CRF (Zarni) Reviewer Preut

[Saranath]

CRF (Zarni) Reviewer Preut

https://mu-informatics.org/wp-content/uploads/2023/05/TMHG550_Wk2_ZARNI.pdf

[Zarni Lynn Kyaw]

Arjan do we need to put up our CRF here on our own? I was waiting to review my assign CRF but it is sill not available.

[PREUT ASSAWAWORRARIT]

Followings are some of my suggestion to improve your CRF:
– Date format with first 3 letter of month (such as Apr, Jun) may be used to avoid confusing with DD/MM/YYYY or MM/DD/YYYY.
– Selection of study visit (screening, enrollment, follow-up, and unscheduled) can be replaced by 4 separate case-record form for each visit.
– The past medical history regarding endocrine/metabolic domain should be clarified to prevent confusing of their illness. History of influenza virus infection should address the onset within 6 months. Recall bias of participants can be occurred.
– Some parameter e.g., BMI can be calculated during the analysis in order to minimize workload on data entry.
– Grading of injection reaction appreciated me. The standard of the grading for mild, moderate, and severe should be found out.

Well done,
Thank you.

[Zarni Lynn Kyaw]

Dear Preut,

Thanks for your insightful reply. Great minds do think alike, some of your comments are same as Arjan to improve my CRF.

1) I was trying to choose between EU formant and The Good Clinical and Data Management Practice (GCDMP) and settled on MM-DD-YYYY but you are absolutely right. I will use DD-MM-YYYY from now on.
2) Yes, I will try to be more clear about endocrine domain from now on
3) Yes, it is the same comments from Arjan as well, I will do that next time.
4) Thanks

Sincerely,
Zarni

[Author]

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