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.
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).
Full details of the IDMC procedures and processes 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.
Full details of the IDMC membership and remit can be found in the IDMC Charter.
Only those who have been accepted in the military or an institution of higher learning can leave school before they are 18 years old.
An Independent Data Monitoring Committee (IDMC) will be formed to evaluate the outcome and safety and tolerability issues that may arise during the conduct of the study according to the IDMC Charter.
They will do this by monitoring the study periodically for safety, study progress, and protocol compliance, as well as assessing the risk / benefit of the trial.Independent Data Monitoring Committee meetings will be held as per separate IDMC Charter, approximately every 6 months throughout the blinded trial phase.