Letter of Agreement between ISRCTN and sponsors (or lead principal investigators/data providers)

Introduction
The ISRCTN scheme is a simple numeric system for the unique identification of randomised controlled clinical trials worldwide.  The ISRCTN Register will also accept registration of other forms of studies designed to assess the efficacy of healthcare interventions. 

The ISRCTN Register is a database containing the records of all the trials that have been assigned an ISRCTN.  The ISRCTN Register is owned by ISRCTN, a not-for-profit organisation, and is administered on behalf of ISRCTN by Current Controlled Trials Ltd.  The ISRCTN Register is a separate register from the metaRegister of Controlled Trials.

This document sets out a number of central points so that both sides will know what is expected of them under the scheme.

Submission of data

1. It is usually the responsibility of the sponsor to apply for an ISRCTN. However, it is also possible for trial coordinators and/or the lead principal investigator or main data provider to apply.
2. The sponsor/lead principal investigator/data provider must supply some essential data items about the trial before an ISRCTN can be issued. The information supplied about the trial will be displayed in the ISRCTN Register. (Sponsors and lead principal investigators may choose not to have certain contact details displayed.) All users will have permanent free access to the information in the ISRCTN Register.
3. An administrative charge is made for the costs associated with assigning ISRCTNs to trials. This charge may be waived for trials from developing and transitional countries.
4. Please note that once a trial has been registered on the ISRCTN Register and publicly displayed on the website, the study will remain permanently on the register and cannot be deleted.

Responsibilities

1.  Sponsor/Lead Principal Investigator/Data Provider

• Sponsors/lead principal investigators/data providers are expected to supply information about only those trials that have been approved by the appropriate scientific, ethical and regulatory bodies.
• Sponsors/lead principal investigators/data providers will need to provide some essential data items when submitting a trial to the ISRCTN Register.
• The quality and accuracy of the data supplied are the responsibility of the sponsor/lead principal investigator.
• A contact name for each trial will be required to handle follow-up questions.
• After registration, the data provider can request a record update at any time by following the updating record procedure.

2.  ISRCTN

• ISRCTN will provide a suitable, efficient web searchable database for the ISRCTN Register.
• The ISRCTN Register will be managed so as to cause no public relations, ethical or political problems for researchers.
• ISRCTN will monitor data submission and quality.
• ISRCTN will make all reasonable provision to ensure that the website is secure and that data are available on a 24 hour 365 day basis subject to necessary down time for the maintenance of systems and upgrading of software.
• ISRCTN will arrange for the ISRCTN Register to be registered with the Data Protection Act Registrar.
• After registration, the ISRCTN Editorial Team will contact the data provider at regular intervals to make sure that the data is kept up-to-date.

Standards
The ISRCTN Register aims to provide unambiguously identified information about randomised controlled trials in healthcare and to maintain high standards of data quality and presentation.  In addition to randomised controlled trials, the ISRCTN Register will also accept registration of other forms of studies designed to assess the efficacy of healthcare interventions.

Ownership

1. Data in each trial record are owned by the organisation/individual submitting them.
2. The ISRCTN Register is owned by ISRCTN - a not-for-profit organisation.
3. ISRCTN will be responsible for and will arrange for all third party software licences to be secured.

Management
ISRCTN is managed by an independent Board of Directors.

Points of contact
For further information, please contact the ISRCTN Editorial Team or write to:

ISRCTN c/o Current Controlled Trials Ltd
Floor 6, 236 Gray's Inn Road
London WC1X 8HL, UK
Tel: +44 (0) 20 3192 2000(switchboard)

May 2011