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Annex 1 Revisions: Understanding the Implications of European Commission's Updates
Annex 1 of the European Union GMP document provides specific guidance on the production of sterile medicinal products, covering various aspects such as facilities, equipment, validation, environmental monitoring, and personnel. Its aim is to establish a harmonized approach to ensure the highest quality standards throughout the manufacturing process.
What is the Solidarity Trial?
The Solidarity Trial is an international clinical trial to help find an effective treatment for COVID-19, launched by WHO and partners. It is hoped that one or more of the treatments under trial will result in improving clinical outcomes in COVID-19 patients and save lives. Other trials are on-going around the world in addition to the Solidarity Trial.
What should I do if I want to take part in clinical trial?
If you are patient or family member and you find a trial that is of interest we suggest that you print out the information and discuss it with your health care provider. They should be able to advise you on the appropriate course of action.
How does a registry become a primary registry in the WHO registry network?
The ICTRP is a country-led initiative. Clinical trial registration happens when countries seek to improve the transparency of clinical trial research involving nationals of that country, and to be more accountable to the individuals who consent to participate in clinical research, and to better oversee and monitor that research.
What is a Primary Registry?
A Primary Registry in the WHO Registry Network is a clinical trial registry with at least a national remit that meets WHO Registry Criteria for content, quality and validity, accessibility, unique identification, technical capacity and governance and administration.
How does the ICTRP support countries and regions?
If an agency in a member state (such as a Ministry of Health or a National Regulatory Authority) is interested in establishing a new clinical trial registry that complies with WHO criteria (or improving an existing registry), or in establishing policies that require registration in an existing Primary Registry.
What does the ICTRP do?
Publishes the ICTRP Search Portal, Supports the WHO Registry Network and Supports countries and regions wanting to establish WHO-compliant clinical trial registries or policies on trial registration.
What is trial registration?
WHO regards trial registration as the publication of an internationally-agreed set of information about the design, conduct and administration of clinical trials. These details are published on a publicly-accessible website managed by a registry conforming to WHO standards.
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
How many times should a trial be registered?
To meet WHO requirements for transparency and publication it is only necessary for your trial to be to registered once, in either a Primary Registry or an ICMJE approved registry.
What information about clinical trials needs to be registered?
The minimum information that must be registered is specified in the WHO Trial Registration Data Set. Individual registers may request more information than this (e.g., study sites).
Can I register with the WHO IC TRP?
No, WHO does not maintain its own registry so you cannot register your trial directly with us.