A new staff member responsibility has been added to the Staff section to allow a Proxy signatory for CLARA submissions, other than the New Submission form.
In the “Staff” section of a new submission or modification form, the following help text has been added:
Only a Co-Investigator or Sub-Investigator may be assigned the Proxy signatory for CLARA submissions responsibility.
When adding a new staff member or updating a responsibility for an existing staff member, the following Responsibility has been added:
Proxy signatory for CLARA submissions – The Principal Investigator (PI) may grant the responsibility of proxy signatory to a qualified person, either a Co-Investigator or a Sub-Investigator. This designated responsibility is for CLARA submissions only, other than the initial submission, under extenuating circumstances. The PI remains responsible for the overall conduct and oversight of the study per IRB Policy 10.4.
This new responsibility may not be added using a Staff Only Modification form. There are several alerts to remind CLARA users that Staff Only Modification form may not be used for a change in PI or Proxy.