Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov

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.

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.

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.

This course was updated in December 2019. Important changes include updated quality control and posting procedures for applicable clinical trials (effective January 2020) and the ability to export partial protocol registration information from NIH study management system and upload into PRS.

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).

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

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.

Yes. All video lectures have captions available.

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

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.

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