#3: a - A patient/study participant would need to authorize use of his/her PHI. This cannot be waived by an IRB.
#4 d -The question is about other data entry fields in general, not just those that would be ideal for text.
#6 b -Only changes that could potentially lead to a loss of data, such as changing the name of a variable,for example, must be approved by an administrator. If you did something like add field note, this could be implemented immediately.
I hope this is helpful.
Rita
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