Management of Externally Sponsored Studies

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Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course :ย 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

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:

Bashir
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

Reviews:

5/5
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USD: United States (US) dollar ($)

$48.00 $60

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