- This topic has 2 replies, 3 voices, and was last updated 3 years, 8 months ago by
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You did a great job. Kindly find my comments as below which I think that it should be added for these two visits of the CRF:
1. Site ID or Group should be add on the subject ID e.g., 1-001.
2. Date of visit was missing.
3. Date of consent was missing.
4. Demographic data should be added such as DOB, Age, Sex and Race.
5. Physical examination was missing such as Height, weight, blood pressure, heart rate, respiratory rate, body temperature.
6. The [ ] check box for body temperature was missing (if you could specify the decimal would be perfect)
7. Pregnancy test should have check box [ ] for not done (ND.
8. Should have the question to check/summarize that Is the participant eligible to take part in this study?
9. Date of blood collection and time was missing.
10. The check box for HAI result should add more boxes 1:[ ][ ][ ][ ] or the check box should be bigger because the titer could be up to 1024, and should have check box for not done (ND).
11. Date and time of vaccination was missing.
12. The reactions (local/systemic) should be the checkbox for each reaction to avoid the quality of hand writing.
13. AE/SAE should be added. -
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