The Chief Investigator is responsible for establishing the appropriate study management and oversight groups for their study. What format these oversight groups should take will need to be appropriate to the study type (whether a clinical trial or not), size (whether multiple site) and associated risks (as assessed by the Chief Investigator and the sponsor at the time of the sponsorship request). The most common oversight groups and committees TMG, TSC and IDMC are summarised below.
For clinical trials, the study management and oversight arrangements should be defined in the protocol and detailed in the study-specific monitoring plan (agreed with Noclor prior to study activation).
- Trial Management Group (TMG)
It is expected that most clinical trials will establish a Trial Management Group (TMG).
The TMG should include the Chief Investigator, Trial Manager and other members of the study team responsible for the day-to-day management of the trial.
The Chief Investigator may able to perform the functions of a TMG in a small study.
The requirement for TMG meetings should be documented in the protocol and detailed (i.e composition and frequency of meetings) in the study specific monitoring plan
The TMG should monitor all aspects of the progress and conduct of the trial.
The Chief Investigator should retain copies of all meeting agendas, papers and minutes in the Study/Trial Master File (S/TMF).
Copies of TMG meetings minutes should be sent to the Noclor Sponsor Representative (sponsor) to ensure sponsor oversight.
- Trial Steering Committee (TSC)
For larger more complex clinical trials a Trial Steering Committee (TSC) should be established (this can be instead of or in conjunction with a TMG).
The TSC should have independent members – appointment of an independent Chairperson is advisable (not mandated).
A TSC charter should formalise the membership, responsibilities and reporting mechanisms of the committee.
The TSC should make recommendations/key decisions during the trial to the TMG (if relevant), Chief Investigator and sponsor.
The Chief Investigator should retain a signed copy of the TSC Charter and all meeting agendas, papers and minutes in the Study/Trial Master File (S/TMF).
Copies of TSC meetings minutes should be sent to the Noclor Sponsor Representative (sponsor) to ensure sponsor oversight.
- Independent Data Monitoring Committee (IDMC)
For clinical trials with unknown or uncertain risks, it is strongly recommended to establish an Independent Data Monitoring Committee (IDMC).
The IDMC should be completely independent of the Investigators and the funder/sponsor.
The requirements for IDMC should be considered in the protocol and will be reviewed by the sponsor during the initial risk assessment.
An IDMC Charter should formalise the membership, responsibilities and reporting mechanisms of the committee.
The IDMC should advise the TSC, Chief Investigator and sponsor on safety issues.
Non-confidential minutes (or recommendations/reports) should be provided by the IDMC Chair to the TSC, Chief Investigator and sponsor (Noclor Sponsor Representative).
The Chief Investigator should retain a signed copy of the IDMC Charter and all meeting correspondence in the Study/Trial Master File (S/TMF). A file-note detailing the location of the IDMC confidential minutes should also be placed in the S/TMF (until the study is prepared for archive at this point the IDMC minutes will be filed in place of the file-note).