Users (Monitors, Medical Monitor, Data Manager, itd.) can add queries to every questions and pages of the eCRF by clicking in the particular question and/or page.
Patient data modification due to answers provided to queries results in removal of previous SDV
(or compliance) markers, so monitors have a clear indication which pages have to be re-checked.
Monitors can verify and confirm each question, pages, visit, filed. Data verified by a Monitor are
marked with a color check mark symbol. Color of marker indicates function of person who is
responsible for the verification (e.g. Monitor, Medical Monitor, Data Manager, etc.)
A physicians receives an automatic e-mail notification about new queries containing a link to the queried page. At the same time, the Investigator is temporarily given the option of editing a previously locked (frozen) page. If the physician changes data in eCRF, all markers are removed (broken) for this question, the page and/or the visit in which it occurred. Monitoring persons should verify the data again and approve the form.
Frequently asked questions.
