Frequently asked questions
What studies need to be registered?
All clinical trials involving investigators and participants, from diferent countries, in all areas of health and testing all forms of interventions should 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 and include drugs, surgical procedures, devices, behavioural treatments, etc. If in doubt about whether to register or not, registration is recommended.
When should studies be registered?
Trials should be registered after approval from a national ethics committee and before enrolment of the first patient. Because it was developed out of 2010, and on determination of WHO and Ministry of Health, was agreed that only studies to date of recruitment from January 1, 2010 onwards can register on Rebec to start work in conjunction with the launch of the site, since the volume of of research conducted is huge and we would not have to meet demands before this date.
Who is responsible for registering a trial?
The study's coordinator, sponsor or an appropriate representative is responsible for registering a trial. The sponsor is the study proponent, while the source of monetary or material support is the individual or company, public or private, which financially supports the research. According to the resolution RDC 39 from ANVISA, in clinical studies sponsored by national or international agencies to promote the research, philanthropic entities, non-governmental organizations (NGOs) or other non-profit organizations, it is assumed that investigator assumes the role of representative of the sponsor, if there is a Clinical Research Organization (CRO) responsible for the conduct of it, should meet as a representative of the study. In the case of independent studies, for which the investigator has no financial assistance from a specific sponsor, including cases in receiving the medicines of research in the form of donation where the donor does not want to be characterized as a sponsor of the study, the researcher additionally assume the responsibilities of registering the study. For the cases referred to in the preceding paragraph, the researcher is now called "investigator-sponsor." All register fields are translated into english by the responsible registrant.
How do I register a trial?
First time users need to create a login name and password by clicking on the Register button. A confirmation e-mail will be sent to the informed e-mail account.
The New Submission button will take the registrant to the screens that need to be completed. This includes basic trial information such as the types of participants, the interventions being tested and the outcomes to be assessed. Other information required includes details of the study design, sample size and contact information. Each field has an information button to assist registrants in entering the correct data. Once each screen is completed, the registrant should click the 'Save' button to save the information to the online registry database. Once all the mandatory information has been entered, the registrant should click the 'Send to review' button.
Following submission of the data, the REBEC staff will check the data submitted and query the contact person should anything need clarification. Once any queries are confirmed, trials are officially 'registered' and allocated a unique registration number. Both date of submission and date of registration are recorded.
The average time to final publication may vary according to the size of the study and its information and the brief return of registrants (users responsible), to requests from reviewers ReBEC.
How to cite a record on a clinical trials register
Based on the guidelines for Vancouver style referencing for "Part of a database on the internet" (see http://www.nlm.nih.gov/bsd/uniform_requirements.html), and the Citing Medicine guidelines of the National Library of Medicine (NLM) http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=citmed.section.57708) it is therefore recommended that a citation of a record on a trial register consist of: * name of the database * location and name of the publisher of the database - the year the site was first developed/online * unique ID * title of the record * date of registration * date when it was cited * approximate number of pages - the web address of the record Example: ReBEC - Registro Brasileiro de Ensaios Clínicos [Internet]: Rio de Janeiro (RJ): Instituto de Informação Científica e Tecnológica em Saúde (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.ensaiosclinocos.gov.br/rg/RBR-XXXXXX/
When to cite a record on a clinical trials register?
The registry record will be the only publicly available document on a trial until results from the trial are published. Some examples of situations when studies might be quoted are: When a manuscript reporting the results of the trial is published or otherwise reported When a manuscript reporting methodological issues relating to a particular trial are published or otherwise reported In protocols to systematic reviews, or in completed systematic reviews (e.g. when a list of ongoing trials are included) In protocols to prospective meta-analyses, which will list the ongoing trials to be included In any manuscript when reference to an ongoing or unpublished (or even published) trial might be relevant
Is mandatory to register all clinical trials at the Brazilian Clinical Trials Registry to obtain the approval of ANVISA for the conduct of clinical research?
No.
What are the objectives of the Brazilian Clinical Trial Registry?
Estabilish a broad and update register of clinical trials with researchers and participants from Brazil, Latin America and the Caribbean Provide access to interested stakeholders of ongoing or completed clinical trials - source of reliable and free of charge data to be used in systematic reviews/metanalyses, evidence-based guidelines, research policy Increase transparency in research, strenghening the ethical and cientific value of clinical trials Facilitate the discovery and control of design, publication bias and reduce language bias Integrate into ethic and regulatory processes Attend the national and regional information needs
What are the benefits of a Clinical Trials Registry?
A Clinical Trials Registry can enhance the efficacy of current clinical trials studies by: Reducing the unnecessary duplication of research efforts because those who are planning new studies will be aware of all existing trials Raising the recruitment rates of participants of clinical trials (especially for rare diseases or high risk conditions) and therefore increasing the chances of well succeeded outcomes of some clincial trials Giving aggregate value to research results by providing a source of reliable and non-biased information on clinical trials for use in systematic reviews, metanalyses and evidence-based guidelines Enhance the available evidences to health decision taking
Is the registration of a clinical trial at Plataforma Brasil equivalent to the registration at Brazilian Clinical Trials Registry?
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.
What documents I must have on hand before registration?
Before initianting your registration, be sure you have on hand the protocol of your study, as well as a copy (in PDF format) of the letter of approval from a brazilian ethics committee/institutional review board and the UTN number. Those documents will be the sources of information necessary to fill all the obligatory fields required for the registration of your study. The letter of approval must be uploaded in the attachments section of the registration form. This document is a proof of the existence of the study and that it was approved by a brazilian EC/IRB. If you wish to make it public, that meansit will be viewed by all users, mark the Public field. Otherwise, it will be viewed only by the REBEC staff. The UTN is a number, obtained by the trial's sponsor, proponent institution or principal investigator as the first step in registering a trial on the REBEC. The UTN will then become part of the trial's international identity along with the REBEC registration number. If your study is internationally multicentric trial, check out if it has a UTN. To obtain the UTN you must acces the site https://apps.who.int/utn/
Can a trial be removed from REBEC database once it has been registered?
In accordance to the International Standards for Clinical Trial Registries of ICTRP, the responsible registrants are informed in the Terms of Use of REBEC, at the time of registration, that a trial cannot be deleted once it has been registered. Although trial records cannot be deleted, REBEC consider removing a trial record from public view, but in exceptional circumstances only. For example: when it has been proven that the trial is bogus or fraudulent; when the trial has inadvertently been registered twice on the same registry.
How can I participate as a volunteer in a clinical trial?
If you are interested in participating in a study published in ReBEC procedures are: Step 1 - On the homepage, click on " advanced search"; Step 2 - On this page , type the object of his interest in " Essays containing the words"; Step 3 - Select the country of recruitment (in this case Brazil); Step 4 - Select the " All " in " Study Type " and select " Both " on "Gender Inclusion"; Step 5 - In the " Situation recruitment " select options "Not yet recruiting " and "Recruiting"; Step 6 - The remaining fields are not mandatory, so you can leave them blank; Step 7 - At the end of the page , click " Search trials". After these procedures, will present the studies published on our website, with the characteristics of their need. This way you can access each one, see which most closely match what your expectations and needs, which are closest to their home or place of work (which facilitates their participation) and, most importantly, the name, address, email and phone contact with the head, you will find in "Contacts to public issues" at the end of each page of the study. Contact, expose their interest in participating and you receive proper guidance.
Is there a manual for registering a study in REBEC?
Yes, you can download it from LINK.
Username/Password
Public trial
Effects of Marijuana on the quality of life of Cancer patients
Date of registration: 03/28/2023 (mm/dd/yyyy)Last approval date : 03/28/2023 (mm/dd/yyyy)
Last revision: 1
Study type: Interventional
Evaluation of the dermatological acceptability of a health product using the product at home
Date of registration: 03/28/2023 (mm/dd/yyyy)Last approval date : 03/28/2023 (mm/dd/yyyy)
Last revision: 1
Study type: Interventional
The effectiveness of Auricular Vagus Nerve Electrical Stimulation associated with Global Osteopathic Treatment in patients with Fibromyalgia
Date of registration: 11/30/2022 (mm/dd/yyyy)Last approval date : 03/28/2023 (mm/dd/yyyy)
Last revision: 2
Study type: Interventional
Justicia Pectoralis Syrup for Cough in children
Date of registration: 03/27/2023 (mm/dd/yyyy)Last approval date : 03/27/2023 (mm/dd/yyyy)
Last revision: 1
Study type: Interventional
Effects of Brain Stimulation on Runners
Date of registration: 03/27/2023 (mm/dd/yyyy)Last approval date : 03/27/2023 (mm/dd/yyyy)
Last revision: 1
Study type: Interventional
Evaluation of Cardiac Alterations in Tooth Removal Surgery
Date of registration: 03/27/2023 (mm/dd/yyyy)Last approval date : 03/27/2023 (mm/dd/yyyy)
Last revision: 1
Study type: Interventional
Effect of Long-Term Dietary Nitrate Intake on health parameters in individuals undergoing Physical Activity
Date of registration: 03/27/2023 (mm/dd/yyyy)Last approval date : 03/27/2023 (mm/dd/yyyy)
Last revision: 1
Study type: Interventional