Development and validation of observational and qualitative study protocol reporting checklists for novice researchers (ObsQual checklist)

Currently, no reporting guidelines exist for observational and qualitative study protocols. In an effort to enhance the quality of research protocols, we introduce two study protocol reporting checklists that we have developed. These checklists include educational components and examples intended to assist novice researchers. Through the analysis of 333 study protocols submitted for ethical review, our checklists have been developed and validated, demonstrating their applicability across various observational and qualitative study designs. We provide insights into the systematic implementation of these checklists alongside complementary elements that support their effectiveness. We recommend longitudinal monitoring and evaluation of checklist utilization.