Below is information for processes that occur while a study is active, whether the study involves accruing participants or analyzing data.
Monitoring
Clinical Research Support (CRS) conducts protocol monitoring according to the NCI-approved Institutional Data and Safety Monitoring Plan. Clinical research studies that are not monitored by another entity will be monitored by CRS.
The frequency and the scope of the monitoring are determined by the risk level of the study. Studies that support an IND held by a Consortium investigator or meet the NIH definition of high risk are monitored twice per year. Studies designated as medium risk are monitored every 12-24 months.
Protocol Revisions
Study modifications that impact study participants require updates to federal registries and may require additional review by the SRC.
Clinical Trial Registries
Depending on the type of study, Clinical Research Support may submit amendments to NCI's Clinical Trials Reporting Program (CTRP) and process the corresponding updates on ClinicalTrials.gov.
Scientific Review Committee (SRC)
Study modifications of certain study types may require SRC review. If scientific elements are modified, as described in the SRC Modification Form, the revision must be submitted for full SRC review.
If no scientific elements are modified or if the study has an industry or NCTN sponsor, no SRC review of the modification is required.
Annual Renewal
Follow-up reviews are required for several of the bodies that review studies initially. Generally the review cycle is once a year, but it is sometimes more frequent. Below you'll find information about some of the review processes you may encounter during the conduct of a study.
Institutional Review Board (IRB)
Federal regulations governing IRBs, including HHS regulation 45 CFR 46.109(e) and FDA regulation 21 CFR 56.109(f), require that the IRB review human subjects research at intervals appropriate to the degree of risk, but not less than once per year. Learn more about the IRB process on their website.
Radiation Safety Committee
Radiation Safety Committees require review yearly. There are procedures that govern radiation safety reviews for Fred Hutch studies and for UW/Fred Hutch Consortium studies. Learn more about the Radiation Safety Committee process on their website.
Data and Safety Monitoring Committee (DSMC)
Cancer-related investigator-initiated clinical trials with an intervention involving a drug, device, or biologic are subject to annual review by the DSMC.
The DSMC reviews study information depending on type of trial and may recommend a Full Approval, a Conditional Approval, or a Suspension.
Data and Safety Monitoring Board (DSMB)
Local Consortium DSMBs periodically assess safety-related data for applicable, ongoing cancer-related trials. The need for a DSMB should be established by the Principal Investigator during study design by referencing the requirements stated in the Institutional Data and Safety Monitoring Plan (DSMP), but may also be determined during or after initiation by the SRC, IRB, or the DSMC. A DSMB Charter is required for all investigator-initiated studies that have a DSMB. The CRS Compliance Team DSM Coordinator provides administrative support for local Consortium DSMBs (as noted in the Institutional Data and Safety Monitoring Plan) and is contacted by the study team when upcoming meetings are initiated or scheduled.
Food and Drug Administration (FDA)
An IND sponsor is required to submit an annual report summarizing the progress of the clinical investigation and information obtained during the previous year's clinical and non-clinical investigations. The format and content of the annual report are described in 21 CFR 312.33.
The annual report is due within 60 days following the anniversary date that the IND went into effect. For example, if an initial IND submission was received by FDA on March 16, 2022, and FDA did not have any comments or questions, then the IND went into effect on April 15, 2022 (after the 30-day review period). Thus, the annual report is due on or before June 14, 2023 and by June 14 of each subsequent year.
The annual report is not a “renewal” document, in the sense that FDA does not issue approval for INDs. However, it is a significant responsibility that the sponsor is obligated to fulfill in order to maintain an active IND.
Scientific Review Committee (SRC)
The SRC monitors ongoing studies for scientific progress, including accrual rates according to the Consortium Low Accrual Policy.
Contact Us
Clinical Research Support is here to assist and guide study teams. Please contact us if you need anything not found in these resources, or need clarification on how to proceed with your study.