Examples of FHCRC in a sentence
In addition, protocols are reviewed at least annually and as needed by the Consortium Data and Safety Monitoring Committee (DSMC), FHCRC Scientific Review Committee (SRC) and the FHCRC/University of Washington Cancer Consortium Institutional Review Board (IRB).
Under the provisions of this plan, FHCRC Clinical Research Support coordinates data and compliance monitoring conducted by consultants, contract research organizations, or FHCRC employees unaffiliated with the conduct of the study.
It is the responsibility of the FHCRC Principal Investigator to notify the sponsor, NIH, FDA or other agencies of serious adverse events as required in the protocol.
For Centers that have a Federal Wide Assurance (FWA), formal collaboration includes submission of a form 310 and a copy of the IRB approved protocol and consent forms to the FHCRC.
Collaborating Institutions: The principal investigator of the collaborating institution who will register the patient with the FHCRC will identify eligible patients.
The FHCRC and the local site’s IRB must review all protocol activities at least once annually.
As the coordinating center, FHCRC will monitor accrual at the outside institutions.
New protocols will undergo review at the FHCRC IRB and then will be distributed to sites that wish to participate for their IRB’s review.
No revisions may be implemented at outside institutions without the prior approval of the FHCRC Principal Investigator.
Patient was registered prior to treatment and approval by FHCRC PI occurs prior to randomization.