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 Waiting Room: No site staff at this process. No drinking water and snacks.

Volunteers
need to wait at the waiting room, and some of them are complain about this.
 Informed Consent Room (Screening no. allocated): One informed consent room in each
site, and one investigator is here. Normally, each volunteer will be informed about 10-
20minutes.
About subgroup, volunteers need more time to understand.
 Randomization Room: 2 CRCs here. One will operate in IRT system, another one will
check in IRT system and fill in the subject screening and enrollment log.
 Pharmacy Room:1 pharmacist. Will check the vaccine no. outer of the small box
against the drug dispensing log. Once there was an error, which was found by the
vaccinator.
 Vaccination Room:2 site staffs here,
1) vaccinator will confirm the identity of the subject from subject identification code list
(full name, screening no and all) and check the subject no. against drug dispensing log.
2) Reviewer will double confirm the identity of the subject and double check the subject
no. against drug dispensing log.
3) Reviewer will take out the vaccine from the cooler box and check the drug dispensing
log against the small box.
4) Vaccinator will then double check the vaccine no. outer of the small box against of drug
dispensing log.
5) Vaccinator or Reviewer will then fill in the IP injection record.
 Observation Room: 2 site staffs here.

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