Typically, we get sites to submit a radiation report from their local physicists that will contain their site-specific radiation wording for the PICF. Under the new set up, does Bellberry want the actual radiation report to still be submitted, or can sites just use the Site-Specific Clauses form for their site-specific radiation wording?
The Committee will want to see the radiation report (if above standard of care) and the wording from that report placed in the site-specific wording doc. The HREC notes the radiation report, whereas they approve the site-specific wording.
If the lead has already imbedded the radiation report wording of multiple sites into the Master PICF, then it would not need to be put in the site-specific doc.