Continental Breakfast & Registration

8:30 am - 8:45 am

Welcome and Introduction

8:45 am - 10:00 am

Session 1 — Introduction to Clinical Research

• What is Clinical Research?
• Good Clinical Practice (GCP)
• Historical Overview
• Drug Research & Development
• Medical Device Research & Development
• Biologics Research & Development

10:00 am - 10:30 am

Morning Break

10:30 am - 12:00 pm

Session 2 — Ethical Concern and Human Subject Protection

• Ethics in Clinical Research
• Institutional Review Boards
• Informed Consent

12:00 pm - 1:00 pm

Lunch

1:00 pm - 2:30 pm

Session 3 — Regulatory Obligations

• Sponsor
• Contract Research Organizations
• Investigator
• Communication Chain

2:30 pm - 3:00 pm

Break

3:00 pm -4:30 pm

Session 4 — Research Records

• Regulatory Documents
• Source Documents
• Case Report Forms

4:30 pm - 5:00 pm

Questions and Answers, Adjourn

Continental Breakfast

8:30 am - 12:00 pm

BREAKOUT SESSION FOR CRCs

Session 5 — CRCs – Coordinating Clinical Trials

• Roles and Responsibilities
• Strategies for Success
• Sponsor Visit Preparation
• Tools to Enhance Productivity
• Query Management

8:30 am - 12:00 pm

BREAKOUT SESSION FOR CRAs

Session 6 — CRAs – Monitoring Clinical Trials

• Types of Visits
• Pre-Study Qualification
• Initiation
• Routine Monitoring
• Study Close-out
• Helpful Hints

12:00 pm - 1:00 pm

Lunch

1:00 pm - 2:30 pm

Session 7 — Adverse Experience Reporting

• What is an Adverse Experience?
• Signs vs. Symptoms vs. Syndromes
• Seriousness vs. Severity vs. Relatedness
• FDA Definitions
• Routine AE Reporting
• Serious AE Reporting
• Case Studies

2:30 pm - 3:00 pm

Afternoon Break

3:00 pm - 4:30 pm

Session 8 — Subject Recruitment: Meeting Enrollment Targets

• Recruiting Basics
• Media Pros and Cons
• Challenges to Enrollment
• Recruiting and Retention

4:30 pm - 5:00 pm

Question and Answers/Wrap-up

5:00 pm

Adjourn