Protocol Development

Every clinical investigation begins with the development of a clinical protocol. A research protocol is a document that describes how a clinical trial will be conducted and ensures the safety of the trial subjects and the integrity of the data collected. It describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. According to the ICH Good Clinical Practice guidelines, a protocol should include specific topics that are relevant to the design of the study. Some key sections are as follows:

Please refer to the recommended IRB Tools and Templates. This template provides general guidelines for content during protocol development, however not all sections will be applicable to each type of study design. This process also includes creation of reference tools, subject recruitment and educational materials, case report forms for data capture and other materials that support implementation of the study.

Consultation with a biostatistician is strongly suggested to ensure appropriate data capture to meet the endpoints of the project. Also, consultation with a member of the Trinity Health Office of Research & Innovation – West Michigan is highly recommended during the early stages of protocol development to ensure all content is fully addressed prior to IRB submission. To schedule, please submit a consultation request.