CRF (Sittidech) Reviewer Khaing Zin Zin Htwe

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[Khaing Zin Zin Htwe]

It is a very well done CRF with neat design. I like how month is recorded so that it cannot be misread as day. Having investigator’s signature space, instruction for filling out physical examination, degree of severity of solicited reactions included and being able to choose which visit in solicited reactions page are what I find significantly good in this CRF design.
Eligibility criteria questions are easy to understand for investigator, however, most of them can be written shorter in my opinion. As for adding 2 identifiers (screening no. and participant no.), I get the point that some subjects might be screened but not enrolled because of ineligibility. But, I think only 1 identifier might do the work since unenrolled subjects might not be entered into the database. Other small findings are:
– QIV and TIV for vaccination arm (instead of right and left)
– 3 boxes for age (only 2 required)
– unit for respiratory rate being bpm
– being not sure if we can match solicited symptoms on AE page as you mentioned because all of the AEs might not be written in the AE page.

[Sittidech Surasri]

Thank you very much for your comments. I do agree with all of them. For the solicited symptoms, I think we can design separately or put on the same page. Happy New Year and be safe.

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