|
Home |
|
Members and Staff |
|
Key Elements |
|
Stratification Guide |
|
FAQs |
|
Clinical Research Forms |
|
Frequently Asked Questions |
|
What research protocols are subject to review by the program? How will I be notified that my research is selected for monitoring? Does the Principal Investigator need to be present for the entire process? Who will receive the results of the monitoring activity?
What research protocols are subject to review by the program? All open research protocols involving human participants at the Medical School and the Danforth Campus are subject to review by the program. Research subject to monitoring by other mechanism will not be reviewed except in for-cause circumstances.
How will I be notified that my research is selected for monitoring? The Principal Investigator will be notified in writing that a particular study has been selected for review. The monitoring staff will then call to make a mutually agreeable appointment for on-site review, typically within 3-4 weeks of notification.
Does the principal investigator need to be present for the entire process? After a short general discussion of the research protocol, the analyst will need a place to work and access to the requested files. Someone who is able to answer questions (either the PI or research coordinator) should be available by phone.
What will be reviewed? All of the regulatory documents related to the study will be reviewed on-site. In addition, the analyst will request specific subject records (the number will depend on the accrual to date). Review of subject records will include the informed consent process, the inclusion/exclusion criteria, the records of the research intervention and any follow-up. Adverse event and unexpected occurrence records will be reviewed. The analyst may contact subjects who have participated in the study in order to review their understanding of the consent process, the research project and their impressions of participation in the research process.
Who will receive the results of the monitoring activity? The Faculty Committee will review the results of the analyst’s report. Minor concerns will be addressed with the Principal Investigator and research staff. Serious concerns will be reported to the Vice Chancellor for Research. Educational efforts to address general concerns will be developed as they arise. |
