Main Reason | Examples |
---|---|
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? |