- Registry URL: http://www.isrctn.org
- Registration URL: http://www.controlled-trials.com/isrctn/submission
- Funding Agency: The Registry is funded through a fee per trial paid by trial detail providers.
- Managing Agency: The Registry is owned by ISRCTN - a not-for-profit organization. The scheme is administered on behalf of ISRCTN by Current Controlled Trials Ltd.
ISRCTN is a not-for-profit organization with Directors, Members and Member Organizations.
- Does the Registry accept prospective registration of interventional clinical trials submitted by Responsible Registrants?
- Does the Registry have documented Standard Operating Procedures (SOPs)?
- Are mechanisms in place to ensure compliance with these SOPs? (eg staff training)
- Description of the compliance mechanisms:
The ISRCTN Register is managed by Current Controlled Trials Ltd, which is part of a scientific publishing group. Staff are therefore kept informed of the issues surrounding trial registration, e.g. journal requirements, concerns surrounding publication bias and tracking of results publications, from direct contact with colleagues. Staff also attend internal training and external conferences to improve their understanding of trial registration principles and to keep abreast of the developments in related fields. The quality of data hosted in the trial records are monitored by regular statistical and qualitative analyses. SOPs are reviewed and updated on a regular basis to reflect recent developments in the field of trial registration and changes in the internal procedures.
- Does the Registry agree to participate in the development of Guidelines for Clinical Trial Registers?
- Can the Registry collect and publicly display the WHO Trial Registration Data Set (TRDS)?
Yes, Click here to view the details.
- Languages in which the registered information is displayed:
- What quality control measures does your Registry have in place to make sure that all 20 items in the WHO TRDS are as complete and accurate as possible?
At the application stage, it is compulsory for trial applicants to provide all 20 data items. ISRCTN verifies that content is provided for all fields and that the content is applicable. If all the information is not provided, the trialist is contacted and the reasons why are recorded.
- Does the Registry flag trials that do not provide the complete WHO Trial Registration Data Set at the time of initial registration?
- Does the Registry agree to submit the WHO Trial Registration Data Set, in English, to the Central Repository?
- Does the Registry agree to keep registered information up-to-date?
- Does the Registry agree to maintain a publicly accessible audit trail so changes made to the WHO Trial Registration Data Set can be tracked?
Yes, audit trail information contained in the records themselves
- Does the Registry agree to never to remove a trial once it has been registered?
- Does the Registry publicly disclose ownership, governance structure and not/for-profit status?
- The web address where this information is displayed:
- Does the Registry agree to inform the WHO ICTRP Secretariat of changes that may be relevant to its status as a Collaborating Registry in the Registry Network?
In January 2007, the ISRCTN agreed to join the Registry Network on the following basis: (1) ISRCTN data is made available as is; (2) WHO ICTRP Secretariat has been made aware of the possible differences between the 20 items list and the current structure of the ISRCTN Register; (3) ISRCTN will continue to modify/improve its structure and processes in order to meet its objectives and will let the WHO ICTRP Secretariat know of any major development.
- Is the Registry searchable over the Internet at no charge?
- Is the Registry open to all prospective registrants?
- From which countries will the Registry accept trials for registration?