Frequently Asked Questions | BMU Clinical Trial Registry

General

Is there a charge for listing studies on BMU CTR?

No, there is no charge for listing studies on BMU CTR. BMU CTR is a free service provided by the Registry Office at Bangladesh Medical University.

Which studies must be registered on BMU CTR?

BMU CTR registry policy requires interventional clinical trials to be registered before the first participant is enrolled (prospective registration). From 1 January 2027, interventional trials seeking ethics approval in Bangladesh must be registered on BMU CTR. Other types of studies, such as observational studies, patient registries and expanded access, may also be registered.

Studies are registered by an organization with a PRS organization account. The record must be approved by its Responsible Party before it is released to BMU CTR (see Responsible Party data element).

See How to Apply for a PRS Account and Reporting Requirements for more information.

My study is not yet approved by a human subjects review board (ethics review committee, institutional review board). Can I enter it on BMU CTR?

Most studies require approval from a human subjects review board. If your study requires approval, you may register your study on BMU CTR prior to getting approval if the Overall Recruitment Status of the study is Not yet recruiting (see Overall Recruitment Status data element). BMU CTR does not review or grant ethics approval; the approval is given by an external ethics committee and recorded on the study record.

If a study requires human subjects review board approval, approval must be obtained before the study's Overall Recruitment Status is changed to Recruiting. When board approval is obtained, please update the ethics approval information in the Protocol Registration System (PRS), mark the record Entry Completed, have it approved by the Responsible Party and Release it for PRS Review.

See How to Register Your Study and How to Edit Your Study Record for more information.

Why can't I find my study on BMU CTR?

It might not have been Released (submitted) to BMU CTR for processing. After a record has been entered into PRS (or modified) and marked as Entry Completed, it must be Approved and Released by the Responsible Party (see Responsible Party data element).

The study might also be undergoing PRS Review. After the Responsible Party Releases (submits) information to BMU CTR, the Registry Office carries out a quality-control review to identify possible errors, deficiencies, or inconsistencies that are not detected automatically during data entry. This review does not judge the scientific merit or ethics of the study. Nothing is made public until the record passes this review. If the Registry Office finds issues, it returns the record with Major comments (which must be corrected) and Advisory comments; Major comments must be addressed within 15 days.

See How to Register Your Study, Major Comments and How to Submit Your Results for more information.

When will the BDCTR ID for my study be assigned?

The BDCTR ID, also called the BMU CTR Identifier, is assigned after the protocol information has been Released (submitted) by the Responsible Party and has passed PRS Review by the Registry Office. It is assigned when the record is first published and does not change. BDCTR IDs have the format BDCTR-YYYY-NNNNNN (for example, BDCTR-2026-000001).

See How to Register Your Study for more information.

My study is also registered in another registry. Can I record its other registry ID?

Yes. Identifiers from other registries, including NCT numbers, can be recorded as secondary IDs on the BMU CTR record. The study still receives its own BDCTR ID when it is published.

Can I register a study after it has started, has closed to recruitment, or has been completed?

BMU CTR registry policy requires interventional trials to be registered before the first participant is enrolled. From 1 January 2027, interventional trials seeking ethics approval in Bangladesh must be registered on BMU CTR. In addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.

If your study has already started, please contact the Registry Office through Support before registering it. See Reporting Requirements for more information.

Must clinical studies with no external sources of funding ("unfunded" studies) be registered on BMU CTR?

BMU CTR registry policy and the International Committee of Medical Journal Editors (ICMJE) policy on Clinical Trial Registration under the ICMJE Recommendations do not exclude clinical studies with no external sources of funding ("unfunded" studies).

In general, an unfunded study should be registered via the PRS organization account of the Sponsor. When an investigator is considered the Sponsor (a Sponsor-Investigator), the study should be registered using the PRS organization account of the investigator's affiliated institution with the Responsible Party indicated as Sponsor-Investigator. The Protocol Registration Data Element Definitions page on BMU CTR describes the related data elements for Responsible Party.

Is BMU CTR part of the WHO International Clinical Trials Registry Platform (ICTRP)?

BMU CTR records follow the WHO ICTRP Trial Registration Data Set (TRDS), and BMU CTR data is submitted to the WHO ICTRP.

How do I contact BMU CTR if I have a question about my study record?

If you have questions or need help updating your record, contact the Registry Office through Support. If the question is about a specific study record, please provide the BDCTR ID or the Unique Protocol ID (if a BDCTR ID has not yet been assigned). Please include enough information about the issue so that we may better assist you.

Protocol Registration System

Can an organization have multiple users for a single account?

Yes. BMU CTR establishes one PRS account for an organization (such as a company, university, or medical center). All investigators from that organization who are conducting studies are typically designated as users of this single PRS account. The organization should designate one or more PRS Administrators to manage the account and to create logins for additional users.

See How to Apply for a PRS Account and the list of organizations with a PRS account for more information.

What happens after I release my record to BMU CTR?

After the Responsible Party approves and Releases the record, it enters PRS Review: a quality-control review by the Registry Office. The review checks the record for errors, deficiencies and inconsistencies; it does not judge the scientific merit or ethics of the study.

If the record passes review, it is published on BMU CTR and, on first publication, assigned a BDCTR ID. If not, it is returned with Major comments (which must be corrected) and Advisory comments. Major comments must be addressed within 15 days. Nothing is published until the record passes review.

See Protocol Registration Quality Control Review Criteria and Major Comments for more information.

How do I update my record after it has been published?

Edit the record in the PRS. The changes go through the same steps as a new record: Entry Completed, approval by the Responsible Party, release and PRS Review. The updated version is published once it passes review. Every published version remains viewable in the record's History of changes.

See How to Edit Your Study Record for more information.

How are summary results submitted and posted?

Summary results are entered in the PRS for the study record and submitted. The Registry Office reviews them for quality control, and once they pass review they are posted on the study record as a new version.

See How to Submit Your Results and Results Quality Control Review Criteria for more information.