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The research team will monitor the integrity of trial data.
The integrity of trial data will be monitored by regularly scrutinizing data sheets for omissions and errors.
Hence, it was necessary for ACRIN to design unique audit procedures to insure the integrity of trial data.
The integrity of trial data will be ensured by regularly monitoring of data sheets for omission and errors.
The integrity of trial data will be monitored by regularly scrutinising data files for omissions and errors.
The integrity of trial data will be monitored by regularly scrutinising data sheets for omissions and errors.
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An independent data monitoring committee׳s (IDMC׳s) duty is to ensure that the interests of the patients entered in the trial are being well served (i.e., the risk-benefit ratio is appropriate) and that the scientific integrity of the trial is maintained during the interim between trial initiation and trial completion.
To ensure the integrity of the trial's procedures, all study staff and clinical trial or research centre nurses will undergo specific training and quality assurance assessments throughout the study.
327 In addition, it is important to state who will see the outcome data while the trial is ongoing, whether these individuals will remain blinded (masked) to study groups, and how the integrity of the trial implementation will be protected (eg, maintaining blinding) when any adaptations to the trial are made.
In [ 1] adaptive designs are defined as: "...a clinical trial design that allows adaptations or modifications to aspects of the trial after its initiation without undermining the validity or integrity of the trial.
In addition, successful implementation of an adaptive design trial relies on establishment of a trustworthy logistics model that ensures integrity of the trial conduct.
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