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I like the format. It is clear and easy to read. Also, I think it is a good point whether female participants are on birth control before we will provide birth control measure to them.
I have no experience on clinical data and designing CRF. I just would like to ask or share an idea.
– In the exclusion criteria, I am wondering whether it is possible that a participant would not remember their own vaccination history or their illness that is alike influenza? I think here we may need a choice of not certain.
-The screening page and enrollment page will not be bound together, right? I guess from the page number. I hope there is a log book for recoding the subject ID and subject randomisation number. And why don’t you also use subject ID in page of enrollment?
-It is randomised observed-blinded study. I am not sure that the type of groups can be recorded here or in a log book.
-Also, from the protocol this study does not vary the volume of the vaccine. So, I am not certain that we need to record here.
-Is it possible that the HAI titers can go up to 1:100 or more? If so, that means you may need more box(es).
-I think the same as Sri, you may need vital sign and medical history sections.
-Is ‘randomisation group’ and ‘type of vaccine administered’ repeated each other?
-No anatomical location where the participant got the vaccine recorded. -
Thank you for your comments and suggestion
It could help me improve a lot. !
In fact, I’m not quite sure whether my design is suitable or not.
Please see my idea belowIn the exclusion criteria (If the patient cannot remember the vaccine history)
In my opinion, if the patient cannot remember their history, It might automatically fall into excluded group . However, adding the not certain is a good idea as well, we might capture some trends from this.-The screening page and enrollment page will not be bound together, right? I guess from the page number.
I hope there is a log book for recording the subject ID and subject randomization number. And why don’t you also use subject ID in page of enrollment?
KA: Yes, the two pages are separated from each other, my idea behind this design is that the patient would initially obtain the “screening number” and after passing the eligibility criteria, they would subsequently get “randomization number”. The randomization number would be used for track the randomization arm that is why I placed the box nearby the randomization group. However, using the subject id is also good idea to simplify my eCRF and reduce redundancy. Thanks!-It is a randomized observed-blinded study. I am not sure that the type of groups can be recorded here or in a log book.
KA: Prof also mentioned this in my feedback, I also agree with this!-Also, from the protocol this study does not vary the volume of the vaccine. So, I am not certain that we need to record here.
KA: I recorded this just to keep track in case of overdose/underdose incidence.-Is it possible that the HAI titers can go up to 1:100 or more? If so, that means you may need more box(es).
KA: I missed this point, Could not agree more! Thanks!-I think the same as Sri, you may need vital sign and medical history sections.
KA: Thank you!-Is ‘randomisation group’ and ‘type of vaccine administered’ repeated each other?
KA: I added this just to keep track in case of wrong vaccine administration.-No anatomical location where the participant got the vaccine recorded.
KA: I missed this point, Thank you for your suggestion 🙂 -
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