Institutional Review Board
Guidance for Data Monitoring Plans
Related Guidance Documents:
IRB Continuing Review-Ongoing, Reporting New Information
Data Monitoring Committees - FDA March 2006 “Guidance for Clinical Trial Sponsors”
Data Monitoring Plans and Data Monitoring Committees – NIH and NCI policies
Data monitoring plan:
A Data Monitoring Plan is required for:
• All studies considered more than minimal risk.
• Multi-site research where MMC is the coordinating site.
• Studies where there is an NIH or FDA requirement for a plan.
• Studies when requested by the IRB.
The plan should describe how the Principal Investigator (PI) will ensure that there is oversight of the research participant’s safety and welfare and how unanticipated problems involving risks to participants or others, and adverse events will be characterized and reported. The plan should be tailored to the nature, size, and complexity of the research, the expected risks, and the type of subject population being studied. [OHRP guidance]
When is a data safety monitoring plan required?
The IRB requires that any study which is considered more than minimal risk have a data safety monitoring plan. Examples of non-medical studies requiring a DSMP might include highly sensitive surveys, the use of novel therapeutic modalities or novel manipulations of the participant’s environment. Examples of medical studies requiring a DSMP might include blinded studies, studies which use high-risk intervention or a new unfamiliar intervention not otherwise categorized as a Phase III clinical trial, a novel surgical technique or the use of novel devices.
When is a data safety monitoring board required?
All phase III clinical interventions must have a DSMB or equivalent body (and an accompanying data safety monitoring plan). An equivalent body or alternatives to a DSMB might include an industry-sponsored data safety monitoring committee, a NIH sponsored cooperative group, or a monitoring committee formed by a sponsor other than NIH.
Monitoring entity
The monitoring entity should be described in the Data Monitoring Plan submitted with the IRB Application.
• The monitoring entity is an identified individual (Medical Monitor) or group (DSMB, DSMC) assigned to conduct interim monitoring of accumulated data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. Membership should include expertise in the relevant field of study, statistics and research design.
• The monitoring entity might be the assigned Medical Monitor, a Data Monitoring Board, or an equivalent body such as an industry-sponsored Data Monitoring Committee (DMC), a NIH sponsored cooperative group, a coordinating or statistical center, a monitoring committee formed by a sponsor other than NIH, or a sponsor’s Medical Monitor (an individual rather than a DMC).
• FDA-regulated studies: See guidance Data Monitoring Committees - FDA March 2006 “Guidance for Clinical Trial Sponsors”.
• NIH-sponsored studies: See guidance Data Monitoring Plans and Data Monitoring Committees – NIH and NCI policies
What a data monitoring plan can include?
Investigators are required to describe their Plan, if applicable, as a part of the IRB Application.
The Plan, as appropriate to the risks, size and complexity of the study, might address the following:
(1)Types of data or events that are to be captured under the monitoring plan.
(2) Responsibilities and roles for gathering, evaluating and monitoring the data.
Information about the monitoring entity (OHRP notes that the IRB has authority to observe or have a third party observe the research.) OHRP 45 CFR 46.109(e)
(3)Time frames for reporting adverse events and unanticipated problems to the monitoring entity.
(4) The frequency of assessments of data or events captured by the monitoring plan.
(5) Definition of specific triggers or stopping rules that serve as the criteria for action.
(6) As appropriate, procedures for communicating to the IRB, the study sponsor, and other appropriate entities the outcome of the reviews by the Monitoring Entity.
Data Monitoring Plan - Template
(1) Types of Data or Events:
- Describe data or events that will be captured under the Data Monitoring Plan
(2) Responsibilities and roles for gathering, evaluating and monitoring the data:
- Including data related to unanticipated problems and adverse events
- E.g., roles of the investigators, research coordinators, research sponsor, monitoring entity, statistical consultant, etc.
- Who will verify data accuracy, by what method, and how frequently?
- Who will verify compliance with the protocol, how, and how often?
(3)Information about the monitoring entity:
- Description (e.g. individual Medical Monitor, Data Monitoring Committee (DMC) consisting of <number> members, etc.)
- Information about each member - e.g. name, credentials, title, organization, contact information (unless there is no Sponsor or external monitoring entity)
- Mechanisms to assure independence of judgment
(4) Reporting adverse events and unanticipated problems to the monitoring entity:
- Timeframes for reporting
- What mechanism will be used to report (specify forms, procedures)
- Who will be preparing and submitting the forms
(5)Assessments:
- Frequency with which monitoring entity will review and assess the data or events captured under the Data Monitoring Plan (e.g., monthly, quarterly, etc.). Monitoring entity will review data and events according to assessment criteria for “unanticipated problems involving risks to participants or others” (i.e., as to whether they are unexpected, related, and increase risk).
(6)Criteria for action:
- Description of specific triggers that will dictate when some (specified) action is required.
- Description of stopping rules for terminating the study.
(6) Procedures for communicating – disseminating safety information:
As appropriate:
- How outcomes of monitoring entity reviews will be communicated to the IRB, research sponsor, other entities (e.g. other study sites).
Page 1 of 3 / SOP # FO 301-E Effective Date 10/01/2010 Supersedes NA