What other method of documentation may be used to record the consent
process, in addition to the executed consent form?
- Additional
documentation of the informed consent process is not an IRB requirement however,
Good Clinical Practice Guidelines suggest that the process be documented in
some way. For some clinical trials, the discussion with the subject regarding
participation and the informed consent process must be documented. This could
be in a dated note in the subject's research file or it could be part of a
clinical note in their medical record.