You (the Investigator) are responsible for conducting research as approved by Castle IRB. Once a study begins, certain events must be reported to Castle IRB to ensure the ongoing safety of participants and to satisfy regulatory requirements. These include the following:
- Amendments (changes in research): any proposed changes in research or study materials, prior to implementing changes except to remove apparent, immediate hazards to research participants. This includes changes in the investigative team’s financial conflicts of interest and licensure.
- Continuing Review/Progress Reports: periodic (typically annual) review of study progress to ensure it is safe to continue.
- Reportable Events: events related to safety or compliance, including protocol deviations, noncompliance, unanticipated problems, participant complaints, breaches in privacy or confidentiality, and study or enrollment halts due to subject safety concerns or loss of resources needed to conduct the trial safely.
- Closures: closing of IRB oversight, which could include early termination of studies or a study site.
More information is found in the Castle IRB Investigator Guide. Submission forms can be found on the How to Submit page.