Clinical OperationsGlossary Term
ICH E6(R3) Section 4.3
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.
Enrollment represents the transition from candidate to participant, the formal point at which an individual who has completed screening, met all eligibility criteria, and provided informed consent becomes an active subject in the clinical trial. This milestone triggers regulatory counting for enrollment targets and initiates the participant's involvement in study procedures. The enrollment process must be executed precisely, with clear documentation demonstrating that all prerequisites were satisfied before enrollment occurred.
The sequence of enrollment activities is critical for regulatory compliance. Informed consent must be obtained before any screening procedures are performed, and eligibility must be confirmed before randomization or treatment assignment. Documentation must demonstrate that consent preceded screening, that all required screening assessments were completed, that each eligibility criterion was evaluated and met, and that the enrollment date reflects when all requirements were satisfied. Any deviation from this sequence may constitute a protocol violation with potential implications for data integrity.
Enrollment metrics drive critical operational decisions throughout trial conduct. Sponsors track enrollment against projections to identify sites falling behind expectations and assess whether overall timelines are achievable. Enrollment curve analysis reveals whether recruitment activities are producing desired results and whether adjustments are needed. Competitive enrollment information indicates how the study compares to similar trials in the therapeutic area. These metrics inform decisions about adding sites, extending enrollment periods, or implementing additional recruitment strategies.
Enrollment confirmation
"After verifying that all screening laboratory results were within acceptable ranges and the participant met all inclusion criteria with no exclusions, the coordinator completed enrollment in the IWRS system and obtained the randomization assignment."
Enrollment tracking
"The weekly enrollment report showed the study at 67% of target with four months remaining, prompting the operations team to implement enhanced recruitment at underperforming sites and consider adding new sites."
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.
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 4.3
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.
Enrollment represents the transition from candidate to participant, the formal point at which an individual who has completed screening, met all eligibility criteria, and provided informed consent becomes an active subject in the clinical trial. This milestone triggers regulatory counting for enrollment targets and initiates the participant's involvement in study procedures. The enrollment process must be executed precisely, with clear documentation demonstrating that all prerequisites were satisfied before enrollment occurred.
The sequence of enrollment activities is critical for regulatory compliance. Informed consent must be obtained before any screening procedures are performed, and eligibility must be confirmed before randomization or treatment assignment. Documentation must demonstrate that consent preceded screening, that all required screening assessments were completed, that each eligibility criterion was evaluated and met, and that the enrollment date reflects when all requirements were satisfied. Any deviation from this sequence may constitute a protocol violation with potential implications for data integrity.
Enrollment metrics drive critical operational decisions throughout trial conduct. Sponsors track enrollment against projections to identify sites falling behind expectations and assess whether overall timelines are achievable. Enrollment curve analysis reveals whether recruitment activities are producing desired results and whether adjustments are needed. Competitive enrollment information indicates how the study compares to similar trials in the therapeutic area. These metrics inform decisions about adding sites, extending enrollment periods, or implementing additional recruitment strategies.
Enrollment confirmation
"After verifying that all screening laboratory results were within acceptable ranges and the participant met all inclusion criteria with no exclusions, the coordinator completed enrollment in the IWRS system and obtained the randomization assignment."
Enrollment tracking
"The weekly enrollment report showed the study at 67% of target with four months remaining, prompting the operations team to implement enhanced recruitment at underperforming sites and consider adding new sites."
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.
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.