

The sponsor is responsible for supplying investigational products and for establishing appropriate arrangements and instructions for their handling and storage.

Current requirements for investigational product management are described in the ICH E6 Good Clinical Practice guideline.

Receipt and Inventory

Investigational products received at the investigator site should be appropriately documented.

Accountability records should enable the site to track relevant information such as:

• Date and quantity received
• Inventory at the site
• Batch or serial numbers
• Expiration dates, where applicable
• Unique product codes, where applicable
• Dispensing or use by individual participants
• Products returned by participants
• Products returned to the sponsor or otherwise disposed of

Records should provide sufficient traceability to account for investigational products throughout the trial.

Storage of Investigational Products

Investigational products should be stored according to the conditions specified by the sponsor and applicable regulatory requirements.

Appropriate storage controls may include temperature monitoring, restricted access and other measures necessary to maintain product integrity and security.

Storage excursions or other significant issues should be documented, evaluated and managed according to applicable procedures.

Dispensing and Use

Investigational products should be used only in accordance with the approved clinical trial protocol.

Where applicable, the investigator or appropriately designated personnel should explain correct product use to participants and check at intervals appropriate for the trial whether participants are following the instructions properly.

Dispensing and participant-specific use should be appropriately documented to maintain accountability and traceability.

Investigational Product Returns

Unused investigational products may need to be retrieved from participants and appropriately accounted for.

Products returned by participants should be documented according to trial procedures so that quantities dispensed, used and returned can be reconciled where applicable.

Unused investigational products may subsequently be returned to the sponsor or handled through another authorised disposition process.

Final Disposition or Destruction

Unused investigational products should be returned to the sponsor or undergo an alternative disposition when authorised by the sponsor and permitted under applicable regulatory requirements.

Destruction or other final disposition should be appropriately controlled and documented.

Investigational products should not be destroyed or otherwise disposed of outside the authorised trial procedures.

Investigational Product Reconciliation

Accountability records should allow investigational product quantities to be reconciled throughout the clinical trial.

Reconciliation may compare quantities received, available in inventory, dispensed or administered, returned and finally disposed of.

Unexplained discrepancies should be investigated and appropriately documented.

Sponsor Responsibilities

The sponsor should ensure that appropriate instructions are available concerning investigational product receipt, handling, storage, dispensing, retrieval, return and authorised alternative disposition.

The sponsor should also implement safeguards designed to support product integrity, use according to the protocol and participant safety.

The specific approach to investigational product management may vary according to factors such as the product characteristics, route and complexity of administration and existing knowledge of its safety profile.

Monitoring Drug Accountability

Drug accountability is commonly reviewed as part of clinical trial monitoring.

Monitoring may evaluate whether investigational products are being appropriately stored, dispensed, documented and reconciled and whether significant discrepancies or deviations have been appropriately addressed.

The extent of monitoring should be proportionate to the characteristics and identified risks of the clinical trial.

For more information on how investigational product accountability fits within broader site oversight, see Routine Site Monitoring.

Importance of Drug Accountability

Drug accountability provides traceability for investigational products from receipt through use and final disposition.

Accurate accountability records, appropriate storage and controlled dispensing help protect participants, maintain investigational product integrity and demonstrate compliance with the clinical trial protocol and applicable requirements.

Drug accountability should therefore be maintained throughout the trial as an ongoing responsibility rather than addressed only during monitoring visits or study close-out.

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