NINDS/NIH Policies for Monitoring Clinical Research:

NINDS and NIH has developed policies and guidelines for monitoring clinical trials. The following websites provide information that may be useful in the conduct of a clinical research project:

Data Safety Monitoring

• NINDS Extramural Guidelines for Monitoring Patient Safety in Clinical Trials
• NIH Policy Concerning Data and Safety Monitoring
• Further Guidance on Data and Safety Monitoring for Phase I and II Trials
• Guidance on Reporting Adverse Events to IRBs for NIH-supported Multicenter Clinical Trials
• Regarding Letters or Notices from the Food and Drug Administration (FDA)

Certificate of Confidentiality

• NIH Announces Statement on Certificates of Confidentiality

Human Subject Protection

• Responsible Conduct of Research
• NIH Course on Human Research Protections Goes Online (press release)
• Human Research Protections Course

Conflict of Interest

• Conflict of Interest web site

Race and Ethnicity

• NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research

Grant Applications

• PHS 398 Requirements