Clinical Trials Oversight
Clinical Trials Oversight
Ensure the rights and well-being of subjects are protected, data is accurate, complete, reliable and that the trial is conducted in compliance with the protocol, ICH-GCP and applicable regulatory requirements.
Support We Provide
Data Safety Monitoring Board
Everything you need to know to create a DSMB
Study Monitoring
Assistance with clinical research monitoring on investigator-initiated study trials.
Independent Safety Monitor
Assistance with clinical research monitoring on investigator-initiated medical trials.
Independent Quality Checks/Audits
Review of study conduct early in the research process
FAQs
-
All clinical trials require study oversight to ensure the rights and well-being of subjects are protected, data is accurate, complete, reliable and that the trial is conducted in compliance with the protocol, International Council for Harmonization Good Clinical Practices (ICH-GCP) and applicable regulatory requirements.
Study oversight can be completed in different ways and is outlined in the Data Safety Monitoring Plan (DSMP). Oversight may be completed internally, within the study team or externally through an independent agency.
Internally, the study team may conduct quality checks and data reviews.
Externally an independent Data Safety Monitoring Board (DSMB) or Data Safety Monitoring Committee (DSMC) may review data summaries, subject enrollment and adverse events. An independent Safety Monitor may review safety data and adverse event attributions. An independent study monitor may complete source verification and regulatory compliance reviews. Additionally, the institution, the IRB, the FDA and/or the study funder may require annual reporting and may conduct audits to monitor the progress of the study and validity of the data.
-
The type(s) of clinical trial oversight is determined as a collaboration between the study sponsor, study funder, the FDA (for FDA regulated studies), IRB of record and the institution conducting the study.
The types of clinical trial oversight for a particular trial depends on the types of risks and complexity of the trial itself. Oversight for each clinical trial should be customized to match the risks and complexity it entails.
FDA guidance (PDF) requires DSMB or DSMCs for large, randomized, multi-site clinical trials and for any controlled trial that compares rates of mortality or major morbidity. They recommend weighing the need on three main categories including 1) the risk to trial participants; 2) whether a DSMB review is practical; 3) whether the DSMB will help assure the scientific validity of the trial.
The NIH has their own requirements for DSMPs and DSMB, with each institute holding additional requirements. When submitting a grant application to the NIH it is impertinent that the researcher is familiar with those requirements.
The Ohio State University Institutional Policy requires DSMBs for studies that involve a highly favorable or unfavorable outcome that might ethically require termination of the study before planned completion; existing data suggests the possibility of serious toxicities from the study procedure; the study involves vulnerable participants (ex. children, disadvantaged); the participant population is at an increased risk of death or serious outcome; or the study is large, of long duration and includes multiple sites.
-
Data safety monitoring plans should include detailed plans for both real time and ongoing safety monitoring.
The plan for real time safety monitoring should include:
- The detailed plan to assess safety events, in real time, for each of the study participants
- Outline any required actions, such as dose modifications or study stopping actions, that need to be completed if specific safety events are identified
- Any reporting criteria for these real time safety events
The plan for ongoing safety monitoring should include:
- Who will perform monitoring activities and identify any relationship they have to the research
- Specific data and events that will be monitored
- The composition of the monitoring group (if applicable)
- Monitoring and/or meeting frequency
- Reporting mechanisms and timeframes from study team to DSMB, IRB, NIH, etc.
- Procedures for analysis and interpretation of the data
- Definitions of specific events or endpoints that require action to be taken
- Procedures for and frequency of communication from monitoring board to appropriate entities (investigators, IRBs, NIH, etc.)
- Other information required by the funding agency
Get help with developing a data safety monitoring plan.
-
The members DSMB/DSMC members should be independent of the study team and should not have any conflict with the study sponsor and/or the drug or device sponsor.
Established DSMB/DSMCs at The Ohio State University include the CTSI DSMB and the CCC DSMC. If conducting an Investigator Initiated oncology interventional trial the CCC DSMC should be used. For all other studies the CTSI DSMB or another independent DSMB, such as WCG DSMB or Advarra DSMB, may be used.
Request a consultation to set up a DSMB through the CTSI DSMB.
-
The Independent Safety Monitor should be independent of the study team and should not have any conflict with the study sponsor and/or the drug or device sponsor.
-
The Independent Study Monitor should be independent of the study team and will work under oversight of the study sponsor but should be independent of the research study team conducting the study.
-
The Independent Auditor may work under oversight of the study sponsor or may be external to the study sponsor. The Independent Auditor should be independent of the research study team conducting the study.