ClinicalTrials.gov Guide Download PDF Version What is ClinicalTrials.gov? ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a "registry and results database." Learn more background information here. PRS System: Introduction and Requesting an Account Introduction: The ClinicalTrials.gov Protocol Registration and Results System (PRS) is used to register a clinical study or submit results information for a registered study. You must have a PRS account to register study information on ClinicalTrials.gov Request an account: Email clinicaltrials.gov@einsteinmed.org with your Name, Title, Credentials Training Access ClinicalTrials.gov staff developed the online presentations listed below to help sponsors and investigators register studies on and submit results to ClinicalTrials.gov. PDF handouts and transcripts of each presentation are provided here. Contact clinicaltrials.gov@einsteinmed.org with any further questions you may have. Determine if a Study is an “Applicable Clinical Trial” (ACT) Use this checklist to evaluate whether a clinical trial or study is an applicable clinical trial (ACT) If you answered “yes” to all 4 questions, and the study was initiated on or after January 18, 2017, the trial would meet the definition of an ACT that is required to be registered under 42 CFR 11.22. For NIH and ICMJE definitions of Clinical Trial: Refer to this checklist Instructions for Registering a Study Step 1: Determine who is responsible for registering the clinical study and which Protocol Registration and Results System (PRS) account should be used. Step 2: Learn about submission requirements ClinicalTrials.gov allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to: Any applicable human subject or ethics review regulations (or equivalent) Any applicable regulations of the national or regional health authority (or equivalent) Step 3: Log in to Protocol Registration and Results System Step 4: Enter the required and optional data elements Step 5: Preview, inspect, and release (submit) the record Further guidance and instructions available here on ct.gov PRS System Quality Control Review Criteria for Protocol Registration Einstein’s Office of Human Research Affairs Instructions for Registering your Trials & Tips for Registering Studies Required Updates and Reporting Timeline In general, clinical trial registration information submitted to ClinicalTrials.gov must be updated not less than once every 12 months. The regulations further require that some data elements be updated more rapidly. In addition, if a protocol is amended in such a manner that changes are communicated to human subjects in the clinical trial, the regulations require that updates to any relevant clinical trial information be submitted not later than 30 calendar days after the protocol amendment is approved by a human subjects protection review board. Quick Reference Table for Clinical Trial Registration Data Elements that Require More FrequentUpdating Consent Form Upload Requirement The revised Common Rule (45 CFR 46.116(h)) effective January 19, 2018, requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form used in enrolling participants be posted on a publicly available Federal website within a specific time frame, such as clinialtrials.gov and regulations.gov. Further guidance and instructions available here Einstein’s Office of Human Research Affairs Clinicaltrials.gov Informed Consent Form Requirement Instructions for Updating Record Responsible Parties should update their records within 30 days of a change to any of the following: Recruitment Status (for each site) (not yet recruiting, recruiting, active, not recruiting, completed, etc.) Overall Recruitment Status (clinical study as a whole if multi-site) Completion Date (The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome) Other changes or updates to the record, such as protocol amendments, must be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record. Tutorial: Updating a Study Record Einstein’s Office of Human Research Affairs Instructions for Updating a Study Record Instructions for Results Reporting The Responsible Party must submit summary results no later than 12 months after the date of final data collection for the pre-specified primary outcome measure. Results Reporting Elements: Participant Flow, Baseline Characteristics, Outcome Measures & Statistical Analyses, and Adverse Events Templates, definitions, tutorials and further instructions available here NIH Requirements for Registering and Results Reporting PRS System Quality Control Review Criteria for Results Reporting Tutorial: Outcome Measures and Statistical Analysis in the Results Module Resources Regulations: Section 801 of the Food and Drug Administration Amendments Act (FDAA 801) Final Rule For Clinical Trials Registration and Results Information Submission (42 CFR Part 11) Institutional Policy: Montefiore Einstein Clinical Trials Registration and Results Reporting Policy Other Support Materials: Tutorial: Registration and Results Reporting Clinical Trials Support Materials Page Einstein Office of Human Research Affairs- Clinicaltrials.gov FAQ Institutional PRS Administrator ClinicalTrials.gov@einsteinmed.org 718-430-2643