Guidance on the registration of clinical trials and public disclosure of results: Resources
On this page
- WHO international standards and criteria
- Search portals and inventories
- International registration and results reporting
- Sharing results with participants
WHO international standards and criteria
The policy expectations described in this guidance document involve using registries acceptable by the World Health Organization (WHO). This approach has a wide range of expected benefits including international alignment and rigorous International Clinical Trials Registry Platform (ICTRP) registry standards that support data quality, as described below.
The WHO ICTRP strives to provide a publicly accessible and complete view of research. Their mission statement emphasizes: "The registration of all interventional trials is a scientific, ethical and moral responsibility."
The WHO ICTRP Registry Network allows information exchange and collaboration to establish best practices for clinical trial registration. This Network includes:
- data providers
- partner registries
- primary registries
- registries working with the ICTRP to become primary registries under its network
Learn more about ICTRP.
All primary registries must meet or be consistent with standards supporting criteria that fall under 6 main categories:
- content
- quality and validity
- accessibility
- unambiguous identification
- technical capacity
- administration and governance
As an example, under the content category, one criterion is that primary registries must be able to collect and publicly display the WHO Trial Registration Data Set. This is the minimum amount of information that must appear in a registry in order for a trial to be considered fully registered.
Primary registries must meet the minimum standards for all criteria as described in the WHO ICTRP document titled "International Standards for Clinical Trial Registries". They must also meet the requirements set by the International Committee of Medical Journal Editors (ICMJE), such as:
- public access at no charge
- being open to all prospective registrants
The ICMJE policy recommends that medical journal editors require registration of clinical trials in a public registry at or before the time of patient enrollment as a condition of consideration for publication. ICMJE uses the date trial registration materials were first submitted to a registry as the date of registration.
Learn more:
- WHO's international standards for clinical trial registries
- ICMJE's policy for registering clinical trials
Search portals and inventories
- ISRCTN search portal (BioMed Central)
- WHO ICTRP search portal (WHO)
- ClinicalTrials.gov search portal (US National Library of Medicine, National Institutes of Health)
International registration and results reporting
- Declaration of Helsinki (World Medical Association)
- Consolidated standards of reporting trials (CONSORT)
- International clinical trials registry platform (WHO)
- Clinical trials registration (ICMJE)
- General considerations for clinical studies, ICH E8(R1), Chapter 6.3 study reporting
ClinicalTrials.gov
- Investigator's login page
- Protocol registration quality control review criteria
- Protocol Registration and Results System user guide
- Study record manager's training and support materials
ISRCTN
- Register a study - you may select the registration or results reporting tab
- Further guidance