Registration of Trials on clinicaltrials.gov

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