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.

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.
• Information in the ISRCTN register is not required to be updated on a regular basis, although updates can be made to trial information when requested by Sponsors/lead principal investigators, and when trial reviews are performed by the administration team of Current Controlled Trials Ltd.
• 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.

2.  ISRCTN

• ISRCTN will provide a suitable, efficient web searchable database for the ISRCTN Register.
• ISRCTN will not be expected to provide an answer service in relation to 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.

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
Contact details for the ISRCTN Register are provided below:

Anne Greenwood and Hélène Faure
ISRCTN
c/o Current Controlled Trials Ltd
Middlesex House, 34-42 Cleveland Street
London W1T 4LB, UK

Tel: + 44 (0) 20 7323 0323
Fax: + 44 (0) 20 7580 1938
Email: info@isrctn.com

September 2006