Subject took away the PIL and has signed the consent form at home, several days prior to the Investigator. I haven't seen this before. Is this OK?
From the RQA website: If the subject signs the consent form at home and not in the presence ofthe investigator (or suitably qualified & delegated designee), theinvestigator cannot verify who actually gave consent and the circumstancesunder which consent was obtained. If a consent form has already been signed at home,the subject can simply re-sign & date the form in the presence of theinvestigator (or suitably qualified & delegated designee) and then theinvestigator signs & dates the form during the same interview.
The CRA reports that the MPA (Swedish regs) and IEC both say its OK that the subject has signed before the Investigator.
Your thoughts?