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Discussing the study protocol (Part 1)
“THE MONSTER”
The study protocol within the clinical research environment is often seen as a “monster” ; a detailed intensive document which is frequently read once and discarded.People often don’t come back to it!
It is worth while dissecting the monster and creating quick reference tools such as tables and flowdiagrams based on the information contained within the protocol, such tools can then be used on a daily basis by members of the study team who feel overwhelmed by the protocol. When reviewing the study protocol think about your role within the study and focus on “what is relevant to you”.
DOCUMENTATION
Aim to keep documentation aside from the protocol such as study management plans etc to a minimum if possible as these create room for error. Use standard operating procedures to guide training activities around the protocol, a SOP around training when a study ammendment is made should exist; encourage staff to communicate and engage in discussions about their training. Have an awareness that more documentation creates more challenges.
SAMPLE SIZE
It is worth discussing how the sample size was calculated ; as it serves to highlight the challenges around recruitment and starts the process of identifying, barriers, methods, systems, and processes which will allow a study team to constantly assess recruitment. Remember to include review processes into your protocol ; allows for a pragmatic approach to the study.
OUTCOME
The outcome of death, can be looked at as a 1 & 0, where 1 is a person who is living and 0 is a person who is dead – the state of dead is not dynamic. However, the outcome of death as it relates to a IMP will vary and needs to be ojectively assessed; by an independent 3rd party.