All clinical trials with investigators and participants from different countries, in all health fields, and testing all forms of interventions can and should preferably be registered.

Studies must meet the WHO / ICMJE 2008 definition of a clinical trial to be registered. That is, any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Medical interventions include any intervention used to modify a health outcome, which may include drugs, surgical procedures, devices, behavioral treatments, among others.

In case of doubt whether a clinical trial should be registered or not, registering the study is recommended.

Registration must be completed after approval by the Research Ethics Committee (CEP/CONEP) and preferably before enrolling or recruiting the first patient. Although ReBEC accepts registration after recruitment has already started, registering prospectively—before including the first participant—is essential to ensure the article's acceptance by major scientific journals, which usually reject studies with retrospective registration.

Research registration in ReBEC may be carried out by the sponsor or their representative, in accordance with the responsibilities defined for the study.
In investigator-initiated clinical trials, the institution with which the researcher is affiliated acts as the primary sponsor and may delegate responsibilities to the researcher, who will act as the secondary sponsor.

This definition aligns with Law No. 14,874/2024 and Anvisa RDC No. 945/2024.

1. The first time, users need to create a login name and password by clicking on the 'Register' button.
    
2. A confirmation email will be sent to the provided email account for password activation (if you cannot find it in your inbox, check the spam or junk folder of the registered email).
    
3. To create a login, the registrant can only use letters, numbers, periods ('.'), and underscores ('_') in their username.
    
4. The 'New Submission' button will take the applicant to the screens that need to be filled out. This includes basic information, such as participant types, the interventions being tested, and the outcomes to be evaluated. Other required information includes study design details, sample size, and contact information.
    
5. Each field has a help option ("?" icon) to assist applicants in entering the correct data.
    
6. Once each form is filled out, the applicant must click the 'Save' button to save the information in the Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos).
    
7. Once all required information has been filled out in the forms, the applicant must click the 'Submit' button.
    
8. After data submission, the ReBEC team will analyze it and check if further adjustments are needed. If necessary, the applicant will receive a communication via the registered email.
    
9. Once all questions are clarified, the studies are officially registered, and a unique registration number will be assigned. Both the submission date and the registration date are stored.
    
10. The average timeframe for publication may vary depending on the size of the study and its information, as well as the prompt response of the registrants (responsible users) to the ReBEC reviewers' requests.

Following the Vancouver reference model for Part of a database on the internet and the citation guidelines of the National Library of Medicine (NLM), it is recommended that the citation of a clinical trial record includes:

1. Name of the database
2. Location and name of the entity responsible for the database
3. The year the site was developed/launched online
4. The unique identification number (ID)
5. Title of the record
6. Date of registration
7. Date when it was cited
8. Approximate number of pages
9. The web address of the record.

Example: ReBEC - Registro Brasileiro de Ensaios Clínicos [Internet]: Rio de Janeiro (RJ): Institute of Scientific and Technological Information in Health (Brazil); 2010 - . Identifier RBR-XXXXXX. A multi-centre, randomised, double-blind, placebo-controlled clinical trial examining the efficacy and safety of low-dose aspirin after initial anticoagulation to prevent recurrent venous thromboembolism; 2010 Jul 12 [cited 2008 June 18]; [1 page]. Available from http://www.ensaiosclinicos.gov.br/rg/RBR-XXXXXX/

1. When a manuscript reporting the trial results is published or reported;
    
2. When a manuscript reporting methodological issues regarding a specific trial is published or reported;
    
3. In protocols for systematic reviews or completed systematic reviews. For example, when a list of ongoing trials is included;
    
4. In protocols for prospective meta-analyses that will list ongoing trials to be included;
    
5. In any manuscript when a reference to an ongoing or unpublished trial, or even when published, could be relevant.

No. According to ANVISA Resolution - RDC 9/2015, ReBEC is one of the existing registration options. Once published on ReBEC, your study will be included in the International Clinical Trials Registry Platform / World Health Organization (ICTRP/WHO) clinical research registration database.

Note:

1. Studies must mandatorily be registered in Portuguese and English.
2. The Spanish language is optional.

1. Establish a broad and updated registry of interventional and observational studies in Brazil, Latin America & the Caribbean;
    
2. Provide stakeholders with access to ongoing or completed studies, reliable data, and no burden/cost for reviews/meta-analyses, guidelines, and research policies;
    
3. Increase transparency in research, strengthening the ethical and scientific value of interventional and observational studies;
    
4. Facilitate the discovery and control of design and publication biases and reduce language barriers;
    
5. Promote integration with ethical and regulatory processes;
    
6. Meet national and regional information needs.

Registering can increase the efficacy of current clinical trial efforts by:

1. Reducing unnecessary duplication of research efforts, because professionals planning new studies will be aware of all existing trials;
    
2. Increasing participant recruitment rates for clinical trials, especially for rare diseases or high-risk conditions. Thus, increasing the chances of successful outcomes for some clinical trials;
    
3. Adding value to research results by providing a reliable source of information on clinical trials for systematic reviews, meta-analyses, and evidence-based guidelines;
    
4. Improving available evidence that guides healthcare practices.

No. The study registration at Plataforma Brasil must be done before its registration at the Brazilian Clinical Trials Registry (ReBEC).

Although the form of RBEC share many of its fields with Plataforma Brasil, the objective of ReBEC is to inform all national and international interested stakeholders about clinical trials performed in Brazil through the integration of RBEC and International Clinical Trials Registry Platform (ICTRP / World Health Organization). This integration is based upon the adoption of standard operating procedures defined by the Secretariat of th ICTRP.

1. Before starting the registration of your study, make sure you have on hand your study protocol, as well as a copy of the approval document (in PDF format) issued by the Ethics Committee and the UTN (Universal Trial Number). These documents will be the sources of necessary information to fill in all mandatory fields for registering your study;
    
2. The approval document must be attached in the 'Attachments' section of the platform. This document is proof of the existence of your study and that it was approved by an ethics committee;
    
3. If you want this document to be public, meaning it will be seen by all users, check the 'Public' field in the 'Attachments' section. Otherwise, it will only be seen by the ReBEC team;
    
4. The UTN is a number obtained by the sponsor or trialist as a first step in registering the trial in ReBEC. The UTN will become part of the trial's international identity, along with the ReBEC registration number;
    
5. If your study is an international multicenter trial, check if it already has a UTN. To obtain the UTN, you must access the website https://apps.who.int/utn/.

In accordance with the ICTRP (International Clinical Trials Registry Platform) International Standards for Clinical Trial Registries, at the time of registration, responsible registrants are informed in the 'ReBEC Terms of Use' that a clinical trial cannot be deleted after it has been registered.

However, only under exceptional circumstances may ReBEC consider removing it from public view, but never deleting it. For example: when it is proven that the trial is fake or fraudulent; or when a trial is inadvertently registered more than once in ReBEC.

If you are interested in participating in any study published on ReBEC the procedures are:

Step 1 - On the home page, click on 'advanced search';

Step 2 - On this page, type your topic of interest in 'Trials containing the terms';

Step 3 - Select the recruitment country (in this case, Brazil);

Step 4 - Select the 'All' option under 'Study Type' and select 'Both' under 'Inclusion Gender';

Step 5 - In the 'Recruitment Status' field, select the options 'Not yet recruiting' and 'Recruiting';

Step 6 - The remaining fields are not mandatory, so you can leave them blank;

Step 7 - At the bottom of this page, click on 'Search trials'.

After these procedures, the studies published on our website will be displayed, matching your needs. This way, you will be able to access each one of them, check which ones best meet your expectations and needs, which ones are closest to your home or workplace (making your participation easier), and, most importantly, the name, address, email, and phone number for direct contact with the person in charge, which you will find under 'Contacts for Public Queries', at the end of each study page.

Get in touch, express your interest in participating, and you will receive the proper guidance.

Yes. You can download the 'Registrant Manual' through this LINK.