Trusted Resource for Clinical Trials, Protocols & Progress
A Case Report Form (CRF) is a standardized document used by clinical trial investigators to collect protocol-specific data from each subject. The data recorded in the CRF is the foundation for clinical trial analysis, submission, and regulatory review. According to USFDA guidelines, CRFs must accurately represent source data, be protocol-aligned, and support verification and audit processes.
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Data cleaning involves identifying missing, inconsistent, or erroneous data within Case Report Forms (CRFs) and other study databases. The process ensures that data is complete, accurate, and ready for analysis or submission to regulatory agencies like the USFDA.
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Source Data Verification is the process by which monitors (typically Clinical Research Associates or CRAs) compare the data entered into the trial database with the source documentation (e.g., patient charts, lab reports, hospital records) to confirm accuracy, completeness, and protocol adherence. As per USFDA and ICH GCP guidelines, SDV is a required part of clinical trial oversight.
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Clinical trial data must be reliable, consistent, and verifiable. Regulatory authorities like the USFDA mandate Good Clinical Practice (GCP) standards, which require that trial data reflect original observations and are recorded promptly and accurately. Data errors, even minor ones, can compromise subject safety, lead to delays in drug approval, or trigger regulatory penalties.
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EDC (Electronic Data Capture) systems are software platforms that allow clinical trial sites to enter data directly into electronic Case Report Forms (eCRFs) via web-based portals. This eliminates the need for paper CRFs, speeds up data availability, and enhances monitoring efficiency. Leading EDC systems include Medidata Rave, Oracle InForm, and Veeva Vault EDC.
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An audit trail is a chronological, secure, and tamper-evident log that tracks all changes made to clinical trial data, including what was changed, who made the change, when it was changed, and why. Audit trails are a regulatory requirement for electronic records under 21 CFR Part 11 and are essential for data validation and inspection readiness.
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Clinical data managers (CDMs) are responsible for overseeing the lifecycle of data collected in a clinical trial. Their primary objective is to ensure that data is reliable, complete, and ready for statistical analysis and regulatory submission. In multinational studies, this role expands to include harmonizing data collection processes across regions and adapting to varying regulatory requirements.
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A query is a request for clarification or correction of data captured in a Case Report Form (CRF). It may arise due to missing, inconsistent, out-of-range, or illogical data entries. Queries are essential for maintaining GMP-compliant data integrity and ensuring that the final database supports valid clinical conclusions.
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A protocol deviation is any instance in which the study conduct diverges from the approved protocol. Deviations may be intentional or unintentional, minor or major, and must be logged and reported appropriately to maintain GMP compliance and Good Clinical Practice (GCP) standards.
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An audit typically evaluates:
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