Introduction - UCL by wuzhengqin


									Charter of the Independent Data Monitoring Committee (IDMC)

Charter of the Independent Data Monitoring Committee (IDMC)

Protocol Title:

Sponsor’s Protocol Number:

Short Title:

EudraCT Number:

Version Number:

University College London
Maple House, First Floor
149 Tottenham Court Road

Chief Investigator:
Site Address::

IDMC Charter Template Version 1, 19/02/2010                              Page 1 of 6
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Charter of the Independent Data Monitoring Committee (IDMC)

Outline of scope of charter: The purpose of this document is to describe the roles and
responsibilities of the IDMC for the (enter study title and sponsor ID number) trial, including the timing of
meetings, methods of providing information to and from the IDMC, frequency and format of meetings,
statistical issues and relationships with other committees.


 Objectives      of     trial,   including    Insert objectives of trial, including interventions being investigated from
 interventions being investigated             protocol. Include a flow chart of the trial design (Figure 1).

 Outline of scope of charter                  The purpose of this document is to describe the roles and responsibilities of
                                              the independent IDMC for the above trial.

 A broad statement of the aims of the          To safeguard the interests of trial participants, assess the safety and efficacy
 committee                                    of the interventions during the trial, and monitor the overall conduct of the
                                              clinical trial.
                                              The IDMC should not make decisions about the trial, but rather make
                                              recommendations to the Trial Management Group (TMG).
                                              The IDMC is independent of, but reports to, the TMG

 Terms of reference                           The IDMC should receive and review the progress and accruing data of this
                                              trial and provide advice on the conduct of the trial to the Trial Management
                                              The IDMC should inform the Chair of the Management Group if, in their view:
                                              (i) there are concerns about the safety of one or more of the treatment arms
                                              (ii) the results show a benefit of one treatment arm over another that is so
                                              large, and precise, that it is likely to convince a broad range of clinicians to
                                              change practice
                                              (ii) it is evident that if the trial continued it would fail to show a clear benefit for
                                              any treatment arm
                                              (iv) accrual is so low that it is unlikely that a sufficient number patients would
                                              be recruitment to provide meaningful results
                                              A short competing interest form should be completed and returned by the
                                              IDMC members to the trial coordinating centre (Annex 1).

 Specific roles of IDMC                       Interim review of the trial’s progress to:
                                                  monitor evidence for treatment harm (eg toxicity data, SAEs, deaths)
                                                  suggest additional data analyses (using blinded data where possible) for
                                                   example, of main outcome measures, but only where this is relevant to the
                                                   trial continuing or stopping early
                                                  decide whether to recommend that the trial continues to recruit
                                                   participants or whether recruitment should be terminated either for
                                                   everyone or for some treatment groups and/or some participant subgroups
                                                  monitor planned sample size assumptions and recommend amendment if
                                                  monitor recruitment figures and losses to follow-up
                                                  advise on major protocol modifications suggested by investigators or
                                                   sponsors such as changing the main endpoints

IDMC Charter Template Version 1, 19/02/2010                                                                            Page 2 of 6
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Charter of the Independent Data Monitoring Committee (IDMC)

                                                     assessment of data quality, including completeness
                                                     monitor compliance with the protocol by participants and investigators
                                                     monitor continuing appropriateness of patient information
                                                     considering the ethical implications of any recommendations made by the
                                                     assess the impact and relevance of external evidence

 Input to the trial protocol                      All potential IDMC members will have sight of the protocol/outline before
                                                  agreeing to join the committee.
 Timing of first meeting                          The IDMC will meet either before the trial starts or within one year of
                                                  recruitment commencing, to discuss the protocol, the trial, analysis plan, and
                                                  future meetings.
 Regulatory implications                          The IDMC should be aware of any regulatory implications of their

 IDMC contract                                    Members of a IDMC will have a contract making clear the need for
                                                  confidentiality and the liability status of the IDMC members. When there is no
                                                  such contract, IDMC members could formally register their assent by
                                                  confirming (1) that they agree to be on the IDMC and (2) that they agree with
                                                  the contents of this Charter.

 List of IDMC members                             The members of the IDMC for this trial are:
                                                           (1) [---give name---]
                                                           (2) [---give name---]
                                                           (3) [---give name---]
 Choice of chair                                  The Chair will be chosen by the investigators or IDMC members, and is
                                                  expected to facilitate and summarise discussions.

 The responsibilities          of   the   trial   The trial statistician will produce (or oversee the production of) the report to the
 statistician                                     IDMC and will participate in IDMC meetings, guiding the IDMC through the
                                                  report, and participating in IDMC discussions.

 The responsibilities of the trial office         The trial office team (eg Trial Co-ordinator) may input to the production of the
 team                                             non-confidential sections of the IDMC report.

 The responsibilities of the Chief                The CI may be asked to attend open sessions of the IDMC meeting. Other
 Investigator (CI) and other members of           TMG members will not usually attend but may attend open sessions when
 the Trial Management Group (TMG)                 necessary.

 Expected frequency of IDMC meetings              The frequency of meetings will depend upon the IDMC and the progress of the
                                                  trial. It is recommended that the IDMC meet at least yearly, either face-to-face,
                                                  or by teleconference or email

 How IDMC meetings will be organised,             Closed sessions: Members of the IDMC and the trial statistician.
 especially regarding open and closed             Open sessions: Members of the IDMC and the trial statistician, principle
 sessions, including who will be present          investigators, trial co-ordinators.
 in each session
                                                  The format of the meetings will be:
                                                  1. Open session: Introduction and any “open” parts of the report
                                                  2. Closed session: IDMC discussion of “closed” parts of the report
                                                  3. If necessary, further discussion with other attendees on any matters arising
                                                  from the previous session(s).
 Payments to IDMC members                         Members will be reimbursed for travel and accommodation

IDMC Charter Template Version 1, 19/02/2010                                                                             Page 3 of 6
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Charter of the Independent Data Monitoring Committee (IDMC)


 Intended content of material to be           Open sessions: Accumulating information relating to recruitment and data
 available in open sessions                   quality (eg data return rates, treatment compliance) will be presented. Toxicity
                                              details based on pooled data will be presented and total numbers of events for
                                              the primary outcome measure and other outcome measures may be
                                              presented, at the discretion of the IDMC.

 Intended content of material to be           Closed sessions: In addition to all the material available in the open session,
 available in closed sessions                 the closed session material will include safety data by treatment group. It may
                                              include efficacy data by treatment group, depending on the planned interim

 Will the IDMC be blinded to the              Data reported by treatment group should be blinded where possible, unless the
 treatment allocation                         IDMC requests otherwise.

 Who will see the accumulating data and       The only people who should see the accumulating data and interim analysis
 interim analysis?                            associated with safety and efficacy will be the members of the IDMC and the
                                              trial statistician.
                                              There may sometimes be a case for other members of the trial team to see the
                                              data on safety by treatment group.
                                              IDMC members do not have the right to share confidential information with
                                              anyone outside the IDMC, including the CI.

 Who will be responsible for identifying      Identification and circulation of external evidence (e.g. from other trials/
 and circulating external evidence (e.g.      systematic reviews) will be collated by the CI and the trials coordinators.
 from other trials/ systematic reviews)?

 To whom the IDMC will communicate            The IDMC will report its recommendations in writing to the Trial Management
 its report?                                  Committee, via the trial statistician or trial coordinator.

 Whether reports to the IDMC be               The IDMC should receive the report from the trial statistician at least 1 week
 available before the meeting                 the scheduled meeting.

 What will happen to the confidential         The IDMC members should store the papers safely after each meeting so they
 papers after the meeting?                    may check the next report against them. After the trial is reported, the IDMC
                                              members should destroy all interim reports.

 What recommendations will be open to             No action needed, trial continues as planned
 the IDMC?
                                                  Early stopping due, for example, a clear benefit or harm of a treatment,
                                                   futility, or external evidence
                                                  Stopping recruitment within a subgroup
                                                  Increasing the target sample size or extending follow-up
                                                  Stopping a single arm of a multi-arm trial
                                                  Sanctioning and/or proposing protocol changes
                                                  To review and agree any interim analysis plan
 How decisions or recommendations will        Every effort should be made for the IDMC to reach a unanimous decision. If
 be reached within the IDMC?                  the IDMC cannot achieve this, a vote may be taken.

IDMC Charter Template Version 1, 19/02/2010                                                                     Page 4 of 6
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Charter of the Independent Data Monitoring Committee (IDMC)


                                               Effort should be made for all members to attend. Members who cannot attend
 When the IDMC is quorate for decision-        in person should be encouraged to attend by teleconference. If, at short
 making?                                       notice, any IDMC members cannot attend at all then the IDMC may still meet if
                                               at least two members are present. It is important for the IDMC statistician to be
                                               present at all meetings, if possible. The subsequent report, including any
                                               recommended major actions, should be reviewed and approved by all

 Input from IDMC members who cannot            If the report is circulated before the meeting, IDMC members who will not be
 attend the meeting                            able to attend the meeting may pass comments to the IDMC Chair for
                                               consideration during the discussions.

 What happens if members do not                If a member does not attend a meeting, it should be ensured that the member
 attend meetings?                              is available for the next meeting. If a member does not attend a second
                                               meeting, they should be asked if they wish to remain part of the IDMC. If a
                                               member does not attend a third meeting, they should be replaced.

 To whom will the IDMC report their            By letter to the Trial Management Group within 3 weeks. A copy of this will be
 recommendations and in what form?             lodged with the trial office.

 Minutes of the meeting                        The IDMC will decide how a record of their meeting is kept.

 What will be done if there is                 If there is a serious disagreement between the IDMC and the body to which it
 disagreement between the IDMC and             reports a meeting of these groups should be held. The information to be
 the body to which it reports?                 shown would depend upon the action proposed and the IDMC’s concerns.
                                               Depending on the reason for the disagreement some confidential data might
                                               have to be revealed to all those attending such a meeting. The meeting could
                                               be chaired by an external expert who is not directly involved with the trial.

 Publication of results                        At the end of the trial there the IDMC may request to examine the final data,
                                               and comment on data interpretation

 The information about the IDMC that           IDMC members will be named and their affiliations listed in the main report,
 will be included in published trial reports   unless they explicitly request otherwise

 Any constraints on IDMC members               The IDMC may not discuss issues arising from their involvement in the trial
 divulging information about their             until at least 12 months after the primary trial results have been published.
 deliberations after the trial has been

IDMC Charter Template Version 1, 19/02/2010                                                                       Page 5 of 6
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Charter of the Independent Data Monitoring Committee (IDMC)

     Potential competing interests of Data Monitoring Committee members for [Insert trial name (and
     sponsor’s ID)]

     The avoidance of any perception that members of an IDMC may be biased in some fashion is important
     for the credibility of the decisions made by the IDMC and for the integrity of the trial.

     Possible competing interest should be disclosed via the trials office. In many cases simple disclosure up
     front should be sufficient. Otherwise, the (potential) IDMC member should remove the conflict or stop
     participating in the IDMC. Table 1 lists potential competing interests.

     Table 1: Potential competing interests
         1. Stock ownership in any commercial companies involved
         2. Stock transaction in any commercial company involved (if previously holding stock)
         3. Consulting arrangements with the sponsor
         4. Frequent speaking engagements on behalf of the intervention
         5. Career tied up in a product or technique assessed by trial
         6. Hands-on participation in the trial
         7. Involvement in the running of the trial
         8. Emotional involvement in the trial
         9. Intellectual conflict e.g. strong prior belief in the trial’s experimental arm
         10. Involvement in regulatory issues relevant to the trial procedures
         11. Investment (financial or intellectual) in competing products
         12. Involvement in the publication

     Please complete the following section and return to the trials office.

            No, I have no competing interests to declare
            Yes, I have competing interests to declare (please detail below)

       Please provide details         of      any
       competing interests:

     Name: ___________________________

     Signed: __________________________                          Date: ______________

IDMC members should not use interim results to inform trading in pharmaceutical shares, and careful consideration
should be given to trading in stock of companies with competing products.

IDMC Charter Template Version 1, 19/02/2010                                                                  Page 6 of 6
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