ICH E6(R3) Section 5.13
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.
Interactive response technology serves as the central nervous system for participant management in modern clinical trials, coordinating the critical functions of randomization, treatment assignment, and drug supply management across often globally distributed sites. Whether accessed through web interfaces or telephone systems, IRT platforms ensure consistent application of randomization algorithms, maintain blinding integrity, and optimize investigational product distribution. The system creates an auditable record of every transaction affecting participant assignment and medication supply.
The randomization function represents the most scientifically critical IRT capability. When a site enrolls an eligible participant, the IRT system applies the protocol-specified randomization algorithm to assign the participant to a treatment arm. The system implements stratification factors when required, maintains balance across treatment groups, and documents the assignment in real time. For blinded studies, the system dispenses medication kit numbers that correspond to assigned treatments without revealing treatment identities, preserving the blind while enabling accurate drug allocation.
Drug supply management through IRT enables just-in-time inventory optimization that reduces waste and prevents stockouts. The system tracks inventory levels at each site, triggers automatic resupply shipments when stock falls below defined thresholds, and ensures that appropriate medication kits are available for each participant based on treatment assignment, visit schedule, and remaining treatment duration. Temperature excursions, expiration dates, and quarantine status can be tracked within the system to prevent dispensing of compromised product.
Participant randomization
"Upon confirming participant eligibility, the coordinator logged into the IWRS, entered the required stratification factors, and received a randomization number along with the medication kit number to dispense for the first treatment period."
Drug resupply
"The IRT system automatically generated a resupply order when site inventory fell below the minimum threshold, ensuring sufficient medication kits would arrive before the next scheduled participant visits."
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 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.
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.
ICH E6(R3) Section 5.13
A computerized system used in clinical trials to manage randomization, treatment allocation, drug supply, and participant status through interactive web-based or telephone interfaces.
Interactive response technology serves as the central nervous system for participant management in modern clinical trials, coordinating the critical functions of randomization, treatment assignment, and drug supply management across often globally distributed sites. Whether accessed through web interfaces or telephone systems, IRT platforms ensure consistent application of randomization algorithms, maintain blinding integrity, and optimize investigational product distribution. The system creates an auditable record of every transaction affecting participant assignment and medication supply.
The randomization function represents the most scientifically critical IRT capability. When a site enrolls an eligible participant, the IRT system applies the protocol-specified randomization algorithm to assign the participant to a treatment arm. The system implements stratification factors when required, maintains balance across treatment groups, and documents the assignment in real time. For blinded studies, the system dispenses medication kit numbers that correspond to assigned treatments without revealing treatment identities, preserving the blind while enabling accurate drug allocation.
Drug supply management through IRT enables just-in-time inventory optimization that reduces waste and prevents stockouts. The system tracks inventory levels at each site, triggers automatic resupply shipments when stock falls below defined thresholds, and ensures that appropriate medication kits are available for each participant based on treatment assignment, visit schedule, and remaining treatment duration. Temperature excursions, expiration dates, and quarantine status can be tracked within the system to prevent dispensing of compromised product.
Participant randomization
"Upon confirming participant eligibility, the coordinator logged into the IWRS, entered the required stratification factors, and received a randomization number along with the medication kit number to dispense for the first treatment period."
Drug resupply
"The IRT system automatically generated a resupply order when site inventory fell below the minimum threshold, ensuring sufficient medication kits would arrive before the next scheduled participant visits."
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 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.
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.