Regarding subject receipt of a signed and dated copy of the consent forms, which is true about fda regulations?
1. the fda regulations allow subjects or the legally acceptable representatives (lars) to receive either a signed or unsigned copy.
2. the fda regulations allow subjects to receive either a signed or unsigned copy.
ich e6 section 4.8.11 requires that the subject or the legally acceptable representative (lar) receive a copy of the signed and dated written informed consent form.
3. the fda (1998) regulations allow subjects to receive either a signed or unsigned copy.
4. to be in compliance with ich e6 guideline, the investigator should include a statement in the consent form that the subject will receive a signed and dated copy of the consent form. persons obtaining consent must then ensure that this procedure is followed.