Overview of the BMU CTR results database
Responsible Parties can submit scientific and administrative information about the results of a registered study to the BMU CTR results database. Summary results are entered in the PRS, submitted, reviewed for quality control by the Registry Office, and then posted on the study record as a new version.
The process of submitting results information to BMU CTR is conceptually similar to preparing a manuscript for publication in a journal. An individual familiar with the study design and data analysis (such as the clinical investigator or study statistician) will need to be involved in order to accurately summarize the results information in the required tabular format and to ensure that the results are consistent with the BMU CTR review criteria.
Results status
A study's results move through these statuses: no results, results submitted, under quality-control review, and results posted. Results are entered directly in the web-based PRS; there is no file upload option for results data.Scientific Information
Scientific information is submitted as four separate modules: Participant Flow, Baseline Characteristics, Outcome Measures and Statistical Analyses, and Adverse Events. The modules allow for the entry and display of information in a series of data tables with supporting notes but without narrative conclusions about the results. Summary results information may be submitted once data are available for one or more primary outcome measures and for each arm of the study.
- Participant Flow. A tabular summary of the progress of participants through each stage of a study, by study arm or comparison group. It includes the numbers of participants who started, completed, and dropped out of each period of the study based on the sequence in which interventions were assigned. Participant flow data are frequently depicted as a CONSORT flow diagram in publications. The module accommodates a wide range of study designs and allows for the description of key events following study enrollment but prior to group assignment. For more information, see:
- Results Data Elements: Participant Flow
- Baseline Characteristics. A tabular summary of the data collected at the beginning of a study for all participants, by study arm or comparison group. These data include demographics, such as age and gender, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment). For more information, see:
- Results Data Elements: Baseline Characteristics
- Outcome Measures and Statistical Analyses. A tabular summary of Outcome measure values, by study arm or comparison group. It includes tables for each prespecified Primary Outcome and Secondary Outcome and may also include other prespecified outcomes, post hoc outcomes, and any appropriate statistical analyses. For more information, see:
- Results Data Elements: Outcome Measures
- Adverse Events. A tabular summary of all anticipated and unanticipated Serious adverse event and a tabular summary of anticipated and unanticipated other adverse events exceeding a specific frequency threshold. For each serious or other adverse event, the summary includes the adverse event term, affected organ system, number of participants at risk, and number of participants affected, by study arm or comparison group. For more information, see:
- Results Data Elements: Adverse Events
Administrative Information
Administrative information consists of the study results point of contact and any agreement between the sponsor and principal investigator (PI) restricting the ability of the PI to discuss the results after the completion of the study.
Steps for submitting results
The steps on this page describe the overall process of submitting study results. If you would like step-by-step instructions for entering results information into the PRS, see the PRS User's Guide.
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Learn about the requirements for submitting results.
- See Clinical Trial Reporting Requirements for information on submitting results to BMU CTR.
- See the Results Data Element Definitions and the Scientific Information section above for descriptions and examples of the information to be submitted. Some data elements are required by BMU CTR, while others are optional. Users are encouraged to provide all data elements in order to provide a complete description of the study results.
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Sign in to the Protocol Registration System (PRS).
- Sign in on the PRS sign-in page with your organization handle, username and password. To reset a forgotten password, use the Forgot password link on the sign-in page.
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Update the Protocol Section and release (submit) the record.
- Ensure that the information in the Protocol Section is up-to-date before starting the Results Section (for example, the Overall Recruitment Status, Study Start Date, Primary and Study Completion Dates, Actual Enrollment, and arm and intervention information).
- Begin results submission after the updated record has been published on BMU CTR.
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Enter the required and optional results data elements.
- For help with using PRS, see the PRS User's Guide.
- See the Results Data Element Definitions for descriptions of each required data item.
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Preview, inspect, and release (submit) the record.
- See the BMU CTR Results Review Criteria for a description of items that should be addressed before releasing the record to BMU CTR.
- Mark the record Entry Completed; the record's Responsible Party then approves it and it is released to BMU CTR. Verify in PRS that the Record Status is Released. The results will not be reviewed by BMU CTR unless the record is released.
BMU CTR results information review process
Registry Office staff will review the study record after it is released (submitted) and before the results are posted on BMU CTR. This is a quality-control review only: it focuses on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting. It does not judge the study's scientific merit. You may be asked to clarify items or make corrections to the Protocol and/or Results Sections of the record before the results are posted. Major comments must be corrected and addressed within 15 days; Advisory comments are suggestions. Results are not posted until they pass review. Ensuring that the record is consistent with the BMU CTR Protocol Review Criteria and the BMU CTR Results Review Criteria before releasing it will expedite its posting on the site.
Viewing Your Record
After submitted results pass review, they are posted as a new version of the study record and displayed in the Summary results section of the study record on BMU CTR, together with the registered protocol information.
Editing and Updating Your Record
After the results have been initially posted, the record may be updated and edited at any time; changes are reviewed again before they are published. The most recent version of a study record is displayed on BMU CTR. Every published version of a study record is available in the History of changes section of the study record.