This section details how study teams should complete Sections 32-1 (“Data Safety and Monitoring Plan - AE Reporting”) and 32-2 (“Data Safety and Monitoring Plan - Monitoring the Study”) for a minimal-risk study involving an NSR device.
At a minimum, the following should be considered by the study team and the IRBMED (selected questions within Sections 32-1 and 32-2): Screenshots from eResearch Section 32 are included in the references below.
- Section 32-1 (AE reporting) should indicate an AE reporting plan (IRBMED standard or study-specific) to report AEs to IRBMED. Note that identifying and reporting AEs is also part of the monitoring requirements.
- Section 32-2 (“Monitoring the Study”) should include details about any additional monitoring activities. In the current eResearch application, completing Section 32-2 is required when Section 32-1 is triggered.
- In Question 32-2.1, the study team should indicate that the study team will conduct periodic assessments. They should select a timeframe that is appropriate and realistic from the available options. Generally, quarterly or semi annual, or annual assessments is appropriate for low-risk NSR studies; the weekly or monthly assessments should be carefully considered.
- In Question 32-2.2, the study team may select the "No Additional Monitoring Required” option. Do not select any other options in 32-2.2 unless there are specific plans to do additional monitoring; any selection of additional monitoring within 32-2.2 may be required as the study progresses.
NOTE: The FDA recommends a risk-based monitoring approach and practices to ensure appropriate oversight of clinical investigations. This means that minimal-risk clinical investigations involving a device determined to be NSR generally do not require a formal data safety monitoring board (DSMB) or an independent monitor. However, each IRBMED board should determine what constitutes an appropriate plan based on the risk proposed by the study (this is in accordance with the FDA guidance on monitoring).
- When selecting the "No Additional Monitoring…" option in 32-2.2, do not complete the sub-questions (32-2.2.1, 32-2.2.2, 32-2.2.3, and 32-2.2.4).
- In 32-2.3 (“Submitting Monitoring Reports”), select "IRB," as this is a required question. In most cases, if Section 32-2 is completed as instructed above, there will not be any monitoring reports to submit to IRBMED. See Section III below for information on what the study teams are required to report to IRBMED.
Reminder for study teams and IRBMED: Ensure that there is no conflicting information in Section 32-2 regarding monitoring. For example, do not indicate one timeline in 32-2.1 and another in other places.