CRF (Sri Budi Fajariyani)

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[Karina Dian Lestari]

Hi Fajar,

The CRF layout is clear and conscience. The date and time format are clearly stated, and appropriate units are provided. It is nice to put the “not measured” checkbox to clear the confusion about whether the data is not entered or not done. I also like the idea to put the method of temperature check and blood pressure measurement. However, there are several things that are missing and could be improved in the CRF:

• Screening ID and Subject ID are required and should be recorded since not all participants are eligible to enrol (for example if we screened pregnant women).
• There is no Subject ID field on every page of CRF. This is important so we can know which participant this CRF belong to.
• There is no checkbox that clearly stated whether the subject is eligible for enrolment.
• There is no demographic section or any field provided to record age, year of birth, sex, and race.
• There is no laboratory section or any field provided to record the urine pregnancy test (for screening visit), and antibody titer sample (for enrolment visit, before vaccination).
• In the vaccination section, we do not know which vaccine for which subject since it is an observer-blinded trial. We should put vaccination date and time, and vaccination arm in this section.

[Anawat ratchatorn]

Overall CRF is very clear and easy to use. There are some suggestion from me.
1. It would be good to create box or space in many field that should be filled in numeric such as BP, HR. To be more clearer
2. Physical Examination should be more comprehensive not too narrow and too specific.

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