Examples of IDMC Charter in a sentence
These members will be independent of the trial and familiar with the methodology of oncology trials.The mission and procedures for the IDMC will be detailed in the IDMC Charter which will be issued by the study coordination team.
After unblinding of the study, the statistical analyses will be performed by the study evaluation team of the CRO (Aptiv Solutions).Details on the interim analysis for futility including the pre-specified stopping rule have been agreed with the IDMC and are laid down in a separate document attached to the IDMC Charter 28.Details on the interim analysis of overall survival including information about data collection are found in section 11.6.2.No early stopping for efficacy reasons is planned.
Further details of IDMC functioning, the procedures for interim analysis and monitoring are provided in the IDMC Charter.
Full details of the IDMC membership and remit can be found in the IDMC Charter.
The IDMC’s objectives and operational details were defined in a separate document (IDMC Charter) which was finalized before the first subject was screened in the study.
An IDMC Charter will be drawn up that describes the membership of the IDMC, relationships with other committees, terms of reference, and decision-making processes (with a description of stopping rules and/or guidelines, if any).
IDMC members will be required to sign up to the remit and conditions as set out in the IDMC Charter which will be filed in the TMF.
Full details of the IDMC procedures and processes can be found in the IDMC Charter.
The IDMC is advisory to the TSC and can recommend premature closure of the trial to the TSC.IDMC members will be required to sign a IDMC Charter, which describes the committee’s responsibilities and requires any potential conflicts of interest to be declared.
For clarity, the IDMC Charter will specify the number of members of the IDMC, the qualifications of such members, the experience of the chairman of the IDMC, details regarding open and closed sessions, including who can attend any such sessions, and information that the IDMC may share with the Parties, including that efficacy will not be disclosed to either Party until the IDMC has approved such data.