Clinical Trials: Global SOPs (Applicable to all Agencies)

SOP for Data Migration and Archiving of eClinical Systems

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The purpose of this SOP is to define systematic procedures for data migration and archiving of eClinical systems used in clinical trials. It ensures that data is transferred, stored, and retained securely without loss of integrity, guaranteeing compliance with global regulatory standards including ICH GCP, FDA 21 CFR Part 11, EMA, CDSCO, and WHO requirements. This SOP also aims to establish long-term accessibility, auditability, and regulatory inspection readiness.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Privacy/GDPR/HIPAA Alignment in Data Systems

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The purpose of this SOP is to establish processes for ensuring clinical trial data systems comply with Privacy, GDPR (General Data Protection Regulation), and HIPAA (Health Insurance Portability and Accountability Act) requirements. This SOP protects the rights of trial participants, ensures lawful data processing, and maintains global regulatory compliance while safeguarding personal health information (PHI) and personally identifiable information (PII).

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Monitoring Plan Development (RBM Enabled)

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The purpose of this SOP is to define the process for developing a monitoring plan in clinical trials, with emphasis on Risk-Based Monitoring (RBM). The monitoring plan provides a structured approach to ensure subject safety, data integrity, and compliance with regulatory requirements, while optimizing monitoring resources through a risk-based strategy.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Onsite Monitoring Visits and Source Data Verification

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The purpose of this SOP is to define the standardized procedures for conducting onsite monitoring visits and performing Source Data Verification (SDV) in clinical trials. Onsite monitoring ensures participant safety, data integrity, compliance with the protocol, and adherence to ICH GCP, FDA, EMA, CDSCO, and WHO requirements.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Remote/Central Monitoring Procedures

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The purpose of this SOP is to establish standardized procedures for conducting remote and central monitoring of clinical trials. These approaches complement or replace traditional onsite monitoring in specific scenarios, allowing continuous oversight of trial conduct, subject safety, and data integrity while supporting risk-based monitoring (RBM) frameworks.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Risk-Based Monitoring Execution and Documentation

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The purpose of this SOP is to establish procedures for executing and documenting Risk-Based Monitoring (RBM) activities in clinical trials. RBM focuses on prioritizing resources on critical data and processes that affect subject safety and data integrity, ensuring efficiency and compliance with ICH GCP, FDA, EMA, CDSCO, and WHO regulatory requirements.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Monitoring Visit Reports and Communication Timelines

Posted on digi By digi

The purpose of this SOP is to define standardized procedures for preparing, reviewing, approving, and communicating monitoring visit reports (MVRs) in clinical trials. This ensures timely documentation of monitoring findings, effective communication with investigators and sponsors, and compliance with regulatory expectations, thereby safeguarding subject safety and data integrity.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Follow-Up and Closure of Monitoring Findings

Posted on digi By digi

The purpose of this SOP is to describe the standardized process for follow-up and closure of monitoring findings identified during clinical trial monitoring visits. This ensures that deviations, deficiencies, and non-compliance are corrected, preventive actions are taken, and all activities are fully documented for inspection readiness.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Vendor/CRO Oversight and Governance

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The purpose of this SOP is to establish standardized procedures for oversight and governance of vendors and Contract Research Organizations (CROs) engaged in clinical trials. It ensures that all external partners are qualified, contracted, and monitored effectively, and that sponsor accountability under ICH GCP is maintained. The SOP provides guidance on vendor selection, audits, risk assessments, performance monitoring, CAPA management, and documentation for inspection readiness.

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Global SOPs (Applicable to all Agencies), SOP for GCP

SOP for Sponsor Audit Planning and Execution

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The purpose of this SOP is to define the process for planning and executing sponsor audits in clinical trials. Sponsor audits ensure compliance with GCP, protocol requirements, and regulatory standards while verifying that clinical trial processes, vendors, CROs, and investigator sites operate in alignment with contractual and ethical obligations.

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Global SOPs (Applicable to all Agencies), SOP for GCP