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. The data set of items in the online application form is divided into four different sections:

SECTION 1: Applicant details
These details will be automatically taken from the registration form when you first log in. The applicant should be the individual who will be responsible for the registration, including answering any questions the CCT Editorial Team have on the application, and providing details of where the invoice should be sent. Applicant details will not be publicly available once the record has been made live on the ISRCTN Register.

SECTION 2: Trial details
A list of field definitions is available for further information on these main fields and the type of information required for a successful application:

• Protocol/serial number
• ClinicalTrials.gov identifier (if available)
• EudraCT number (if available)
• Public title
• Scientific title
• Acronym (if available)
• Study hypothesis
• Lay summary
• 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 measure(s)
• Secondary outcome measure(s)
• Trial website (if available)
• Publications (if applicable)
• Sources of funding

SECTION 3: Sponsor details
This is 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. If you have two or more joint sponsors for your trial, please enter the main (primary) sponsor details in this section and add the other details into the interventions section of the trial details, under a relevant title (e.g., secondary sponsor details, joint sponsor details, etc.,). Sponsors may request that the telephone, fax and email details are not displayed in their records, but are asked to provide these for administration purposes.

SECTION 4: Contact details
This is the individual with legal and scientific responsibility for the trial, even if it is a multicentre trial. If you have separate public and scientific contact details, then please enter the public details in this section and add the scientific contact details into the interventions section of the trial details, under a relevant title (e.g., scientific contact details). Contacts may request that the telephone, fax and email details are not displayed in their records, but are asked to provide these for administration purposes.

18 December 2012