GoingToMeet

This is an introductory course designed for understanding of concepts, strategies and processes of HRQOL. Areas Covered in the Seminar:

Defining health-related quality of life (HRQOL).

Why do HRQOL research?

Generic vs disease-specific instruments.

Examples of questions and questionnaires.

Scoring questionnaires.

Psychometric properties—reliability/reproducibility,

validity, and responsiveness.

When to do HRQOL in the drug development process.

Monitoring issues.

Statistical issues.

Proper placement in the protocol and study report.

Labeling/Package Insert Issues

FDA Guidance.

References/Bibliography.