Our Master PICFs can have optional wording in the body of the PICFs so sites can select the relevant statement for their site and delete the other e.g. 2 radiation statements. Which of the 2 options below is correct?
- Does not need to be listed in site-specific clauses document as the wording has been ethically approved in the Master PICF, so site deleting the not applicable section would be a known admin change.
- Copy and paste the deleted wording into the site-specific clauses template stating that it is not applicable and therefore deleted.
The correct answer is option 1.