CRF (Andrew)

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[TARO KITA]

The form is concise and well organized. Instructions are also clear.
However, “Sex” (related to pregnancy/ lactating) and “Body temperature” (Febrile illness) should be checked/ recorded at the screening level, in accordance with eligibility criteria.

[Andrew Hall]

Thank you Taro! Per your and Dr. Saranath’s feedback, I will make the “Screening” the title of the table, as to include all subsequent questions.

[Pawdoo Paoprapat]

Hi Andrew, it is cleaver way how you created the CRF. Only some minor comments here, Would be better;
– to distinguish inclusion and exclusion criteria out of eligibility criteria
– to run page number
– study name should be indicated on the top of CRF
– physical exam part (HEENT /Cardiovascular /Chest /Abdomen /Musculoskeletal /Neurological /Other body system) seem like open ended questions. it would be helpful to make a choice to select from
normal / abnormal (if abnormal, please specify) this way you can get rid of some open ended fields?

[Andrew Hall]

Pawdoo, thanks for your feedback! I think the normal/abnormal options are a good idea. I intended the bullet point to be a check box. The normal/abnormal/not done options are more specific.

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