Q. How does IRB approval occur?
A. NMCCA utilizes several centralized IRBs for all participating sites. Most pharmaceutical-sponsored trials are sent to the Western IRB. NCI-funded trials are sent to the University of New Mexico’s IRB; some of the NCI trials also are reviewed by the NCI’s Central IRB. Each trial is assigned a regulatory coordinator who processes all the IRB applications and regulatory documents for all sites and serves as a single point of contact for the trial sponsor. The UNM IRB meets weekly.
Q. Has the IRB approved your protocol review committee?
A. Yes, all the IRBs NMCCA uses have approved our protocol review committee, the Protocol Review and Monitoring Committee (PRMC). The PRMC meets regularly, usually two times each month.
Q. Can the Sponsor decide which sites will participate in their trial?
A. The goal of NMCCA is to allow all our sites to enroll patients to any trial opened through NMCCA. We will work with each sponsor to identify the best sites for them.
Q. Will the Sponsor sign only one contract or will separate contracts be necessary for each NMCCA site?
A. NMCCA reviews the contract and budget for each trial; and executes all agreements. NMCCA will work with each Sponsor and each site to meet their specific contracting requirements.
Q. Are there any fees to initiate the trial?
A. NMCCA will charge non-refundable start-up fees to cover our cost to review and submit the necessary documents to the IRB for review. In addition, NMCCA will charge the Sponsor the IRB review fee, which is payable upon submitting the application. The Sponsor will also be responsible for the annual renewal fee. Some studies are so complex that we must spend a substantial amount of time analyzing the feasibility of opening the trial. In these instances, a separate feasibility fee may be charged.
Q. Will there be one principal investigator per trial for all sites?
A. Each site within the NMCCA will have its own principal investigator and sub-investigators. It is our preference to have each site complete a separate 1572 form. This allows for greater oversight of patients on a clinical trial within the scope of each practice. However, NMCCA is willing to work with each sponsor
to match sponsor requirements with tthe NMCCA network.
Q. Is there a centralized pharmacy to store drugs for all sites?
A. NMCCA prefers to have drugs shipped to each site participating in a trial. If necessary, we do have a central pharmacy that will manage the receipt of the drugs and dispense them to the individual sites. Drug Transfer Policy ver 7/15/2011
Q. Who will enroll patients and will competition for patients be an issue between participating NMCCA sites?
A. NMCCA will contract with the trial sponsor for an accrual target. The participating sites will work together to meet that target. The principal investigator(s) at each site will enroll patients and submit enrollment information to the sponsor.
Q. Who will be the liaison between the sites and the sponsor to handle correspondence, arrange site monitoring visits and manage queries?
A. NMCCA will be the liaison between all NMCCA-approved trials and their respective sponsors. We will coordinate monitoring visits and help manage queries with the Sponsor and our sites. SOP 3.3 Monitoring by a Sponsor
Q. Who will manage the regulatory documents, amendments and revisions?
A. NMCCA will manage all these documents for approved trials. A regulatory coordinator is assigned to each trial and is the project manager and liaison to the sponsor. If a protocol or consent form needs amendments or revisions, the Sponsor will send copies of all changes to the regulatory coordinator who will submit the documents to the IRB and will notify the principal investigators for the trial about the pending amendments or revisions. Once the IRB approves the documents, NMCCA will forward them to the principal investigators.
SOP 3.6 Handling of Amendments and Revisions
Q. Who will complete and manage the case report forms (CRFs)?
A. The research coordinator for each site will complete the case report forms and forward the paperwork to the respective sponsors.
SOP 4.3 Subject Management While on Study
Q. Who will report internal Adverse Events (AE) and Serious Adverse Events (SAE)?
A. If any AEs occur, the research nurse generates an Adverse Event Report. The principal investigator signs and dates the report and sends it to the IRB of record and the study sponsor. If an SAE occurs, the research nurse generates the report and ensures that the Sponsor receives a copy within the protocol’s requirements of reporting.
SOP 4.4 Adverse Event Reporting
Q. What happens if there is an external Adverse Event?
A. Sponsors send external adverse event reports to the regulatory coordinator at NMCCA. External adverse events not meeting the following 3 criteria are not considered non-reportable. These are not to be reviewed, retained or otherwise managed by the NM Cancer Care Alliance investigators or staff. Non-medically significant external adverse events are logged as directed by the IRB of record.
1. Unanticipated
2. Related or possibly related to participation in research and
3. Serious, placing the subject or others at a greater risk of physical or psychological harm than was previously known or recognized SOP 3.9 External Adverse Event Safety Reports
Q. Who will be responsible for protocol compliance and oversight?
A. The PI at each site is responsible for protocol compliance. However, NMCCA has a Quality Assurance program which includes internal retrospective audits.
