Principal Investigator’s Guide to ClinicalTrials.gov

The module describes the learning objectives for the course. It lists the information collected by ClinicalTrials.gov, identifies who benefits from this information, and outlines the implications of ClinicalTrials.gov for study management.

Recommended Use: Required
ID (Language): 22432 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

The module describes U.S. regulations and policies governing clinical trial registration and results disclosure. It explains the key purposes of ClinicalTrials.gov and identifies the stakeholders who benefit from the website’s information. The module also discusses the international context of clinical trial registration.

Recommended Use: Required
ID (Language): 22433 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

The module outlines the relationship between the PRS and the public ClinicalTrials.gov interface. It describes how to obtain an account on the PRS and details the roles and workflows within it. The module also explains the meaning of integrated feedback prompts generated by the PRS.

Recommended Use: Required
ID (Language): 22434 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

The module describes how to create a new protocol registration record and how to enter data into it. It outlines which sections of the record need periodic updates, and how to complete them. The module identifies which sections of the protocol record are automatically incorporated into the result summary and explains why learners must ensure these are up to date before creating a new result record.

Recommended Use: Required
ID (Language): 22435 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

The module describes how PRS uses tables for Result Summary input and indicates which protocol data may be or will be transferred to the Result Summary. It explains how to create a new Result Summary and how to complete the scientific and administrative sections.

Recommended Use: Required
ID (Language): 22436 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

The module explains how to estimate the time required to enter and update protocol registration and results summary information. It describes several tips to help investigators keep records up to date. The module also presents examples of potential penalties for compliance failure.

Recommended Use: Required
ID (Language): 22437 (English)
Author(s): Tim Bacon, BA - Medicine in Practice