Item
1. Subject study status at the time of review of updated Informed Consent
integer
Code List
1. Subject study status at the time of review of updated Informed Consent
CL Item
Subject currently on IP (23)
CL Item
Not applicable - subject no longer ongoing in study at time of reconsent (study withdrawal, lost to follow-up, died, *unable to contact subject in third party follow-up) (25)
CL Item
Subject who previously permanently stopped IP but remains in post-IP follow-up (including third party follow-up*) (24)
Date updated safety text reviewed with subject
Item
If subject currently on IP: Date updated safety text reviewed with subject
date
continuation IP confirmation
Item
If subject currently on IP: Has the subject confirmed they are continuing on IP?
boolean
Item
If subject currently on IP: Did the subject sign the updated Informed Consent form?
text
Code List
If subject currently on IP: Did the subject sign the updated Informed Consent form?
CL Item
Pending - waiting for subject to visit the clinic to sign the form (3)
CL Item
Yes, date subject signed the updated Informed Consent form (Y)
CL Item
No - subject confirmed that they will not sign. Subject must be withdrawn from IP if refuses to sign. Complete the EOT/EW IP visit. (N)
date subject signed the updated Informed Consent form
Item
If subject signed the updated Informed Consent form: date subject signed the updated Informed Consent form
date
Date subject informed of findings
Item
If Subject who previously permanently stopped IP but remains in post-IP follow-up: Date subject informed of findings
date