I assume that the ISF is the Investigator Site File and is under the control of the investigator? Why would redaction be necessary? You are not releasing the consent forms to outside of the investigator site. Obviously I must have misunderstood.
I assume that the ISF is the Investigator Site File and is under the control of the investigator? Why would redaction be necessary? You are not releasing the consent forms to outside of the investigator site. Obviously I must have misunderstood.
Hi a123456,
Yes, i did mean Investigator Site File, which is stored at site under control of the investigator.
We were advised that the consent forms would need to be redacted (in preparation for potential inspection) as this must be done 'by law'. This is not something that we have heard of before so i thought i would ask to see if this was the case (new legislation for example). The consent forms would expected to be checked, but would not be removed by inspectors either as far as i am aware.
Sorry for not being clear.