Preparatory to Study Initiation
Once you have your study design and cohort determine for your study you can start writing you actual protocol and preparing other documents that are needed from a legal and business perspective, as well as, developed recruiting, consenting, monitoring and data management plans that will take place during study execution.
Protocol Development
When conducting clinical research with an industry sponsor or partner, a clinical trial protocol will be provided to you. However, in some cases, you may decide to write your own protocol and serve as the PI and sponsor of a study. These are called investigator-initiated studies. There are several protocol templates to help you if you choose to write your own protocol: