| How the CIRB process
works - a synopsis |
1. |
The Adult or Pediatric CIRB receives a completed application,
protocol, informed consent form and related materials from the
Cooperative Group via the NCI. |
|
2. |
The full Board conducts initial review and approves the
protocol. (Click on "How
it works - in detail" for information on other review outcomes.) |
3. |
After the protocol is activated by the Cooperative Group, all
review documents are posted on the website for access by
participating institutions.
|
4. |
A local investigator at a participating institution decides to
enroll subjects in a CIRB-approved protocol. Either the
investigator or local IRB downloads the application packet for
facilitated review. |
5. |
The local IRB chair/subcommittee conducts a facilitated
review, concentrating on local context issues. |
6. |
The local IRB notifies the CIRB Administrative Office of
facilitated review acceptance via the website. |
7. |
The CIRB becomes the IRB of Record for this protocol and is
responsible for continuing review as well as review of
subsequent amendments and serious adverse events (SAE) as
notified by the Group. |
8. |
Local IRB is responsible for review of local SAEs and oversight
of local conduct of the study. |
