Print Friendly Page

Funding

Photo of two institute staff members in a meeting

Clinical Research

Updated September 10, 2007

DSMB Charter

Draft
DSMB Charter
Title
Dr. XX, M.D., Principal Investigator
Site

The Data Safety Monitoring Board (DSMB) will act in an advisory capacity to NIAMS to monitor patient safety and evaluate the efficacy of the intervention. Dr. who, University of what, where is conducting a clinical trial entitled, "title" under contract with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

The initial responsibility of the DSMB will be to approve the initiation of this clinical trial. After this approval, and at periodic intervals (to be determined) during the course of the trial, the DSMB responsibilities are to:

review the research protocol, informed consent documents and plans for data safety and monitoring;

evaluate the progress of the trial, including periodic assessments of data quality and timeliness, participant recruitment, accrual and retention, participant risk versus benefit, performance of the trial site, and other factors that can affect study outcome;

consider factors external to the study when relevant information becomes available, such as scientific or therapeutic developments that may have an impact on the safety of the participants or the ethics of the trial;

review clinical center performance, make recommendations and assist in the resolution of problems reported by the PI;

protect the safety of the study participants;

report on the safety and progress of the trial;

make recommendations to the NIAMS, the PI, and, if required, to the FDA concerning continuation, termination or other modifications of the trial based on the observed beneficial or adverse effects of the treatment under study;

if appropriate, conduct interim analysis of efficacy in accordance with stopping rules which are clearly defined in advance of data analysis and have the approval of the DSMB;

ensure the confidentiality of the trial data and the results of monitoring; and,

assist NIAMS by commenting on any problems with study conduct, enrollment, sample size and/or data collection.

Membership

The Data Safety Monitoring Board will consist of 5 members. Three members will constitute a quorum. The members have been recommended by Dr. who (PI), the NIAMS has approved the composition of the DSMB, and appointed the members. Membership consists of persons completely independent of the investigators who have no financial, scientific, or other conflict of interest with the trial. Current or past collaborators or associates of Dr. PI are not eligible to serve on the DSMB. Written documentation attesting to absence of conflict of interest is required. The DSMB includes experts in or representatives of the fields of:

relevant clinical expertise,
clinical trial methodology, and
biostatistics.

Dr. who, University of ?, has been selected by NIAMS in consultation with the PI to serve as the chairperson. He is responsible for overseeing the meetings, developing the agenda in consultation with the NIAMS Project Officer and the PI. The chair is the contact person for the DSMB. The NIAMS staff (Project Officer or his/her designee) will serve as ex-officio member. The University of site, where shall provide the logistical management and support of the DSMB.

A safety officer will be identified at the first meeting. This person will be the contact person for severe adverse event reporting. Procedures for this will be discussed at the first meeting.

Board Process

The first meeting will take place face-to-face before initiation of the trial to discuss the protocol, approve the commencement of the trial, and to establish guidelines to monitor the study. The NIAMS Project Officer and PI will prepare the agenda to address the review of manual of operating procedures, initiation of the trial, identification of a safety officer, reporting of adverse events, stopping rules, interim analysis plan, etc.

Meetings of the DSMB will be held 2 times a year at the call of the Chair, with advance approval of the NIAMS Project Officer. A NIAMS representative(s) will be present at every meeting.

Meetings shall be closed to the public because discussions may address confidential patient data. Meetings are attended, when appropriate, by the principal investigator and members of his/her staff. Meetings may be convened as conference calls as well as in person, although the initial meeting and meetings to discuss interim analysis will be face-to-face. An emergency meeting of the DSMB may be called at any time by the Chairperson or by NIAMS should questions of patient safety arise.

Meeting Format

An appropriate format for DSMB meetings consists of an open and a closed session. The open sessions may be attended by the principal investigator(s), institution staff and NIAMS staff, but should always include the study biostatistician. Issues discussed at open sessions will include conduct and progress of the study, including patient accrual, compliance with protocol, and problems encountered. Patient-specific data and treatment group data may not be presented in the open session.

The closed session will be attended only by voting DSMB members and NIAMS staff. Others may be requested to attend by the DSMB (e.g., study statistician). All safety and efficacy data are and must be presented at this session. The discussion at the closed session is completely confidential.

Should the DSMB decide to issue a termination recommendation, full vote of the DSMB will be required. In the event of a split vote, majority vote will rule and a minority report should be appended.

Reports

Interim Reports. Interim reports are generally prepared by the study statistician(s) and distributed to the DSMB at least 10 days prior to a scheduled meeting. These interim reports are numbered and provided in sealed envelopes within an express mailing package. The contents of the report are determined by the DSMB. Additions and other modifications to these reports may be directed by the DSMB on a one-time or continuing basis. Interim data reports generally consist of two parts. Part 1 (Open Session Report) provides information on study aspects such as accrual, baseline characteristics, and other general information on study status. Part 2 (Closed Session Report) may contain data on study outcomes, including safety data and depending on the study, perhaps efficacy data. The Closed Session Report is considered confidential. Copies distributed prior to and during a meeting are collected by the study statistician(s) following the meeting. Data files to be used for interim analyses should have undergone established editing procedures to the extent possible. Interim analyses of efficacy data are performed only if they are specified and approved in advance and criteria for possible stopping is clearly defined.

Reports from the DSMB. A formal report from the Chair will be sent to the full DSMB within 3 weeks of the meeting. Once approved by the DSMB, the Chair will forward the approved minutes to NIAMS within 6 weeks of each meeting. NIAMS will forward the DSMB report to the PI.

Each report should conclude with a recommendation to continue or to terminate the study. This recommendation should be made by formal majority vote. A termination recommendation may be made by the DSMB at any time by majority vote. The Chair should transmit such a recommendation to the NIAMS as rapidly as possible, by immediate telephone and telefax if sufficiently urgent. NIAMS would then notify the PI. In the event of a split vote in favor of continuation, a minority report should be contained within the regular DSMB report. The report should not include unblinded data, discussion of the unblinded data, etc.

Mailings to the DSMB: On a scheduled basis (as agreed upon by the DSMB) blinded safety data should be communicated to all DSMB members or to the designated safety officer (to be determined at the first meeting). Any concerns noted should be brought to the attention of the Chair or designated safety officer who will take appropriate action.

Access to Interim Data: Access to the accumulating endpoint data should be limited to as small a group as possible. Limiting the access to interim data to the DSMB members relieves the investigator of the burden of deciding whether it is ethical to continue to randomize patients and helps protect the study from bias in patient entry and/or evaluation.

Confidentiality

All materials, discussions and proceedings of the DSMB are completely confidential. Members and other participants in DSMB meetings are expected to maintain confidentiality.