CRF (Auswin) Reviewer Kamonporn

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[Sittidech Surasri]

Dear Auswin,

You did a great job and cover all requirements. I have reviewed your CRF and kindly find my comments as below;

1. Date: the format to enter the data is good but you can specify the format like “dd-MMM-YYYY instead of (ex. 30 – JAN – 2020)
2. Time: the format to enter the data is good but you can specify the format like ” HH:MM in 24 Hrs format instead of (ex. 23.30)

3. Age: it is redundant where you have created both at the screening and enrollment visit
4. Laboratory: Should add the check box for not done for HAI titer;
24. A/H1N1 Antibody titer 1 : ………………..
25. A/H3N2 Antibody titer 1 : ………………..
26. B/Yamagata Antibody titer 1 : ………………..
5. SOLICITED REACTION; It would be better to add the level of severity such as mind, moderate, severe including the date of symptom is occurred and ended.
6. The summary of eligibility check should be add on the eligibility section.

[Auswin Rojanasumapong]

Thank you for your comment. It is very helpful for me to develop better CRFs.

[Kamonporn Suwanthaweemeesuk]

It was easy to read with complete information as given. There was some information that need to be in detailed more such as severity of reaction.

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