By Laurie Halloran
Protocols serve to protect the people who participate in clinical trials and provide standards so the data collected supports the study’s objectives. When protocols are not followed, it can create serious issues that slow down the study or significantly increase costs. These best practices can help sponsors and CROs work together seamlessly to prevent and alleviate protocol deviations in their clinical studies, keeping development on time and within budget.
The guideline for Good Clinical Practice of the International Council on Harmonization (ICH GCP) defines the protocol as “A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.” Protocols should be written in a clear and concise manner to provide all study personnel with a comprehensive understanding of the disease, the study’s population, and the investigational agent. Consideration must also be given to the burden that will be placed on subjects to participate and investigators to administer with integrity and rigor.