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9/26/2006
For the dose of drug in section 3c- do they want mg/kg, mLs, etc?
For both 027 and 046, list the dose in mL. The RCC, if they want, will look up any conversions in the protocol document. They want the EAE report to be kept simple and clear.
9/26/2006
On page 3, for those babies who may die before getting dosed with any study product and we have to report this, can we tick NA next to section 4 even though it is designed to be used to indicate that the study agent is a vaccine or do we have to fill out section 4 (and dose above from section 3) and just write none or N/A or leave blank for the majority of questions on dosing?
Whether a baby receives a dose of study product or not, section 3 is to be completed.
Check N/A in section 4.
In section 5, complete action taken with study agent as “O”. This signifies that the baby was not on study agent at the time of death.
Make a note that the infant never received a dose of study agent in the narrative section.
9/26/2006
We would like to call the reporter name something like 027 SAE/EAE office, with a group email etc. Is this possible?
No, this is not possible. The reporter needs to have a person’s name that matches the email address given. The RCC does not want any group email names. If the person named is not available, then the RCC will be glad to talk to anyone who has knowledge of the particular case. They just want a contact name.
9/26/2006
So our interpretation of [EAE]"reporter" is not the person who saw the patient initially and completed the source docs, but the person who did the actual report. Is this a correct interpretation?
Yes, that is correct.
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