Data & Safety Monitoring of Clinical Trials in Intervention and Drug Abuse Services Research

Overview

Benefits DSM

Benefits DSM

Benefits of DSM

Why Does NIH Require DSM in Behavioral Research?

Diversity in HS Clinical Research

DSM Issues in HSR

Why DSM make sense for HSR

Differences in DSM for
3 Types of Research

IPV and HIV Among Drug-Involved Women

HIV Prevention Messages

HIV Risk & IPV Among
Drug-Involved Women

Project WORTH
AIMS of The Study

Design

Project WORTH

Demographics

Safety Monitoring

Safety Concerns for Women Participating in HIV Research

Demographics Relevant to Safety Monitoring

  Safety in HIV Intervention Research:
Monitoring Subject Behavior

Safety in HIV Intervention Research:
Monitoring Partner Behavior

Adverse Event (AE)

Serious Adverse Event (SAE)

FDA-defined SAEs

Project Worth Adverse Events
(Anticipated)

Reported Adverse Events

Reported Serious Adverse Events

Safety Procedures During
 Intervention Implementation

Safety Quality Control Procedures

Safety Q&A Procedures

Data Monitoring

Challenges

Data Monitoring

Issues Relevant to Data Monitoring

Data Monitoring Procedures

Data Q&A Procedures

Federal Resources

Books & Articles

Other Resources

Questions