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Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov

This course provides a video-enhanced guide to compliance with the FDAAA Final Rule and NIH Policy on clinical trial disclosure in ClinicalTrials.gov.

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About this Course


Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov is a video-enhanced guide to compliance with the FDAAA Final Rule and NIH Policy on clinical trial disclosure in ClinicalTrials.gov.

This innovative course guides learners through critical parts of the regulations and provides a step-by-step guide to data entry, thus helping organizations avoid the risk of significant civil monetary penalties or loss of NIH grant funding.

This course was created by Tim Bacon, BA and peer reviewed by experts.

Language Availability: English

Suggested Audiences: Clinical Researchers, Clinical Research Coordinators, Investigators, Sponsors

Organizational Subscription Price: $650 per year/per site
Independent Learner Price: Coming soon


Course Content


Overview: Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov New Content

Provides an overview of the video-enhanced course, including the importance of viewing the video lectures. This module also provides a reference table listing all videos by module and key terms used.

Recommended Use: Required
ID (Language): 19112 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

Transparency in Clinical Research: ClinicalTrials.gov in Context New Content

Discusses the evolution of clinical trial registration and summary results information submission requirements, and the importance of transparency in clinical research. Identifies regulations and policies for clinical trial disclosure and the benefit of public registries to diverse stakeholders.

Recommended Use: Required
ID (Language): 19113 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

Protocol Registration and Results System (PRS): Structure, Access, and Roles New Content

Provides a video-enhanced overview of the structure, access, and user roles in the Protocol Registration and Results System (PRS) interface (the data entry system for the public ClinicalTrials.gov website). Describes data entry access and workflows, including review, revision, and record release.

Recommended Use: Required
ID (Language): 19115 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

Applicable Clinical Trials (ACTs) and Responsible Party (RP) Identification New Content

Reviews U.S. regulatory and policy requirements for disclosing clinical trials, identifies which studies must be registered and by when, and describes who is responsible for the trial registration. The module covers both prospective protocol registration and summary results information submission.

Recommended Use: Required
ID (Language): 19114 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

Protocol Registration New Content

Gives detailed, practical video lectures that provide guidance on how to enter data into each section of the protocol registration record. Provides strategies on preparing records for quality control review by the ClinicalTrials.gov team and responding to comments.

Recommended Use: Required
ID (Language): 19116 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

Summary Results Information Submission New Content

Provides detailed instructions for entering summary results information into the results section of the PRS with actual hands-on data entry videos. This module also discusses how the summary results information submission will be reviewed by the ClinicalTrials.gov team for quality control criteria.

Recommended Use: Required
ID (Language): 19117 (English)
Author(s): Tim Bacon, BA - Medicine in Practice

ClinicalTrials.gov and Informed Consent New Content

Reviews clinical trial registry disclosure language requirements in the informed consent form (ICF) for clinical trials subject to FDA regulations and NIH Policy. Discusses how to post a consent form in the PRS to comply with Common Rule consent posting requirements.

Recommended Use: Required
ID (Language): 19118 (English)
Author(s): Tim Bacon, BA - Medicine in Practice


FAQs


How long does this course take to complete?

This course consists of seven modules that contain detailed video lectures, written content, images, and supplemental materials (such as FLEXlinks). Learners may complete the modules at their own pace. Each module varies in length, and learners may require different amounts of time to complete the module based on their familiarity and knowledge of the topic. While most modules are approximately 30 to 45 minutes in length (which means this course may take learners around three hours to complete), the amount of time it takes to complete the course may vary because learners may also choose to focus on protocol registration, results disclosure, or both as they review the modules.

Who should take this course?

Individuals should take this course if they are responsible for registering protocols and/or submitting summary results information in ClinicalTrials.gov. This can be the sponsors, designated responsible parties, investigators, research staff, clinical research coordinators, or anyone assigned these tasks to complete.

How often should learners take this course?

This course can be used initially to familiarize learners with the basic requirements and processes, and then the topic-focused modules can be accessed as-needed to refresh. It would be recommended to complete this course once, and then as needed.

What are the standard recommendations for learner groups?

This course is designed with flexibility to address different learner group needs.

The recommended set-up is to set all modules as “Required” for initial completion. This would prepare learners to enter protocol registration information and submit summary results information into the PRS system.

For refresher training, it is recommended to set all modules as “Elective” so learners may choose which modules to complete. This set-up would accommodate learners who are returning to the course to receive training relevant to them (for example, learners who are preparing to submit summary results information and only want to complete the module Results Summary Disclosure).

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

What are the advantages of the video micro-learning offered in this course?

Entering and maintaining regulated data in ClinicalTrials.gov requires both a detailed knowledge of applicable regulations and a confident understanding of how to enter data into the PRS interface. Both needs are more effectively met with the hands-on approach provided in the video lectures that comprise the bulk of this course’s learning content.

Do video lectures have captions?

Yes. All video lectures have captions available.

Do learners need to view all the videos?

Yes. Learning content is contained within video lectures. It is important to view the videos because the quizzes are based on the video content.

Which regulations and policies does this course cover?

This course focuses on: Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR 11), and the Final Rule’s complementary National Institutes of Health (NIH) Policy on the Dissemination of NIH-funded Clinical Trial Information. While similar regulations exist for trial registration in many parts of the world, they are outside the scope of this course.

If a learner completes the course, can they return to review modules?

Yes. If a learner completed modules and video lectures, they can return at any time to review the completed modules.