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Template protocol for clinical trials investigating vaccines--focus on safety elements
Jan Bonhoeffer1, Egeruan B Imoukhuede, Grace Aldrovandi
1University Children's Hospital (UKBB), University of Basel, Basel, Switzerland.
Vaccine
|March 19, 2013
Summary
This guide provides a protocol development template for prophylactic vaccine clinical trials. It ensures safety information is included for regulatory compliance and investigator use across all trial phases.
Area of Science:
- Vaccinology
- Clinical Trial Management
- Regulatory Science
Background:
- Developing protocols for prophylactic vaccine trials requires adherence to regulatory standards.
- Ensuring comprehensive safety information is crucial for trial integrity and participant well-being.
Purpose of the Study:
- To provide a standardized protocol development template for prophylactic vaccine trials.
- To assist investigators and regulatory authorities by including essential safety information.
- To support site strengthening initiatives in clinical research.
Main Methods:
- The document outlines a template for clinical trial protocol development.
- It specifies the inclusion of safety-relevant information for regulatory submission.
- The template is designed for applicability across Phase I-IV prophylactic vaccine trials.
Main Results:
- A comprehensive protocol development guide for vaccine trials is presented.
- The template facilitates the inclusion of critical safety data.
- The guide supports regulatory compliance and investigator-led decision-making.
Conclusions:
- This protocol development template enhances the quality and consistency of prophylactic vaccine trial documentation.
- Adherence to this guide ensures regulatory requirements for safety information are met.
- The document serves as a valuable resource for advancing vaccine research and clinical trial execution.
Keywords:
AEFIAdverse Event Following ImmunizationCIOMSCRFCSPCase Report FormCentral Safety PhysicianClinical trialCouncil for International Organizations of Medical SciencesDSMBData and Safety Monitoring BoardFDAGCPGood Clinical PracticeICFICHIDMCIECIRBImmunizationIndependent Ethics CommitteeInformed Consent FormInstitutional Review BoardInternational Conference on HarmonizationLMICLSMLocal Safety MonitorLow and Middle Income CountryNIHProtocolSAESOPSafetySerious Adverse EventStandard Operation ProcedureThe Independent Data Monitoring CommitteeUnited States Food and Drug AdministrationUnited States National Institutes of HealthVaccineWHOWorld Health Organization
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