International Standard Randomised Controlled Trial Number (ISRCTN): required data items

A list of the required data items for an ISRCTN application is given below. For more information, a table of the required data fields and how they comply with the WHO/ICMJE requirements is also available.

Applicant details
The person making the application, can be contacted should there be any query on the application.

Sponsor details
The organisation taking primary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting.

Lead principal investigator/contact details
The individual with legal and scientific responsibility for the trial, even if it is a multicentre trial.

Trial details

• Protocol/serial number
• ClinicalTrials.gov identifier (if available)
• Public title
• Scientific title
• Acronym (if available)
• Study hypothesis
• Ethics approval
• Study design
• Countries of recruitment
• Participants - inclusion criteria
• Participants - exclusion criteria
• Patient information material
• Target number of participants
• Anticipated start date (dd/mm/yyyy)
• Anticipated end date (dd/mm/yyyy)
• Disease, condition or study domain
• Interventions
• Primary outcome(s)
• Secondary outcome(s)
• Trial website (if available)
• Publications (if applicable)
• Sources of funding

Note: Sponsors and lead principal investigators may request that telephone, fax and email are not displayed in their records, but are asked to provide these for administration purposes if at all possible.

December 2007