Process: This assesses the feasibility of the processes that are key to the success of the main study
• Recruitment rates
• Retention rates
• Refusal rates
• Failure/success rates
• (Non)compliance or adherence rates
• eligibility criteria
- Is it obvious who meets and who does not meet the eligibility requirements?
- Are the eligibility criteria sufficient or too restrictive?
• Understanding of study questionnaires or data collection tools:
- Do subjects provide no answer, multiple answers, qualified answers, or unanticipated answers to study questions?
Resources: This deals with assessing time and resource problems that can occur during the main study
• Length of time to fill out all the study forms
• Determining capacity:
- Will the study participants overload your phone lines or overflow your waiting room?
• Determining process time
- How much time does it take to mail out a thousand surveys?
• Is the equipment readily available when and where it is needed?
• What happens when it breaks down or gets stolen?
• Can the software used for capturing data read and understand the data?
• Determining centre willingness and capacity
- Do the centres do what they committed to doing?
- Do investigators have the time to Perform the tasks they committed to doing?
- Are there any capacity issues at each participating centre?
Management: This covers potential human and data management problems
• What are the challenges that participating centres have with managing the study?
• What challenges do study personnel have?
• Is there enough room on the data collection form for all of the data you receive?
• Are there any problems entering data into the computer?
• Can data coming from different sources be matched?
• Were any important data values forgotten about?
• Do data show too much or too little variability?
Scientific: This deals with the assessment of treatment safety, dose, response, effect and variance of the effect
• Is it safe to use the study drug/intervention?
• What is the safe dose level?
• Do patients respond to the drug?
• What is the estimate of the treatment effect?
• What is the estimate of the variance of the treatment effect?