Plain Language Guide to Write a Brief Summary - ClinicalTrials.gov
ClinicalTrials.gov study records include a Brief Summary of the clinical trial. A Brief Summary written in plain language helps the general public more easily understand a study’s goal, research questions, …
Checklist for Lay Brief Summaries Added to ClinicalTrials.gov
Sep 28, 2022 · See the document now for the complete checklist, tips for testing the summary, and additional writing resources. This document provides study managers with best practices for writing …
An initial results submission requires clinical trial results (including statistical analyses, if applicable), a summary of adverse events, and a copy of the updated protocol and statistical analysis plan (if not …
Plain Language Study Results Summaries - Pfizer
Please use the search function below to find Plain Language Study Results Summaries for Pfizer-sponsored global clinical trials. For more information about a specific study, please visit …
Post after the trial is closed to recruitment and no later than 60 days after the last study visit. Even if more than one IRB approved ICF exists, only one IRB approved ICF must be posted.
Timeline and Format for Summary Results Reporting
Aug 11, 2025 · This article explains the key timelines and formatting expectations for summary results reporting under major regulations, including FDAAA 801 in the United States, the EU Clinical Trials …
ClinicalTrials.gov Study Registration & Submission of Summary …
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires responsible parties to register clinical trials and submit summary results to ClinicalTrials.gov.
Best Practices For Complete Registration And Reporting Of Summary ...
Mar 5, 2024 · Sponsors of clinical trials and other responsible parties are required to register certain trials and submit their summary results information to this data bank.
Best Practices For Complete Registration And Reporting Of Summary ...
Mar 5, 2024 · Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. …
On to the Next Level: ClinicalTrials.gov Goes (More Fully) Plain!
Dec 14, 2022 · This unemotional announcement is a tremendous move toward more understandable entries in ClinicalTrials.gov (CT.gov)—that is, a move returning to CT.gov’s original intentions.