Management of Externally Sponsored Studies

Clinical trials and other research exploits are extremely capital-intensive making it difficult for research institutes and members of academia to run them on their own. Hence, most of the major research being done in the pharmaceutical industry is done in partnership with sponsors that can provide the needed capital. This course walks one through the various kinds of sponsorship options available. It also teaches the basics of drafting a standard proposal for grants and other research aids.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: Study Proposal

• Proposal Development
• Basic Proposal Content
• Title Page
• Table of Contents

Lesson 2: Proposed Budget

• Budget Justification
• Direct Costs
• Salaries and Wages
• Permanent Equipment
• Supplies
• Travel
• Publication Costs
• Other Direct Costs
• Indirect Cost (Facilities and Administrative)

Lesson 3: Management Plan

• Components of Typical Management Plan
• Personnel Roles and Responsibilities Involved in The Research Project
• Volunteers Participation in The Project
• Collaborations
• Project Timeline
• A Management Plan and Donor

Lesson 4: Management of an Award from Donor

• Research Proposal Acceptance
• Composition of Approved Award Notice
• PI Responsibilities
• Records
• Post Award Modification in the Project
• Budget Revisions

Lesson 5: Research Ethics and Compliance

• Institutional Review Board (IRB)
• Conflicts of Interest
• Individual Informed Consent
• Research Integrity and Misconduct

Lesson 6: Risk Assessment and Risk Management

• Pre-award
• Post-award
• Acknowledgement of Donor
• The Privacy of the Research Project

Conclusion

Glossary

Quiz