Introduction
This page helps sponsors and investigators understand the key policy requirements for clinical trial registration and results submission to BMU CTR. The description of each requirement on this page includes an overview for quick reference, description, and links to supporting materials.
The 2 main reasons to register clinical trials and submit summary results are:
- Registration for certain clinical trials is required by policies such as:
- BMU CTR registry policy on prospective registration of interventional trials
- WHO International Clinical Trials Registry Platform
- The International Committee of Medical Journal Editors (ICMJE) Policy requires prospective registration to publish results from a clinical trial in medical journals
Read more about key policies on this page.
BMU CTR Registry Policy
Overview
- What is it? Registration and results policy of BMU CTR, operated by the Registry Office at Bangladesh Medical University
- Which clinical trials must follow it? Interventional trials registered with BMU CTR; from 1 January 2027, prospective registration is required for interventional trials seeking ethics approval in Bangladesh
- Does it require registration? Yes, prospective registration of interventional trials before the first participant is enrolled
- Does it require results submission? Summary results are submitted in the PRS, quality-control reviewed, and posted on the study record
Description
BMU CTR registry policy requires that interventional trials be registered prospectively, that is, before the first participant is enrolled. From 1 January 2027, this applies to interventional trials seeking ethics approval in Bangladesh. Ethics approval itself is granted by an external ethics committee or institutional review board (IRB) and is recorded on the study record.
Study records are entered in the Protocol Registration System (PRS). After the record's Responsible Party approves and releases a record, the Registry Office carries out a quality-control (QC) review. The review checks the record for completeness, consistency and clarity; it is not a judgement of scientific merit or ethics. Comments are either Major (must be fixed) or Advisory, and major comments must be addressed within 15 days. Nothing is published until the QC review passes. On first publication, the study receives a permanent BDCTR ID (for example, BDCTR-2026-000001).
Responsible Parties are expected to keep their records current. Changes to a published record go back through the same review cycle, and every published version remains viewable in the record's History of changes. Summary results are entered in the PRS, submitted, QC-reviewed by the Registry Office, and then posted on the study record as a new version. BMU CTR records follow the WHO Trial Registration Data Set and are submitted to the WHO ICTRP.
Supporting materials
- the Registry Office: How to Register Your Study
- the Registry Office: How to Submit Your Results
- the Registry Office: Protocol Registration Quality Control Review Criteria and Results Quality Control Review Criteria
- the Registry Office: Frequently Asked Questions (FAQs)
International Committee of Medical Journal Editors (ICMJE) Policy
Overview
- What is it? Publication policy initiated by the ICMJE in 2004
- Which clinical trials must follow it? Any (includes drugs, biological, and device products, as well as surgical procedures, and behavioral treatments)
- Does it require registration? Yes, for all interventional studies, including Phase 1 studies, and defines criteria for "acceptable registries"
- Does it require results submission? No, but the ICMJE expects authors to meet results information submission requirements "of their funding and regulatory agencies" and "encourages... results reporting even when not required"
Description
In 2005, the ICMJE began requiring trial registration as a condition of publication. ICMJE issued a clinical trial registration policy as part of the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, which is followed by more than 1,000 journals. The ICMJE Recommendations encourage journal editors to require that all clinical trials be entered in a public registry before the start of participant enrollment for the trials to be considered for publication. The ICMJE expects authors to meet all results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered. In June 2017, ICMJE amended its recommendations (PDF) to include registration of an individual participant data (IPD) sharing statement (see IPD Sharing Statement data element on BMU CTR) as an additional consideration for publication of reports for clinical trials that begin enrolling participants on or after January 1, 2019.
Supporting materials
- the Registry Office: Protocol Registration Data Element Definitions: BMU CTR records follow the WHO Trial Registration Data Set, required by the ICMJE registration policy
- ICMJE: Frequently Asked Questions About Clinical Trials Registration
- ICMJE Journals Stating that They Follow the ICMJE Recommendations: Journals that have asked ICMJE to include them on the list of journals that follows the ICMJE's recommendations
World Health Organization (WHO) International Clinical Trials Registry Platform
Overview
- What is it? International policy initiated by WHO in 2006 and affirmed by the signatories of the Joint Statement on Public Disclosure of Results from Clinical Trials(PDF)
- Which clinical trials must follow it? Any (includes drugs, biological, and device products, as well as surgical procedures, and behavioral treatments)
- Does it require registration? Yes, "The registration of all interventional trials is a scientific, ethical and moral responsibility"
- Does it require results submission? Yes, the 2015 WHO Statement on the Public Disclosure of Clinical Trials Results specifies that "[t]here is an ethical imperative to report the results of all clinical trials, including those of unreported trials conducted in the past"
Description
In 2006, WHO stated that all clinical trials should be registered, and it identified a minimum trial registration dataset. In 2007, WHO launched the International Clinical Trials Registry Platform (ICTRP), which includes a search portal providing a single point of access to studies registered in various international registries. BMU CTR submits its data to the WHO ICTRP.
The WHO International Clinical Trials Registry Platform (ICTRP) policy specifies that "the registration of all interventional trials is a scientific, ethical and moral responsibility." Accordingly, ICTRP provides a global forum for trial registries to share best practices and promotes the development of specific criteria for primary registries in the WHO Registry Network. In addition, the WHO Statement on Public Disclosure of Clinical Trials Results specifies that "[t]here is an ethical imperative to report the results of all clinical trials, including those of unreported trials conducted in the past."
Supporting materials
- WHO ICTRP Trial Registration Data Set: Describes the minimum amount of trial information that must appear in a clinical study registry in order for a given trial to be considered fully registered by the WHO
- WHO ICTRP Search Portal: Provides a single point of access to studies registered in various international registries, including data submitted by BMU CTR