Grasping the Concept

Full protocols take time to draft and review. The minutiae of a study’s methodology and/or design often distract teams and delay protocol development. Using a concept protocol makes it easier for all parties to focus on the important points relating to the study. Concept protocols for clinical studies offer an excellent opportunity to capture your study design ideas, stimulate discussion with project teams on the fundamental aspects of a study and provide a means of achieving team alignment before investing the resources required to develop a full protocol. They are short, flexible documents that can be reviewed quickly and edited easily. However, this open and flexible approach can encourage teams to develop multiple drafts. When do you stop? How many drafts should there be? What should you include?

Here you can find advice on identifying your planning and reviewing team and where to get feedback. One shortcoming of concept protocols is that teams can get distracted from their goal by repeatedly working on new drafts. Stay alert for version fatigue, don’t drag out the process.