9 Data and Safety Monitoring Plan

This section is required when research involves more than Minimal Risk to subjects as defined in “HRP-001 SOP- Definitions.”

Minimal Risk is defined as the probability and magnitude of harm or discomfort anticipated in the research that are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For research involving prisoners, Minimal Risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

Please complete each section below if the research involves more than minimal risk to subjects or indicate not applicable.

9.1 Periodic evaluation of data

Describe the plan to periodically evaluate the data collected regarding both harms and benefits to determine whether subjects remain safe.

Not applicable.

9.2 Data that are reviewed

Describe the data that are reviewed, including safety data, untoward events, and efficacy data.

Not applicable.

9.3 Method of collection of safety information

Describe the method by which the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls and with subjects).

Not applicable.

9.4 Frequency of data collection

Describe the frequency of data collection, including when safety data collection starts.

Not applicable.

9.5 Individuals reviewing the data

Identify the individuals who will review the data. The plan might include establishing a data and safety monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor.

Not applicable.

9.6 Frequency of review of cumulative data

Describe the frequency or periodicity of review of cumulative data.

Not applicable.

9.7 Statistical tests

Describe the statistical tests for analyzing the safety data to determine whether harms are occurring.

Not applicable.

9.8 Suspension of research

Describe any conditions that trigger an immediate suspension of research.

Not applicable.