CRF (TARO)

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[Sri Budi Fajariyan]

The CRF is good and concise, may need to add an informed consent form and inclusion and exclusion criteria

[Kansiri Apinantanakul]

The overall eCRF is clean and concise. The layout and format are straightforward to follow. The data entry note, for example (DD/MMM/YYYY), it could help the data entry personnel to get enter the data correctly.
For improvement gap,
1. We could add the study vaccine kit number. In my opinion, this could be beneficial in statistical analysis that analyst the difference between treatment group
2. Post injection reaction: we could add the specified reaction type mentioned in the protocol (pain, redness, swelling, 
induration, and ecchymosis) the ensure that all reaction was monitored and recorded appropriately
3. We recorded many AE that might not have the same onset and end date. We could design the Start and End Time of the reaction specifically for each reaction

Feel free to discuss with me if I misunderstood your design
Thank you !

[TARO KITA]

Thanks for the valuable inputs! I overlooked all the points you raised. In particular, “study vaccine kit number”, although vaccine trial is not my area of expertise, it will contribute to a detailed analysis.

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