Below is information for processes that occur while a study is active, whether the study involves accruing participants or analyzing data.
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.
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.
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.
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.