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All study investigators have agreed to meet on a monthly basis to monitor trial progress and procedure.
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The Management Team will monitor the trial progress status and data by face-to-face and/or telephonic contact with each of the sites every month.
The committee shall consist of three people: Yutaka Natsumeda, M.D., Satoshi Inoue, M.D., and Yukiharu Yamaguchi, Ph.D. The Management Team will monitor the trial progress status and data by face-to-face and/or telephonic contact with each of the six sites every month.
Throughout the trials, a Data Safety Monitoring Board (DSMB) will be involved in monitoring the trials' progress.
The trial progress is monitored by an independent Data Monitoring and Ethics Committee DMEC and Trial Steering Committee TSCTSC).
The trial progress is monitored by an independent Trial Steering Committee.
Participants will be monitored as the trial progresses with questions relating to mood embedded within the respective internet programs in Week four and Week eight.
Fig. 1 CONSORT diagram showing trial progress.
Trial progress and participant recruitment.
To ensure the timeliness of trial progress, the integrity of data, and the safety of trial participants, IAVI needed to ramp up training, and bring trial monitoring in-house.
To ensure investigators are following the protocol, complying with regulatory and Good Clinical Practice (GCP) standards, and collecting and reporting quality data, sponsors of clinical trials monitor the progress of clinical trials performed by the investigators during the clinical trial.
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