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Data Monitoring Committees (DMC) and Data Safety Monitoring Boards (DSMB) Definitions, Procedures and Tools.

The list of Terms and definitions related to DMCs and DSMBs:

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Academic Research Organization (ARO)


Typically, part of a university, publicly or privately funded, for- or not-for-profit, provide expertise in medical, scientific or technical fields.

Chairperson

The person who presides a committee and ensures procedures are followed as per Charter. 

Charter

A document describing all roles and processes of a committee.

Closed session

A session of the DMC that cannot be attended by sponsor representatives because unblinded information is shared.

Committee 

A group of persons supervising a clinical trial.

Coordinator(s)

The staff person(s) coordinating a committee’s operations and procedures. 

Data Monitoring Committee (DMC)

A group of independent experts external to a study assessing the progress, safety data and, if needed, critical efficacy endpoints of a clinical study.

Data Safety Monitoring Board (DSMB)

Same as the DMC.

Endpoint Adjudication Committee

Also called Endpoints Adjudication Committee or Clinical Event Committee. A group of experts independently reviewing clinical events during a clinical trial.

Ethics Committee (EC)

The responsibility of an Ethics Committee is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial.

Executive closed session

A session of the DMC attended by the DMC Chair and specified sponsor representatives to discuss the recommendations of the DMC.

Form(s)

Used by the Committee members to perform and record their assessment. The forms can be processed as paper or, as online fillable forms.

Open session

A session of the DMC that can be attended by sponsor representatives.

Quality Control

A set of procedures, measurements and metrics used to control and maintain the quality of the process and outcomes.

Reviewer(s)

Independent expert(s) in charge of a clinical trial’s assessment.

Reviewers Qualification

The procedures ensuring that every Reviewer included in the Committee is well qualified (with appropriate training) for the Clinical Assessments requested by the Charter. 

Steering Committee

Acts as a body that takes responsibility for the scientific integrity of a clinical trial, the scientific validity of the study protocol, the study quality, and the scientific quality of the final study report.

Study Team

The Study Team consists of members from the sponsor’s staff from different disciplines overlooking the daily work of a clinical study.

Workflow

The procedure, as described in the Committee Charter, by which the review is made.
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