The study plan is the foundational document that defines the scope, objectives, design, methodology, and statistical considerations of a GLP-compliant study. According to the OECD GLP Principles, the study plan must be approved by the Study Director and dated before study initiation. It serves as the roadmap for all study activities and as the baseline against which compliance is measured during inspections and audits.
Content Requirements
A GLP-compliant study plan must include a descriptive title, identification of the test and reference items, the name of the sponsor and test facility, and the proposed experimental start and completion dates. It must specify the test system, experimental design, analytical methods, statistical approaches, and records to be maintained. The plan must also identify the Study Director, Principal Investigators for multi-site studies, and other key personnel.
Amendments and Deviations
Any change to the approved study plan must be documented as a study plan amendment and approved by the Study Director before implementation. Deviations from the study plan that occur during study conduct must be recorded, explained, and authorized promptly, with the impact on study integrity assessed. Significant deviations may require formal amendment approval.
Review and Approval Process
The study plan undergoes review by the Quality Assurance Unit (QAU) for GLP compliance before final approval by the Study Director. The sponsor may also review the plan for technical and commercial considerations. All review comments and approval signatures are documented as part of the study record.
Version Control
A robust version control system ensures that only the current approved study plan is in use and that superseded versions are archived. Electronic study plan management systems must comply with 21 CFR Part 11 or equivalent regulations for electronic records and signatures. The audit trail must capture all changes, approvals, and access to the study plan.
Conclusion
A well-constructed study plan is essential for study success, providing clear direction and a compliance baseline for all study activities. Careful planning reduces the likelihood of deviations and ensures that the study will generate data suitable for regulatory submission. The study plan development process should be thorough, collaborative, and fully documented.
