Memorandum of Understanding between Current Controlled Trials Ltd and Research Funders (and others supplying registers to the metaRegister of Controlled Trials)

Introduction
As part of an initiative to improve knowledge of past, current and emerging controlled trials throughout the world, Current Controlled Trials Ltd (part of the Science Navigation Group) has established a web-based metaRegister of Controlled Trials (mRCT). Details of the preliminary proposal were contained in a paper presented to a meeting held on 29^th July 1998 at the UK Cochrane Centre, Oxford. Click here to view a report of the meeting. Current Controlled Trials Ltd made a commitment to provide free and open access to information about ongoing randomised controlled trials, and this has remained the guiding principle behind the company's activities.

Several organisations agreed to help Current Controlled Trials Ltd establish the prototype for the Current Controlled Trials website, which was launched in late 1998. This document sets out a number of central points so that all organisations will know what is expected of them by their partners.

Ownership

1.	Data submitted to mRCT will be owned by those organisations submitting the data.
2.	Current Controlled Trials Ltd will be responsible for and will arrange for all third party software licences to be secured; Current Controlled Trials Ltd will be the sole owner of any bespoke software created in the Current Controlled Trials website.

ISSN
The mRCT has been given the following International Standard Serial Number (ISSN 1467-1018).

Charges

1.	Current Controlled Trials Ltd will make no charge to users for browsing the mRCT and extracting data.
2.	Current Controlled Trials Ltd initially undertook to make no charge to research funders (and others) for depositing material in the mRCT (unless significant editing was required). Following the failure of Current Controlled Trials Ltd's recent bid for three years' funding from the European Union, Current Controlled Trials Ltd has revised its future strategy in consultation with its mRCT/ISRCTN international advisory group. Current Controlled Trials Ltd has decided it must look to trial sponsors and other register-holders to support the effort to provide information on ongoing trials free to the user. Further details of the revised strategy are available.

From October 2002, organisations wishing to include their trial register in the mRCT have been asked to contribute to the costs of processing, indexing and displaying the information and ensuring that it is available via the Current Controlled Trials website, free to the user. For information on the scale of charges, please contact info@controlled-trials.com.

Responsibilities

1. Research funders/register providers

• All research funders/register providers will be expected to supply information about only those controlled trials that have been approved by the appropriate scientific, ethical and regulatory bodies.
• Research funders/register providers will need to provide certain data items in order to become eligible for inclusion in the mRCT.
• The quality, currency and accuracy of data are the prime responsibility of the funding organisations/register providers.
• Information must be updated as frequently as possible, but at least every year, and the date of update should be visible.
• A contact name for each trial will be required to handle follow-up questions. Often this will be the Trialist. It is the responsibility of the research funder/register provider to ensure that the person named as the contact has given permission for his/her details to be displayed on the Internet.
• Should it be necessary, research funders/register providers will provide updates according to a schedule of deadlines agreed with Current Controlled Trials Ltd.

2. Current Controlled Trials Ltd

• Current Controlled Trials Ltd will develop and maintain a suitable, efficient web searchable database for the mRCT.
• Current Controlled Trials Ltd will not be expected to provide an answer service in relation to the mRCT – this will be the responsibility of research funders.
• The mRCT will be managed so as to cause no public relations, ethical or political problems for research funders.
• The mRCT is not intended for commercial promotion and advertising, but information on company support for trials or for the Current Controlled Trials website itself is permitted.
• Neither the ownership of the mRCT nor the data contained therein can be passed on to a third party without the unanimous permission of the research funders/register providers.
• To ensure that the site maintains its momentum, Current Controlled Trials Ltd will monitor data submission and quality.
• Current Controlled Trials Ltd will make all reasonable provision to ensure that the mRCT site 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.
• Current Controlled Trials Ltd will register the database with the Data Protection Act Registrar.
• Current Controlled Trials Ltd will undertake to deposit the mRCT (ISSN 1467-1018) in an electronic format, every year, with the five UK copyright libraries.
• Current Controlled Trials Ltd will develop other products on its site (in addition to mRCT), which will be owned by Current Controlled Trials Ltd.
• If at any time the site were to be wound up, the impact on users would be established in order to minimise damage. In any case Current Controlled Trials Ltd should provide at least 6 months' notice of termination of these arrangements.

Participating organisations will collectively provide publicity for the site as necessary taking account of the interests and sensitivities of Current Controlled Trials Ltd and other research funders.

Duration, review and exit arrangements
In the fast moving world of the Internet it is not productive to develop very long-term plans and commitments. Progress, use and value will be reviewed annually:

2001
2002/3

Standards
The mRCT is designed to be flexible and embracing; it aims to provide some minimum quantity of information about controlled trials and maintain high standards of data quality and presentation.

Management
An Advisory Group has been established to oversee the mRCT and International Standard Randomised Controlled Trial Number initiatives.

Issues, problems and escalation
As this is a voluntary arrangement it is expected that there will be few difficulties after any setting up issues have been resolved. The Current Controlled Trials Ltd Managing Director Anne Greenwood should be the first point of contact to resolve issues, followed if necessary by discussion with the Advisory Group. Only in extreme circumstances will research funders/register providers as a body be asked to intervene.

Points of contact
Each organisation should provide one lead name with contact details.

October 2002