What is the IRB approval process and who will manage submissions?
For all WVCTN clinical trials the Chesapeake IRB (CIRB) is utilized. Some NCI-trials are also reviewed by the NCI’s Central IRB. The CIRB meets daily (Mon-Fri), except on holidays. A different central IRB may be used if specifically requested by a sponsor.
A single Regulatory Coordinator will process all IRB submissions for the network sites, and will serve as a single point of contact for the sponsor. Any protocol or consent form amendments can be sent from the sponsor to the Regulatory Coordinator, who will ensure member sites are aware of pending revisions. Where a centralized IRB is being used the sponsor may directly submit study amendments and revisions to the IRB.
Is your protocol review committee IRB approved?
Yes, WVU IRB and CIRB have approved our Protocol Review and Monitoring Committee (PRMC). The PRMC meets bi-monthly. For more information regarding our PRMC see: http://wvucancer.org/ctru/Investigator-Services/PRMC-Submission
Can the sponsor decide which sites will participate in their trial?
WVCTN aims to have a minimum of 50% of the network sites participating in a trial, with the goal of having all sites open for enrollment. We will work with each sponsor to determine which sites best fit the needs of a trial.
Will separate contracts be necessary for each WVCTN site, or will there be one contract?
WVCTN has the authorization from the member sites to review the budget and contract on their behalf, so only one contract will need to be signed.
Are there any fees to initiate the trial?
There is a non-refundable study start-up fee charged by WVCTN. If CIRB is used, they will bill the sponsor directly.
Will there be one Principal Investigator per trial for all sites?
Yes, there is a single Principal Investigator for the WVCTN, and each of the member sites will identify a Sub-Investigator. Each of these investigators will be identified on the FDA 1572.
Is there a centralized pharmacy to store drugs for all sites?
WVCTN prefers to have study drugs shipped directly to each network site.
Who will enroll patients?
WVCTN network sites will work together to enroll the target number of patients for each study. The investigators at each site will be responsible for enrolling patients in their local area.
Who will be the liaison between sites and the sponsor to handle correspondence, arrange site monitoring visits and manage queries?
The WVCTN Network Coordinator will serve as a single point of contact and will liaise between network sites and sponsor.
Who will complete and manage the case report forms (CRFs)?
The Research Coordinator and/or the Data Manager at each WVCTN member site will be responsible for data submission, both electronically and hard copies as required by the study sponsor.
Who will report internal Adverse Events (AEs) and Serious Adverse Events (SAEs)?
The Research Coordinator and Investigator at each member site will be responsible for reporting internal AEs, SAEs and UPIRTSOs as required by the IRB of record.
What happens if there is an external IND safety report?
The sponsor must send external IND safety reports to the WVCTN Regulatory Coordinator who will determine if the criteria for IRB submission has been met. External IND safety reports will be submitted to the IRB only if the report necessitates a change in the protocol and/or informed consent form by the study sponsor.
Who will be responsible for protocol compliance?
The Investigator at each site will be responsible for protocol compliance. In addition, WVCTN will provide continual oversight and will conduct internal quality assurance audits.