This page is a compendium of helpful resources for data submitters.
Many of these items are informative in nature, while others provide instructional information for various aspects of the protocol/results reporting process or using the Protocol Registration System (PRS). If you need help that is not covered here, contact the Registry Office through Support.
Protocol registration
Using the PRS
- PRS User’s Guide — Describes how to use the PRS to manage accounts, maintain records, and submit clinical study information to BMU CTR, including step-by-step instructions for PRS functions.
- How to Register Your Study, How to Edit Your Study Record and How to Submit Your Results — Overviews of each step of the PRS workflow.
- How to Apply for a PRS Account — How to apply for a PRS organization account or join your organization's existing account.
Requirements
- Clinical Trial Reporting Requirements – BMU CTR registration policy, including prospective registration of interventional trials before the first participant is enrolled.
- Policy FAQs – Answers to common questions about registering studies and submitting results on BMU CTR.
Templates and Resources
- Protocol Registration Data Element Definitions – Descriptions and examples of the information to be submitted for interventional and observational studies.
- Expanded Access Data Element Definitions
- Plain Language Guide to Write a Brief Summary – A helpful guide for writing brief summaries of clinical studies using plain language accessible to a general audience.
- Template for writing a brief summary for the study overview – A suggested template that may be useful for writing brief summaries.
- WHO International Clinical Trials Registry Platform (ICTRP) – BMU CTR records follow the WHO Trial Registration Data Set, and BMU CTR data are submitted to the WHO ICTRP.
Results submission
- Results Data Element Definitions – Descriptions of each results data element.
- How to Submit Your Results – Overview of the results modules and the results review process.
Quality control review
These documents provide an overview of the quality control (QC) process:
- Protocol Registration Quality Control Review Criteria
- Results Quality Control Review Criteria
- Major Comments – Common major comments found during QC review, which must be addressed within 15 days.