Annex 1 Revisions: Understanding the Implications of European Commission's Updates

  •  5/30/2023 07:08 AM

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?

  •  11/13/2020 02:14 AM

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?

  •  11/5/2020 05:48 AM

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?

  •  11/5/2020 05:40 AM

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?

  •  11/5/2020 05:38 AM

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?

  •  11/5/2020 04:25 AM

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?

  •  11/5/2020 04:19 AM

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?

  •  11/5/2020 04:12 AM

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?

  •  11/5/2020 04:03 AM

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?

  •  11/5/2020 03:51 AM

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?

  •  11/5/2020 02:17 AM

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?

  •  11/5/2020 02:13 AM

No, WHO does not maintain its own registry so you cannot register your trial directly with us.