Good work Suppasit👍, here is my suggestions for improving your case record form.
ㅁ Screening
1. This is the part for checking the eligible criteria. So, I think it would be nice to add another question at the end asking whether the subject will be included, temporarily excluded, or excluded, along with the reasons for exclusion.
2. Age: Asking for the subject’s age in exact months they have at the time might be redundant for the subject or the interviewer since they have to calculate for a few seconds. I know it’s just a simple calculation, but I think we can skip the calculation part by letting Excel or the system do the work for you by asking for the month and year of the subject’s birthday instead.
3. Increasing the length of some blank space, especially for the symptoms of influenza illness. Providing more space will ensure that the subject and the interviewer write more details.
4. Asking for the date of completing the CRF and the position of the recorder after the recorder’s name would be nice for auditing and tracking the person who filled in the CRF.
ㅁ Enrollment
1. Adding another question or a blank space to specify the reasons in case the subject did not measure the vital signs. This one will definitely be queried from the data manager back to the staff at the study site since it is required data. So, you will know how to answer this question. Also, it would be nice to record the time of taking vital signs as well.
2. The study is an observer-blind study, so the question asking the type of vaccines should be excluded since the research team does not know which vaccine they injected into the subject. Instead, asking to write down the code on the vial designed to check what type of vaccine the subject received would be better.
3. Adding the question asking for the location site of injection (left or right arm) in case there are AEs or SAEs.
4. Asking the question for the date and time of collecting blood sample.