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“headline”: “SOP for Quality by Design/Study Quality Considerations (ICH E8(R1))”,
“description”: “This SOP describes the application of Quality by Design (QbD) principles to clinical trial design and execution, ensuring compliance with ICH E8(R1). It emphasizes risk-based approaches, critical-to-quality factors, and integration of quality management throughout the study lifecycle.”,
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Standard Operating Procedure for Quality by Design/Study Quality Considerations (ICH E8(R1))

Purpose

The purpose of this SOP is to define the process for incorporating Quality by Design (QbD) principles into clinical trial planning, conduct, and oversight. It ensures compliance with ICH E8(R1), focusing on study quality by integrating risk-based approaches and identifying critical-to-quality (CtQ) factors that safeguard participant safety and data reliability.

Scope

This SOP applies to sponsors, CROs, investigators, QA, clinical operations, and regulatory affairs staff involved in clinical trial design, conduct, monitoring, and reporting. It covers protocol design, risk assessment, quality tolerance limits, documentation, and inspection readiness.

Responsibilities

• Sponsor: Defines CtQ factors, oversees QbD integration, and ensures study quality oversight.
• CRO: Implements QbD processes operationally and provides periodic reports to sponsor.
• Investigator: Ensures site-level adherence to QbD principles.
• QA: Conducts audits to verify QbD implementation.
• Clinical Operations: Monitors trial activities against quality tolerance limits.

Accountability

The Sponsor’s Clinical Quality Head is accountable for ensuring adherence to ICH E8(R1) requirements in trial planning and execution.

Procedure

1. Quality by Design Integration
1.1 Identify critical-to-quality (CtQ) factors based on study objectives.
1.2 Incorporate CtQ into protocol and monitoring plans.
1.3 Record in QbD Planning Log (Annexure-1).

2. Risk Assessment and Mitigation
2.1 Conduct structured risk assessment workshops.
2.2 Define risk indicators and mitigation strategies.
2.3 Document in Risk Assessment Log (Annexure-2).

3. Quality Tolerance Limits (QTLs)
3.1 Establish measurable QTLs for critical data points.
3.2 Monitor deviations and escalate as required.
3.3 Record in QTL Monitoring Log (Annexure-3).

4. Oversight and Monitoring
4.1 Ensure ongoing oversight of QbD processes.
4.2 Monitor adherence during site visits and central monitoring.
4.3 Record in Oversight Log (Annexure-4).

5. Documentation and Archiving
5.1 File QbD documentation in TMF and ISF.
5.2 Ensure inspection readiness for regulatory agencies.
5.3 Document archiving in QbD Documentation Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• QbD: Quality by Design
• CtQ: Critical-to-Quality
• ICH: International Council for Harmonisation
• QTL: Quality Tolerance Limits
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. QbD Planning Log (Annexure-1)
2. Risk Assessment Log (Annexure-2)
3. QTL Monitoring Log (Annexure-3)
4. Oversight Log (Annexure-4)
5. QbD Documentation Log (Annexure-5)

References

• ICH E8(R1) – General Considerations for Clinical Studies
• ICH GCP Guidelines
• FDA – Quality by Design in Clinical Development

Version: 1.0

Approval Section

Annexures

Annexure-1: QbD Planning Log

Annexure-2: Risk Assessment Log

Annexure-3: QTL Monitoring Log

Annexure-4: Oversight Log

Annexure-5: QbD Documentation Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for Multi-Regional Clinical Trials (ICH E17)”,
“description”: “This SOP defines the process for conducting multi-regional clinical trials (MRCTs) in compliance with ICH E17 guidelines. It ensures harmonized trial design, operational oversight, and regulatory alignment across multiple geographic regions.”,
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Standard Operating Procedure for Multi-Regional Clinical Trials (ICH E17)

Purpose

The purpose of this SOP is to establish standardized procedures for the design, conduct, and oversight of Multi-Regional Clinical Trials (MRCTs) in accordance with ICH E17 guidelines. MRCTs are critical for generating data acceptable across multiple regions, facilitating simultaneous regulatory submissions, and ensuring diversity and representativeness in study populations.

Scope

This SOP applies to sponsors, CROs, investigators, QA, regulatory affairs, and clinical operations staff involved in MRCT planning and execution. It covers trial design, harmonization of endpoints, regional regulatory alignment, subject recruitment, monitoring, and documentation practices.

Responsibilities

• Sponsor: Ensures global coordination, protocol harmonization, and regulatory strategy alignment.
• CRO: Implements MRCT operations and manages region-specific logistics.
• Investigator: Conducts trial activities in compliance with harmonized protocol.
• QA: Conducts global audits and verifies adherence to MRCT requirements.
• Regulatory Affairs: Coordinates submissions across multiple regions.

Accountability

The Sponsor’s Global Clinical Operations Head is accountable for ensuring MRCT design, execution, and reporting are compliant with ICH E17 and regional requirements.

Procedure

1. MRCT Design
1.1 Incorporate ICH E17 principles into protocol design.
1.2 Define global and regional objectives.
1.3 Record design considerations in MRCT Design Log (Annexure-1).

2. Endpoint Harmonization
2.1 Establish globally relevant and regionally sensitive endpoints.
2.2 Document endpoint harmonization in Endpoint Log (Annexure-2).

3. Regional Regulatory Alignment
3.1 Engage with regulatory authorities in all participating regions.
3.2 Document regulatory interactions in Regional Regulatory Log (Annexure-3).

4. Subject Recruitment and Diversity
4.1 Implement strategies to ensure inclusion of diverse populations.
4.2 Track enrollment data in Recruitment Diversity Log (Annexure-4).

5. Oversight and Monitoring
5.1 Ensure global monitoring consistency across regions.
5.2 Record oversight activities in MRCT Oversight Log (Annexure-5).

6. Data Pooling and Reporting
6.1 Pool data across regions for integrated analysis.
6.2 Ensure regional differences are accounted for.
6.3 Document in MRCT Data Pooling Log (Annexure-6).

Abbreviations

• SOP: Standard Operating Procedure
• MRCT: Multi-Regional Clinical Trial
• ICH: International Council for Harmonisation
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• ISF: Investigator Site File

Documents

1. MRCT Design Log (Annexure-1)
2. Endpoint Log (Annexure-2)
3. Regional Regulatory Log (Annexure-3)
4. Recruitment Diversity Log (Annexure-4)
5. MRCT Oversight Log (Annexure-5)
6. MRCT Data Pooling Log (Annexure-6)

References

• ICH E17 – General Principles for Planning and Design of MRCTs
• ICH GCP Guidelines
• FDA Guidance on MRCTs

Version: 1.0

Approval Section

Annexures

Annexure-1: MRCT Design Log

Annexure-2: Endpoint Log

Annexure-3: Regional Regulatory Log

Annexure-4: Recruitment Diversity Log

Annexure-5: MRCT Oversight Log

Annexure-6: MRCT Data Pooling Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for Safety Data Management across E2A/E2B (ICSRs) and E2F (DSUR) Specifics”,
“description”: “This SOP describes standardized procedures for managing safety data in compliance with ICH E2A, E2B, and E2F guidelines. It ensures accurate collection, validation, reporting, and archiving of ICSRs and DSURs for regulatory submissions and global pharmacovigilance obligations.”,
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Standard Operating Procedure for Safety Data Management across E2A/E2B (ICSRs) and E2F (DSUR) Specifics

Purpose

The purpose of this SOP is to establish a standardized framework for managing safety data in clinical trials in alignment with ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting), E2B(R3) (Electronic Transmission of Individual Case Safety Reports), and E2F (Development Safety Update Report – DSUR) requirements. This ensures accurate and timely adverse event reporting to regulatory authorities, ethics committees, and global PV databases.

Scope

This SOP applies to sponsors, CROs, pharmacovigilance (PV) teams, investigators, QA, and regulatory affairs staff engaged in safety data collection, management, reporting, and archiving. It covers SAE/SUSAR reporting, ICSR preparation and electronic submission, and DSUR compilation and submission.

Responsibilities

• Sponsor: Ensures compliance with ICH E2A/E2B/E2F reporting standards and oversees PV systems.
• CRO: Supports operational aspects of safety data collection and reporting.
• Investigator: Reports SAEs/SUSARs promptly and provides complete safety data.
• PV Department: Prepares, validates, and submits ICSRs and DSURs.
• QA: Audits safety data management processes for compliance with ICH guidelines.

Accountability

The Sponsor’s Pharmacovigilance Head is accountable for compliance with ICH E2A/E2B/E2F requirements and for ensuring data integrity across all safety submissions.

Procedure

1. Safety Data Collection
1.1 Investigators collect SAE/SUSAR data at sites and submit within regulatory timelines.
1.2 Data is entered into the sponsor’s safety database.
1.3 Record in Safety Data Collection Log (Annexure-1).

2. ICSR Preparation (E2A/E2B)
2.1 PV team validates and codes safety data using MedDRA.
2.2 ICSRs are prepared in compliance with ICH E2A definitions.
2.3 ICSRs are transmitted electronically in E2B(R3) format to regulatory authorities.
2.4 Record submission details in ICSR Submission Log (Annexure-2).

3. DSUR Preparation (E2F)
3.1 Prepare annual DSUR covering cumulative safety data.
3.2 Include global safety database analyses, cumulative exposure data, and benefit-risk assessment.
3.3 Submit to regulators, ethics committees, and WHO PV centers as required.
3.4 Document in DSUR Submission Log (Annexure-3).

4. Quality Control
4.1 QA reviews safety reports for completeness and accuracy.
4.2 Discrepancies are documented and resolved.
4.3 Record in Safety QC Log (Annexure-4).

5. Archiving
5.1 Safety data, ICSRs, and DSURs must be archived in TMF and PV databases.
5.2 Archiving is documented in Safety Archiving Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• PV: Pharmacovigilance
• ICH: International Council for Harmonisation
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• ICSR: Individual Case Safety Report
• DSUR: Development Safety Update Report
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• MedDRA: Medical Dictionary for Regulatory Activities

Documents

1. Safety Data Collection Log (Annexure-1)
2. ICSR Submission Log (Annexure-2)
3. DSUR Submission Log (Annexure-3)
4. Safety QC Log (Annexure-4)
5. Safety Archiving Log (Annexure-5)

References

• ICH E2A – Clinical Safety Data Management
• ICH E2B(R3) – Electronic Transmission of ICSRs
• ICH E2F – Development Safety Update Report (DSUR)

Version: 1.0

Approval Section

Annexures

Annexure-1: Safety Data Collection Log

Annexure-2: ICSR Submission Log

Annexure-3: DSUR Submission Log

Annexure-4: Safety QC Log

Annexure-5: Safety Archiving Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for Statistical Principles and Deviations (ICH E9/E9(R1))”,
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Standard Operating Procedure for Statistical Principles and Deviations (ICH E9/E9(R1))

Purpose

The purpose of this SOP is to provide guidance for the application of statistical principles in clinical trials in accordance with ICH E9 and E9(R1). It defines processes for developing statistical analysis plans, handling deviations, applying the estimand framework, and ensuring robust data interpretation that supports regulatory submissions and scientific validity.

Scope

This SOP applies to sponsors, CROs, biostatisticians, investigators, QA staff, and regulatory affairs professionals engaged in statistical planning, monitoring, and reporting of clinical trial data. It covers development of the Statistical Analysis Plan (SAP), handling protocol deviations, and compliance with ICH E9/E9(R1).

Responsibilities

• Sponsor: Oversees statistical compliance with ICH E9/E9(R1) and ensures SAP approval.
• CRO: Executes statistical analyses and ensures timely reporting of deviations.
• Biostatistician: Develops SAP, applies estimand principles, and conducts statistical analyses.
• Investigator: Documents site-level deviations impacting statistical analyses.
• QA: Audits statistical processes for compliance.

Accountability

The Sponsor’s Head of Biostatistics is accountable for ensuring compliance with statistical principles and deviation management in line with ICH E9/E9(R1).

Procedure

1. Statistical Planning
1.1 Develop SAP before database lock.
1.2 Define endpoints, estimands, and statistical methodologies.
1.3 Record in SAP Development Log (Annexure-1).

2. Handling Protocol Deviations
2.1 Identify and classify deviations (major/minor).
2.2 Assess impact on statistical analyses.
2.3 Document in Deviation Impact Log (Annexure-2).

3. Estimand Framework (ICH E9R1)
3.1 Define treatment effect of interest considering intercurrent events.
3.2 Align estimands with trial objectives and endpoints.
3.3 Document in Estimand Framework Log (Annexure-3).

4. Statistical Analysis
4.1 Conduct primary and secondary analyses per SAP.
4.2 Implement sensitivity analyses to account for missing data.
4.3 Document in Analysis Execution Log (Annexure-4).

5. Reporting and Archiving
5.1 Prepare statistical sections of the CSR.
5.2 Archive SAP, deviations, and statistical outputs in TMF.
5.3 Record in Statistical Archiving Log (Annexure-5).

Abbreviations

• SOP: Standard Operating Procedure
• SAP: Statistical Analysis Plan
• ICH: International Council for Harmonisation
• CSR: Clinical Study Report
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• Estimand: A precise description of the treatment effect to be estimated

Documents

1. SAP Development Log (Annexure-1)
2. Deviation Impact Log (Annexure-2)
3. Estimand Framework Log (Annexure-3)
4. Analysis Execution Log (Annexure-4)
5. Statistical Archiving Log (Annexure-5)

References

• ICH E9 – Statistical Principles for Clinical Trials
• ICH E9(R1) – Estimands and Sensitivity Analysis
• ICH GCP Guidelines

Version: 1.0

Approval Section

Annexures

Annexure-1: SAP Development Log

Annexure-2: Deviation Impact Log

Annexure-3: Estimand Framework Log

Annexure-4: Analysis Execution Log

Annexure-5: Statistical Archiving Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for Selective Safety Data Collection (ICH E19)”,
“description”: “This SOP outlines standardized procedures for implementing selective safety data collection in clinical trials in compliance with ICH E19. It defines strategies for optimizing safety data collection while maintaining participant safety and regulatory compliance.”,
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Standard Operating Procedure for Selective Safety Data Collection (ICH E19)

Purpose

The purpose of this SOP is to establish processes for selective safety data collection in clinical trials, in alignment with ICH E19. This approach ensures optimization of safety data collection where comprehensive data are not required, while maintaining subject protection, regulatory compliance, and integrity of safety evaluation.

Scope

This SOP applies to sponsors, CROs, investigators, and pharmacovigilance (PV) teams involved in safety data management in clinical trials. It covers identification of trials eligible for selective data collection, definition of selective data parameters, documentation, and reporting procedures.

Responsibilities

• Sponsor: Defines rationale for selective safety data collection and ensures regulatory approval.
• CRO: Implements selective data collection procedures across sites.
• Investigator: Collects and documents only the predefined safety data points.
• PV Department: Ensures selective data is analyzed and reported appropriately.
• QA: Audits selective safety data processes for compliance with ICH E19.

Accountability

The Sponsor’s Pharmacovigilance Head is accountable for ensuring selective safety data collection aligns with ICH E19 guidance and does not compromise patient safety or trial integrity.

Procedure

1. Identification of Eligible Trials
1.1 Determine trial types suitable for selective safety data collection (e.g., late-phase or pragmatic trials).
1.2 Justify the rationale in trial protocols.
1.3 Document in Trial Eligibility Log (Annexure-1).

2. Defining Selective Safety Parameters
2.1 Define which safety data (AEs, SAEs, concomitant medications) will be collected.
2.2 Obtain regulatory and EC approval.
2.3 Record in Safety Parameters Log (Annexure-2).

3. Investigator Training
3.1 Train investigators and staff on selective safety data collection.
3.2 Document training in Investigator Training Log (Annexure-3).

4. Data Collection and Reporting
4.1 Collect only predefined safety data at site level.
4.2 Record in Selective Safety Data Collection Log (Annexure-4).
4.3 Report aggregated data to sponsor and regulators.

5. Analysis and Oversight
5.1 Analyze collected data for trends and risk signals.
5.2 Escalate unexpected safety concerns to regulators.
5.3 Document in Oversight Log (Annexure-5).

6. Archiving
6.1 Archive selective safety data and related approvals in TMF.
6.2 Record in Safety Archiving Log (Annexure-6).

Abbreviations

• SOP: Standard Operating Procedure
• PV: Pharmacovigilance
• ICH: International Council for Harmonisation
• AE: Adverse Event
• SAE: Serious Adverse Event
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File
• EC: Ethics Committee

Documents

1. Trial Eligibility Log (Annexure-1)
2. Safety Parameters Log (Annexure-2)
3. Investigator Training Log (Annexure-3)
4. Selective Safety Data Collection Log (Annexure-4)
5. Oversight Log (Annexure-5)
6. Safety Archiving Log (Annexure-6)

References

• ICH E19 – Selective Safety Data Collection
• ICH GCP Guidelines
• FDA Guidance on Selective Safety Data Collection

Version: 1.0

Approval Section

Annexures

Annexure-1: Trial Eligibility Log

Annexure-2: Safety Parameters Log

Annexure-3: Investigator Training Log

Annexure-4: Selective Safety Data Collection Log

Annexure-5: Oversight Log

Annexure-6: Safety Archiving Log

Revision History

For more SOPs visit: Pharma SOP

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“headline”: “SOP for QT/QTc (ICH E14) Signal Management”,
“description”: “This SOP describes the procedures for monitoring and managing QT/QTc signals in clinical trials in compliance with ICH E14. It covers ECG monitoring, data collection, signal detection, and regulatory reporting to ensure participant safety and regulatory compliance.”,
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Standard Operating Procedure for QT/QTc (ICH E14) Signal Management

Purpose

The purpose of this SOP is to define processes for managing QT/QTc signals in clinical trials in alignment with ICH E14. QT prolongation poses significant cardiac risks, and proper signal detection and management are essential for ensuring subject safety and meeting regulatory obligations.

Scope

This SOP applies to sponsors, CROs, investigators, pharmacovigilance (PV) staff, data managers, and QA staff engaged in cardiac safety monitoring during clinical trials. It covers ECG data collection, analysis, signal management, regulatory submissions, and archiving.

Responsibilities

• Sponsor: Ensures trial protocols include cardiac safety monitoring per ICH E14.
• CRO: Coordinates ECG collection, transmission, and data management.
• Investigator: Performs ECGs and documents QT/QTc abnormalities.
• PV Department: Monitors for cardiac signals and reports SAEs to regulators.
• QA: Audits ECG and cardiac safety processes for compliance.

Accountability

The Sponsor’s Head of Pharmacovigilance and Biostatistics is accountable for ensuring adherence to ICH E14 cardiac safety requirements and proper QT/QTc signal management.

Procedure

1. ECG Data Collection
1.1 Collect baseline and follow-up ECGs per protocol.
1.2 Use standardized equipment validated for QT/QTc assessment.
1.3 Record in ECG Collection Log (Annexure-1).

2. Data Handling and Analysis
2.1 Transfer ECG data to central lab or validated system.
2.2 Biostatisticians analyze QT/QTc intervals using validated methods.
2.3 Document in ECG Data Handling Log (Annexure-2).

3. Signal Detection
3.1 Identify potential QT prolongation signals (e.g., >450ms in males, >470ms in females).
3.2 Escalate findings to PV and Data Safety Monitoring Board (DSMB).
3.3 Record in Signal Detection Log (Annexure-3).

4. Regulatory Reporting
4.1 Report QT/QTc-related SAEs and SUSARs to regulators.
4.2 Submit safety updates in DSUR and CSR.
4.3 Document in Regulatory Reporting Log (Annexure-4).

5. Risk Mitigation
5.1 Implement dose adjustment, treatment discontinuation, or subject withdrawal as required.
5.2 Ensure subject safety measures are recorded in Risk Mitigation Log (Annexure-5).

6. Archiving
6.1 Archive ECG data, analysis reports, and regulatory submissions in TMF.
6.2 Record archiving details in ECG Archiving Log (Annexure-6).

Abbreviations

• SOP: Standard Operating Procedure
• ECG: Electrocardiogram
• QT/QTc: Corrected QT Interval
• PV: Pharmacovigilance
• SAE: Serious Adverse Event
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• DSMB: Data Safety Monitoring Board
• CSR: Clinical Study Report
• DSUR: Development Safety Update Report
• CRO: Contract Research Organization
• QA: Quality Assurance
• TMF: Trial Master File

Documents

1. ECG Collection Log (Annexure-1)
2. ECG Data Handling Log (Annexure-2)
3. Signal Detection Log (Annexure-3)
4. Regulatory Reporting Log (Annexure-4)
5. Risk Mitigation Log (Annexure-5)
6. ECG Archiving Log (Annexure-6)

References

• ICH E14 – Clinical Evaluation of QT/QTc Interval Prolongation
• ICH GCP Guidelines
• FDA Guidance – Clinical Evaluation of QT/QTc Interval Prolongation

Version: 1.0

Approval Section

Annexures

Annexure-1: ECG Collection Log

Annexure-2: ECG Data Handling Log

Annexure-3: Signal Detection Log

Annexure-4: Regulatory Reporting Log

Annexure-5: Risk Mitigation Log

Annexure-6: ECG Archiving Log

Revision History

For more SOPs visit: Pharma SOP