How Does ClinicalTrials.gov Advance Clinical Trial Transparency?
DescriptionThis session covers the aims of ClinicalTrials.gov, discusses the quality control (QC) review process, and describes how to find studies on ClinicalTrials.gov.
To learn more about the topics in this video, visit these resources:
- ClinicalTrials.gov Webinar: Updated Quality Control and Posting Procedures (new window) : View a webinar that provides information about the QC review process and examples of QC review comments. (Source: National Library of Medicine)
- ClinicalTrials.gov Protocol Registration Quality Control Review Criteria (new window) : Read an overview of the ClinicalTrials.gov registration QC review process, and view specific criteria intended to help you prepare study records with protocol registration information. (Source: ClinicalTrials.gov)
- ClinicalTrials.gov Results Quality Control Review Criteria (new window) : Read an overview of the ClinicalTrials.gov results QC review process, and view specific criteria intended to help you prepare study records with results information. (Source: ClinicalTrials.gov)
- Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19) (new window) : Read responses to questions from responsible parties about the submission of clinical trial information to ClinicalTrials.gov during COVID-19. (Source: ClinicalTrials.gov)
- Example Studies for Results Data Entry (new window) : View study design examples posted on the ClinicalTrials.gov Training Materials page. (Source: ClinicalTrials.gov)
- Hot Off the PRS! (new window) : Sign up for the Hot off the PRS! email bulletin to get timely updates about the PRS sent to you. (Source: NLM, National Institutes of Health)
- Clinical Trials (new window) : Read about the International Committee of Medical Journal Editors (ICMJE) policies regarding clinical trial registration and data sharing statements for journal submissions. (Source: ICMJE)
- Clinical Trials Registration and Results Information Submission (new window) . Read the HHS final rule on clinical trial registration and results information submission. (Source: FederalRegister.gov)
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (new window) : Read about the purpose of this policy, and find the effective date and contact information for inquiries about NOT-OD-16-149.
- Final Rule (42 CFR Part 11) Information (new window) : Read general information about the Final Rule, including updates that provide more details on data submission requirements such as the formatting of certain types of clinical trial information as required by the Final Rule. (Source: ClinicalTrials.gov Protocol Registration and Results System)
- Submit Studies to ClinicalTrials.gov PRS (new window) : Find resources about the Protocol Registration and Results System Web-based data entry system used to register clinical studies and submit results information for those studies. (Source: ClinicalTrials.gov)
- Clinical Trial Requirements for Grants and Contracts (new window) : Find key resources and tips for applicants and grantees on a series of NIH initiatives to enhance the accountability and transparency of clinical trial research throughout the clinical trial life cycle, from concept to results reporting. (Source: NIH Grants & Funding)
- FDA's Role: ClinicalTrials.gov Information (new window) : Read about the U.S. Food and Drug Administration's (FDA) role in relation to ClinicalTrials.gov. (Source: FDA)
Last Reviewed: September 10, 2021