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Clinical study statistics

A comprehensive set of Study Insights dashboards provides statistical charts and visual representation for all your studies and their various aspects, helping you analyze and track the dynamics and specifics of your investigational processes.

The Clinical Study category of dashboard charts is dedicated to two major statistical analysis tools:

In this section:

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

A process of ensuring data accuracy and integrity within a clinical trial. SDV involves the review and comparison of data recorded in the source documents against the data captured on the case report forms (CRFs). During SDV, a trained monitor or clinical research associate (CRA) compares the source data to the CRFs to identify any discrepancies or errors. They may review laboratory results, medical history, adverse event records, and other relevant information. Discrepancies found during SDV are usually documented and resolved through data clarification or query processes with the site personnel responsible for data collection.

A process of ensuring data accuracy and integrity within a clinical trial. SDR refers to a broad assessment and review of the source data beyond a simple verification process. It involves a comprehensive review of the collected subject data to evaluate its quality, consistency, and compliance with the study protocol, standard operating procedure, and regulatory requirements. During SDR, the clinical research associate (CRA) or data manager (DM) examines the data for completeness, accuracy, and compliance with the established criteria. They analyze trends, perform data reconciliations, and identify any potential anomalies or issues that may require further investigation or data clarification.

A set of numbers that are the high and low ends of the range in laboratory test results considered normal for a certain group of subjects and against which the actual results are measured and considered abnormal.

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion criteria, failing to perform a required lab test, and so on.

An activity in which a monitor, usually a clinical research associate (CRA), visits sites to review and verify study-related activities, including data collection, patient safety, and adherence to the study protocol. The monitor also verifies that the study complies with relevant regulatory requirements and GCP guidelines.