Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to establish standardized procedures for transcribing data from source documents to Case Report Forms (CRFs). Proper transcription ensures data integrity, subject safety, regulatory compliance, and readiness for monitoring, audit, and inspection.
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The purpose of this SOP is to outline the standardized process for managing and resolving data queries raised during clinical trials. Data query management ensures discrepancies between Case Report Forms (CRFs) and source documents are identified, clarified, and corrected to maintain data accuracy, integrity, and regulatory compliance.
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The purpose of this SOP is to define procedures for coding, cleaning, and performing quality checks on clinical trial data. These steps ensure accuracy, consistency, and regulatory compliance, supporting reliable statistical analysis and reporting.
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The purpose of this SOP is to define the process for locking clinical trial databases and managing unblinding in blinded trials. These procedures ensure the integrity of data, protect trial blinding, and guarantee regulatory compliance prior to statistical analysis and reporting.
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The purpose of this SOP is to establish procedures for making corrections to clinical trial documents, managing document versions, and maintaining audit trails. Proper documentation management ensures compliance with data integrity standards, facilitates regulatory inspections, and safeguards trial credibility.
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The purpose of this SOP is to establish standardized procedures for validating computerized systems used in clinical trials. Computerized System Validation (CSV) ensures that electronic systems are fit for purpose, operate consistently, and maintain compliance with regulatory requirements for data integrity, security, and reliability.
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The purpose of this SOP is to establish secure processes for managing access control and user authorization in both paper-based and electronic clinical trial systems. Proper access control ensures data confidentiality, integrity, and accountability, protecting trial data from unauthorized access or alteration.
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The purpose of this SOP is to define the requirements for audit trails and change control in electronic systems (eSystems) used for clinical trial data management. Audit trails ensure transparency and accountability, while change control guarantees that system modifications are authorized, documented, and validated.
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The purpose of this SOP is to define standardized procedures for the use of electronic signatures and identity management in clinical trials. It ensures that signatures applied to trial documents are attributable, authentic, secure, and compliant with international regulatory requirements including FDA 21 CFR Part 11, ICH GCP (E6 R2), EMA computerized system guidelines, CDSCO, and WHO expectations. Proper identity management prevents unauthorized access, ensures accountability, and supports data integrity principles such as ALCOA+.
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The purpose of this SOP is to establish systematic processes for performing data backup and disaster recovery (DR) in clinical trials. It ensures the protection of critical study data, prevents data loss, guarantees business continuity, and safeguards compliance with regulatory requirements such as FDA 21 CFR Part 11, ICH GCP, EMA, CDSCO, and WHO guidance. This SOP aims to maintain integrity, availability, and accessibility of data throughout the trial lifecycle.
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