Clinical OperationsGlossary Term
ICH E6(R3) Section 5.5
The process of identifying, evaluating, and choosing investigational sites to participate in a clinical trial based on their capability to conduct the study according to the protocol, GCP requirements, and regulatory standards.
Site selection represents a pivotal decision point in clinical trial planning that significantly influences the ultimate success or failure of a study. This process transforms feasibility data into actionable selection decisions, balancing multiple criteria including patient access, investigator qualifications, site infrastructure, regulatory environment, and geographic diversity requirements. The goal is to identify a portfolio of sites collectively capable of enrolling the target population within projected timelines while maintaining quality and compliance.
The selection process evaluates sites across multiple dimensions. Scientific considerations include investigator expertise in the therapeutic area, familiarity with the disease population, and experience with similar trial designs. Operational factors encompass enrollment capacity, adequate staffing, appropriate facilities and equipment, and established regulatory documentation processes. Compliance history from previous trials, including inspection outcomes and audit findings, informs risk assessment. Geographic and demographic considerations ensure the enrolled population represents the intended patient population for the therapy.
Site selection visits provide essential verification of capabilities claimed during feasibility and enable assessment of factors difficult to evaluate remotely. During these visits, sponsor representatives meet with the investigator and study team, tour facilities, review regulatory files from previous studies, and assess the overall environment for trial conduct. The sponsor evaluates whether the site demonstrates genuine commitment to the trial and possesses the infrastructure necessary for success. Final selection decisions integrate all available information to identify sites offering the optimal combination of enrollment potential, quality track record, and operational capability.
Selection visit
"During the site selection visit, the clinical operations team evaluated the pharmacy facilities for investigational product storage, confirmed availability of required imaging equipment, and assessed the research coordinator team depth."
Selection criteria
"Site selection criteria weighted enrollment potential at 40%, quality metrics from prior studies at 30%, and investigator experience at 30%, resulting in selection of 35 sites from among 80 candidates."
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 5.5
The process of identifying, evaluating, and choosing investigational sites to participate in a clinical trial based on their capability to conduct the study according to the protocol, GCP requirements, and regulatory standards.
Site selection represents a pivotal decision point in clinical trial planning that significantly influences the ultimate success or failure of a study. This process transforms feasibility data into actionable selection decisions, balancing multiple criteria including patient access, investigator qualifications, site infrastructure, regulatory environment, and geographic diversity requirements. The goal is to identify a portfolio of sites collectively capable of enrolling the target population within projected timelines while maintaining quality and compliance.
The selection process evaluates sites across multiple dimensions. Scientific considerations include investigator expertise in the therapeutic area, familiarity with the disease population, and experience with similar trial designs. Operational factors encompass enrollment capacity, adequate staffing, appropriate facilities and equipment, and established regulatory documentation processes. Compliance history from previous trials, including inspection outcomes and audit findings, informs risk assessment. Geographic and demographic considerations ensure the enrolled population represents the intended patient population for the therapy.
Site selection visits provide essential verification of capabilities claimed during feasibility and enable assessment of factors difficult to evaluate remotely. During these visits, sponsor representatives meet with the investigator and study team, tour facilities, review regulatory files from previous studies, and assess the overall environment for trial conduct. The sponsor evaluates whether the site demonstrates genuine commitment to the trial and possesses the infrastructure necessary for success. Final selection decisions integrate all available information to identify sites offering the optimal combination of enrollment potential, quality track record, and operational capability.
Selection visit
"During the site selection visit, the clinical operations team evaluated the pharmacy facilities for investigational product storage, confirmed availability of required imaging equipment, and assessed the research coordinator team depth."
Selection criteria
"Site selection criteria weighted enrollment potential at 40%, quality metrics from prior studies at 30%, and investigator experience at 30%, resulting in selection of 35 sites from among 80 candidates."
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.