GXP2165 Management of Externally Sponsored Studies

GXP2165 Management of Externally Sponsored Studies

Description:

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

Author:

GXP2165 Management of Externally Sponsored Studies
Dr. Masaab Bashir
Dr. Massab Bashir holds a Ph.D. in Microbiology and Immunology. Dr. Bashir leads a medical and research writing team of qualified doctors. Massab and his team have over five years of research writing experience in the medical, biotech, and pharmaceutical fields. To date, Dr. Bashir and his team have successfully completed more than 500 projects

General info:

Duration:

1 hour

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

Reviews:

Learning to draft a winning proposal for financing is an absolute win for the team. We have also learned about the management of sponsored studies for credibility and accountability.

Regina C

-

Training Director

You want to discover this course ?

GXP2165 Management of Externally Sponsored Studies

Quote request