How to Register Your Study

Steps for registering a clinical study

The steps on this page describe the overall process of registering studies. If you would like step-by-step instructions for entering registration information into the PRS, see the PRS User’s Guide.

1. Determine who is responsible for registering the clinical study and which Protocol Registration System (PRS) account should be used
   • See the Responsible Party FAQs for information on how to determine if you’re the right person to register a study and submit results.
   • See How to Apply for a PRS Account to learn how to determine whether your organization already has a PRS organization account, request to join it, or apply for a PRS organization account.
2. Learn about submission requirement
   • BMU CTR allows the registration of clinical studies with human subjects that assess biomedical and/or health outcomes and that conform to:
     • Any applicable human subject or ethics review regulations (or equivalent)
     • Any applicable regulations of the national or regional health authority (or equivalent)
   • Ethics approval is given by an ethics committee (IRB) outside BMU CTR; you record the approval on the study record.
   • See Clinical Trial Reporting Requirements for background information on the reasons for registering a clinical study.
   • See the Protocol Registration Data Element Definitions for descriptions and examples of the information to be submitted. BMU CTR records follow the WHO ICTRP Trial Registration Data Set. Some data elements are required by BMU CTR, while others are optional for BMU CTR but may be required by the International Committee of Medical Journal Editors, or other organizations. Users are encouraged to submit all data elements in order to provide a complete description of the study.
3. Sign in to 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.
4. Enter the required and optional data elements.
   • For help with using PRS, see the PRS User's Guide.
5. Preview, inspect, and release (submit) the record.
   • See the BMU CTR Protocol Review Criteria for a description of items that should be addressed before releasing the record to BMU CTR
   • When data entry is finished, 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 record will not be reviewed by BMU CTR unless it is released.

Considerations for observational studies and expanded access records

Registering observational studies

The Observational Study Type (see Study Type data element on BMU CTR) can be used to register studies of human beings in which biomedical and/or health outcomes are assessed in predefined groups of individuals, but the investigator does not assign specific interventions to the study participants. This will provide access to the Observational Study Design data elements on BMU CTR, including Observational Study Model, Time Perspective, and Biospecimen information.

The Patient Registry Observational Study Subtype (see Study Type data element on BMU CTR) can be used to indicate that an observational study is also considered to be a Patient Registry. A Patient Registry is an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single-purpose or ongoing data collection programs that address one or more questions.

Observational study records should be updated and maintained in the same manner as interventional study records.

Registering expanded access records

Expanded access (sometimes also referred to as "compassionate use") is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

If expanded access to an investigational product studied in a registered trial is available, the Responsible Party can select "Yes" for the Availability of Expanded Access data element and submit information for an expanded access record. Expanded access must follow the rules of the relevant regulatory authority.

Additional information about expanded access is available on BMU CTR:

• Glossary: Expanded access
• BMU CTR: Registration Data Element Definitions for Expanded Access

BMU CTR protocol information review process

Registry Office staff will review the study record after it is released (submitted) and before it is published on BMU CTR (PRS Review). 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 or ethics. Ensuring that the record is consistent with the BMU CTR Protocol Review Criteria before releasing it will expedite publication on the site.

If the reviewer finds problems, the record is returned to you with review comments. Major comments must be corrected, and must be addressed within 15 days; Advisory comments are suggestions to improve the record. See Major Comments. After you address the comments, approve and release the record again for another review. No record is published until it passes review; BMU CTR does not post records with unresolved comments.

When the record passes review, it is published on BMU CTR and assigned its permanent BDCTR ID (format BDCTR-YYYY-NNNNNN).

Required registration updates

Responsible Parties should update their records within 30 days of a change to any of the following:

• Individual Site Status and Overall Recruitment Status data elements on BMU CTR
• Primary Completion Date data element on BMU CTR

Other changes or updates to the record should be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.

See How to Edit Your Study Record for details on updating study information.

Submitting results

When your study has results, the Responsible Party can enter summary results in the PRS and submit them. Results are quality-control reviewed and then posted on the study record as a new version. See How to Submit Your Results for more information.