Clinical Trials Registration Instruction

1. Note for Registry

   • The Clinical Trials Registry (The Registry) will process trial data approved by the appropriate research ethics board/committee.
   • Registration with the Registry is voluntary and free of charge.
   • The registered owner is responsible for the accuracy of the data as well as the completeness of the dataset, as required by the WHO ICTRP/ICMJE at the time of submission. The Registry reserves the right to request additional data as required by WHO ICTRP/ICMJE from time to time.
   • All submitted data must be reviewed, verified, and updated every six months by the submitting party. The submitting party is responsible for updating the Registry with the following information:
     • Changes in the subjects/patients recruitment status
     • Any changes/updates in the trial information in the Registry
     • Any condition leading to premature termination
   • A registration data set will be considered inadequate and may not be recognized by the WHO ICTRP/ICMJE if it has missing fields or fields that contain uninformative terminology.
   • All data must be submitted in English (except for the Chinese title).
   • All trials in this Registry are represented by a unique identifier and made permanently available to the public. The submitting party is responsible for ensuring that the sponsor(s) or the funding agency(ies) have no objection to the posting of the trial information within this Registry permanently.
   • The Registry will follow the recommendation of WHO ICTRP/ICMJE to process, organize, transmit and display the trial data, and to make corrections and improvements to the website without prior notice.
   • Registration of a trial to the Registry (CCRB Clinical Trial Registry) does not guarantee successful registration to the Primary Registry (ChiCTR). All applications are subject to further review and approval by the Primary Registry.

2. Account Application Procedures

   1. Principal Investigators or Research Team members wishing to register a trial must first apply for a registration account at HERE and complete the fields in the “User Account Registration” form/webpage.
   2. A message will be sent to you via email, which directs you to the webpage to activate your registration account. After a password is entered and confirmed, you can log in to the Registry with your email address as the username.
   3. This username and password are used to access all your registrations in the Registry.

3. My Registration Page

   1. After login to the Registry, you can access “My Registration Page” which provides you with a summary table of your registrations in the Registry.
   2. Information of each registration includes, but not limited to, Trial Details, CCRBCTR Unique Trial Number, Recruitment Status, Official Study Title, Submission Date, Last Update Date, Submission Status and User Role can be found in the table.

4. User Roles in CCRB-Clinical Trial Registry

   1. In the Registry, you will be asked if you are the registration “owner” (Principal Investigator of the trial – at the time of application) or the “helper” of the registration before creating a trial registration record.
   2. If you are the registration “owner”,
      1. you can enter, edit, upload and endorse the trial data to be submitted to the registry.
      2. You can add/delete “helpers” for assisting the registration process.
      3. Unlock the registration form for data change by a “helper” before the registry submission.
      4. you are responsible for the accuracy of the data as well as the completeness of the dataset and;
      5. you can transfer the registration ownership to your colleague to endorse and manage the registration record.
   3. If you are the “helper” of the registration,
      1. You can assist the registration “owner” in entering, edit, upload and update the trial data in the registration form.
      2. You can lock the form for the review and endorsement of registration “owner”.

5. Registration submission and approval

   1. After login to the Registry, registration “owner/helper” can go to “My Registration Page” and access a new form for new registration.
   2. Registration “owner/helper” can complete the Registration Form, upload the IRB/IEC approval letter and the first page of the Chinese Informed Consent Form (if Chinese Title is entered to the system).
   3. When a form is complete and requested documents are uploaded to the system, registration “owner” must review and endorse the trial data and documents to be submitted to the registry.
   4. Once the endorsed e-registration form is received, the Registry will verify the information you submitted. When all valid information is obtained, the trial information will be registered on the Registry for public view.
   5. You will receive an automatic e-mail from acknowledging the successful registration of the trial data.

   *The application is not considered successful until it is reviewed and approved. Please ensure the study anticipated start date is at least 14 days after the submission date for the review process.

6. Recommendations for Retrospective Registered Trials

   As of 1st August 2012, we no longer accept registration for retrospective registered trials. If you want to register a retrospective trial, please contact other registries where retrospective registered trials are considered.

7. Disclaimer for retrospective registered trials:

   For the retrospective registered trials before 1 August 2012, whether a journal editor will decide to publish or reject the manuscript because it was registered after the first patient was recruited is up to the journal editor.

8. Note

   If you have any questions about trial registration, please contact the Registry via email: ccrb@cuhk.edu.hk

Last changed: 8/29/2015