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Case 1:17cv00099JKB Document 6081 Filed 04/13/23-Page 2 of 49 Row 1SixthYear Monitoring Plan2General Notes: This Sixties Monitoring Plan contains all requirements, milestones, deliverables, and deadlines

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How to fill out data and safety monitoring

01

Establish a data and safety monitoring committee or board

02

Develop a data and safety monitoring plan

03

Identify the data and safety monitoring indicators

04

Implement data collection and reporting processes

05

Regularly review and analyze the data

06

Take action based on the findings to ensure the safety of participants

Who needs data and safety monitoring?

01

Clinical trials

02

Medical research studies

03

Drug development projects

04

Biomedical studies involving human subjects

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What is data and safety monitoring?

Data and safety monitoring involves regularly reviewing and assessing data from a study to ensure the safety of participants and the integrity of the study results.

Who is required to file data and safety monitoring?

Researchers conducting clinical trials and studies involving human subjects are usually required to file data and safety monitoring.

How to fill out data and safety monitoring?

Data and safety monitoring forms are typically filled out by the principal investigator of the study and submitted to the appropriate regulatory bodies.

What is the purpose of data and safety monitoring?

The purpose of data and safety monitoring is to ensure the safety of study participants and the validity of the study results.

What information must be reported on data and safety monitoring?

Information such as adverse events, protocol deviations, and data quality must be reported on data and safety monitoring forms.

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