What is Kit Management?

Kit Management is the process of tracking and managing individual investigational product kits throughout a clinical trial. It involves assigning unique kit identifiers, monitoring kit status, and ensuring that the correct kits are dispensed, returned, replaced, or reconciled according to the study protocol.

Kit Management is used throughout a clinical trial to maintain accurate tracking of investigational product kits from depot to study site and ultimately to participants. It helps study teams monitor kit availability, expiration dates, dispensing history, returns, and replacements while maintaining complete traceability.

Effective kit management supports participant safety, inventory accuracy, and regulatory compliance by ensuring that each kit can be tracked throughout its lifecycle.

Clinion RTSM enables study teams to configure kit types, kit numbering, dispensing rules, replacement strategies, and expiry management during study setup. As participants are randomized and treated, the system automatically assigns eligible kits based on the protocol-defined dispensing rules and maintains complete traceability of every kit throughout the study.

The platform also supports kit replacement, returns, reconciliation, expiry tracking, and inventory updates across study sites, helping maintain accurate drug accountability and operational efficiency.

A participant is randomized to receive the investigational treatment during a scheduled study visit. Based on the predefined dispensing rules, the RTSM system assigns an available drug kit with the appropriate treatment allocation and records the kit number in the participant's study record. If the kit expires or is damaged before dispensing, the system assigns a replacement kit while maintaining a complete audit trail of both kits.

Drug Supply Management

Drug Dispensing

Investigational Medicinal Product (IMP)

Inventory Management

Randomization

Drug Accountability

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