Monitoring and safety
As in our previous studies [IDMC’s responsibilities are to review safety data on an on-going basis, recommend that the clinical study be stopped early if there is strong evidence that the investigational medicinal products are harming patients, and make recommendations regarding modification of the study if there is strong evidence that such change would substantially contribute to the well-being of patients. The IDMC will independently make its recommendations for continuation or termination of the trial to the appropriate Sponsor contact. The IDMC will maintain records of all its meetings and activities related to the study. These records will remain confidential until completion of the final analysis at which time they will be forwarded to the Sponsor for appropriate filing. Members will be aware of data management and quality control procedures to be confident the data are timely, accurate and complete.