Study Interim Visits‌ Sample Clauses

Study Interim Visits‌. The first monitoring visit after site activation normally will be conducted when the first few participants have been enrolled at the site. Since study monitoring is based on the rate of patient enrollment, the number of patients enrolled at each site, and a number of other variables, monitoring will be adjusted to reflect the needs of the study and the participating sites. Prior to the site visit, the study monitor will review the protocol for critical aspects of the study for monitoring compliance. The study monitor will also review outstanding queries and missing forms, unresolved issues from the previous site monitoring visit (if applicable), study signature log, regulatory checklist, and device accountability log, as well as any other project specific documents. The study monitor will review demographic and eligibility criteria source documentation to ensure that all participants who have been enrolled in the trial were eligible. All data or events that: 1) are critical to the reliability of the study findings, specifically those data that support primary and secondary endpoints, 2) are critical to the safety and ethical treatment of study subjects, or 3) affect the integrity of critical data will be 100% source verified. If possible, identified discrepancies will be corrected by the site staff during the visit, but may be corrected afterwards. Documentation will also be reviewed for AEs. Any protocol deviations or unreported AEs will be brought to the attention of the coordinator and/or investigator for immediate action. The study documentation to be kept in the study regulatory binder will also be reviewed routinely. Informed consent forms will be reviewed to verify that the appropriate IRB/IEC approved consent has been signed by both patient and the person administering the consent, dated, and properly witnessed if this is required by the form used at the site. Test articles will be reviewed at each visit and compared to the test article accountability log. The study monitor will be responsible to review the delivery and the inventory records to ensure that the quantity of the study product was shipped, received or returned as specified. The test article records will be compared with the participant records to ensure that proper device was received. The monitor will also verify that the test article is kept in a secure locked place. The study monitor will conduct a summary meeting with the study investigator and/or the study coordinator to discuss ...
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Related to Study Interim Visits‌

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