Hoofdstudieprotocol

Hoofdstudieprotocol is a central document in research projects, especially clinical trials, that describes the purpose, design, and planned methods for the main study. The term is used in Dutch-language contexts to refer to the primary protocol that governs the conduct of the study. The protocol outlines the study objectives, background, hypotheses, study design (for example randomized controlled trial or observational cohort), eligibility criteria, interventions, comparators, outcomes, and endpoints, as well as the statistical analysis plan. It also covers recruitment and consent procedures, data collection methods, schedule of visits, data management, quality control, adverse event reporting, safety monitoring, stopping rules, and dissemination plans. The document serves as the blueprint for trial conduct and is the basis for ethical review, regulatory submission, and funding applications.

In practice, the hoofdstudieprotocol is drafted at the study outset and undergoes review by ethics committees or institutional review boards. It must comply with relevant regulations and guidelines, such as Good Clinical Practice, data protection laws, and trial registration requirements. Protocol amendments are used to update the document when changes occur, and new versions are timestamped and approved by the appropriate authorities. The protocol is typically accompanied by related documents like the informed consent form, patient information sheet, data management plan, and statistical analysis plan, and is separate from patient-facing materials. The hoofdstudieprotocol thus anchors study design, governance, and accountability.