Guidelines for Pharmacovigilance Investigator Initiated Studies (IIS)
1) Purpose
The purpose of this SOP is to establish procedures for the management and pharmacovigilance oversight of Investigator Initiated Studies (IIS) conducted by external investigators.
2) Scope
This SOP applies to all pharmacovigilance personnel responsible for reviewing, monitoring, and reporting adverse events associated with Investigator Initiated Studies (IIS).
3) Responsibilities
The Pharmacovigilance (PV) Manager is responsible for overseeing the pharmacovigilance activities related to IIS. Investigators and study sponsors are responsible for conducting studies in compliance with this SOP and applicable regulations.
4) Procedure
4.1 Study Proposal Review
- Review and evaluate proposals for Investigator Initiated Studies (IIS) to assess scientific merit, feasibility, and potential risks.
- Ensure that proposed studies align with the objectives of pharmacovigilance and comply with regulatory requirements.
4.2 Pharmacovigilance Plan Development
- Develop a pharmacovigilance plan specific to each IIS, outlining procedures for adverse event reporting, monitoring, and risk management.
- Specify roles and responsibilities for pharmacovigilance activities, including data collection, reporting timelines, and communication channels.
4.3 Adverse Event Reporting
- Educate investigators and study personnel on the identification, documentation, and reporting of adverse events associated with the IIS.
- Establish procedures for collecting and documenting adverse event data, including severity assessments and causal relationships.
- Ensure timely reporting of adverse events to the PV team and regulatory authorities as required by applicable regulations.
4.4 Safety Monitoring and Signal Detection
- Implement mechanisms for ongoing safety monitoring and signal detection throughout the duration of the IIS.
- Conduct regular reviews of safety data to identify potential safety signals or emerging risks associated with the study.
4.5 Data Analysis and Reporting
- Analyze adverse event data collected from the IIS to assess trends, patterns, and potential safety concerns.
- Prepare periodic safety reports summarizing adverse event data, study progress, and any safety-related findings.
4.6 Compliance and Quality Assurance
- Ensure that all pharmacovigilance activities related to the IIS comply with this SOP, relevant regulations, and ethical standards.
- Conduct internal audits or reviews to assess compliance with pharmacovigilance requirements and identify areas for improvement.
4.7 Communication and Collaboration
- Establish channels for effective communication between the PV team, investigators, study sponsors, and regulatory authorities regarding pharmacovigilance matters.
- Collaborate with investigators and study sponsors to address pharmacovigilance issues, implement risk mitigation strategies, and ensure patient safety.
4.8 Documentation and Record Keeping
- Maintain accurate and complete records of pharmacovigilance activities related to each IIS, including protocols, adverse event reports, correspondence, and safety assessments.
- Ensure that all documentation is stored securely and is readily accessible for inspection and review.
4.9 Training and Awareness
- Provide training to investigators and study personnel on pharmacovigilance requirements, procedures, and their roles in ensuring patient safety during the IIS.
- Offer continuous education and updates on pharmacovigilance practices and regulatory changes affecting IIS.
4.10 Continuous Improvement
- Regularly evaluate and update the pharmacovigilance procedures and plans for IIS based on feedback, audit findings, and evolving regulatory requirements.
- Implement improvements to enhance the efficiency, effectiveness, and quality of pharmacovigilance oversight for IIS.
5) Abbreviations, if any
PV – Pharmacovigilance, SOP – Standard Operating Procedure, IIS – Investigator Initiated Study
6) Documents, if any
Study protocols, pharmacovigilance plans, adverse event reports, safety monitoring reports, training materials.
7) Reference, if any
ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Investigator-Initiated Investigational New Drug (IND) Applications, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VIII – Post-Authorisation Safety Studies (PASS).
8) SOP Version
Version 1.0
