GXP2099 Registration of Trials on clinicaltrials.gov

GXP2099 Registration of Trials on clinicaltrials.gov

Description:

Clinical trials commit immensely to the knowledge pool that facilitates evidence-based healthcare practice. Sometimes, the trials are for novel drug substances, and other times they seek to test novel applications of existing drug substances. As these trials contribute to a global pool, they must be registered properly on a database where all the information concerning them can be accessed by as many who need it. In this course, you learn about the responsibilities of sponsors. Researchers, and Journal Publishers in ensuring that clinical trials are registered even before they are commenced. You will also learn about the ICTRP and WHO criteria for trial registration.

 

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: Sponsor and Researcher/Investigator Responsibilities

 

  • Sponsor Responsibilities
  • Investigator/Researcher Responsibilities

 

Lesson 2: Approval and Reporting System

 

  • Approval System
  • Reporting

 

Lesson 3: Registration

 

  • WHO Criteria
  • Who Needs to Register?
  • Timing to Register on ClinicalTrials.gov?
  • What You Should Do After Registration?

 

Lesson 4: The Standards, Intellectual Property (IP) and Data, Unambiguous Identification

 

  • Content
  • Intellectual Property (IP) and Data
  • Unambiguous Identification

 

Lesson 5: Quality, Validity, and Accessibility

 

  • Quality and Validity
  • Accessibility

 

Lesson 6: Data Interchange Standards and Audit

 

  • Data Interchange
  • Implementation of Standards
  • Audit

 

Conclusion

 

Glossary

 

Quiz

 

Author:

GXP2099 Registration of Trials on clinicaltrials.gov
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:

A major take home for the team; an ideal registration document must be valid, accessible, and of quality. My team is better informed on the importance of registration to the credibility of clinical trials.

Regina C

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Training Director

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GXP2099 Registration of Trials on clinicaltrials.gov

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