NHS Trusts Clinical Trials Register
(6 February 2003)

This document has been prepared for NHS Trust Managers in England, and provides further information about the creation and maintenance of the NHS Trusts Clinical Trials Register and the assignment of International Standard Randomised Controlled Trial Numbers (ISRCTNs) to those randomised controlled trials for which research costs have been met by the NHS.

Background
There is longstanding recognition within the NHS of the importance of registering randomised controlled trials. In March 2001, the NHS Research Governance Framework placed on all research sponsors the responsibility for ensuring that all clinical trials done within the NHS are registered. Specifically, section 3.8.6 states that it is the research sponsor’s responsibility to ensure that: ‘Appropriate arrangements are in place for the registration of trials’.

The Research Governance Framework also states that principal investigators are responsible for ensuring that controlled trials are registered, and they can comply with the Research Governance Framework by ensuring that their sponsoring organisations have provided sufficient, accurate information about trials to meet the minimum data requirements for registration.

What is the NHS Trusts Clinical Trials Register?
The NHS Trusts Clinical Trials Register is a new register of randomised controlled trials carried out in England for which the research costs have been met by the NHS.

The register is being supported under a 3 year contract let by the Department of Health to assess the feasibility of this approach to the registration of these trials and the allocation of the ISRCTN.

Which trials will be included in the NHS Trusts Clinical Trials Register?
The NHS Trusts Clinical Trials Register is restricted to randomised controlled trials carried out in England, for which the research costs have been met by the NHS. Trials that are partially funded by the NHS and partly by any external non-NHS organisation will NOT be included in this register.

The NHS Trusts Clinical Trials Register will initially include ongoing trials that have an end date later than 31 March 2003. Trials that stop recruiting, or which are completed, in follow-up or terminated after that date will continue to be listed in the NHS Trusts Clinical Trials Register.

(It may also be helpful to note that trials funded by the NHS Research and Development Health Technology Assessment (HTA) Programme will have their own register. Allocation of ISRCTNs to HTA trials will be carried out by Current Controlled Trials under a separate scheme supported by the Department of Health.)

How will the trial information required for inclusion in the NHS Trusts Clinical Trials Register be collected?
The trial information will be obtained from the records submitted to the National Research Register (NRR).

What information will be displayed in the NHS Trusts Clinical Trials Register?
A minimum data set, derived from the NRR data items, will be displayed for each trial. This data set provides the basic information that the Current Controlled Trials Ad Hoc Group for Prospective Registration of Controlled Trials considered essential for clinicians, patients and researchers to identify trials that may be of interest.

What about completed/terminated trials?
Trials that have an end date on or before 31 March 2003 will not be included in the NHS Trusts Clinical Trials Register. Trials that stop recruiting, or which are terminated after this date will continue to be listed in the NHS Trusts Clinical Trials Register.

Will the trial records collected by the NRR be edited?
Records of trials for which the research costs are met by the NHS in England and which are submitted to the NRR, will be edited and tagged (for disease/condition and intervention) by the Current Controlled Trials editorial office. Specific queries on individual trial records will be brought to the attention of the relevant NRR data provider by Current Controlled Trials, and changes will be made to the records as appropriate. Any changes to the trial records will then be fed back to NRR data providers to ensure that they amend their records locally and submit updates to their amended record to the NRR.

When will the NHS Trusts Clinical Trials Register be available?
Data collection for the NHS Trusts Clinical Trials Register will start by filtering the records submitted to the NRR in March 2003 (NRR issue 2 2003). It is expected that the NHS Trusts Clinical Trials Register should go live by Summer 2003.

How often will the trial records be updated?
The records in the NHS Trusts Clinical Trials Register will be updated annually, using the data collected each March by the NRR.

How will the trial records be updated?
The NRR routinely asks data providers to update their records on a quarterly basis. The NHS Trusts Clinical Trials Register is updated annually, using the data collected each March by the NRR.

Where will the NHS Trusts Clinical Trials Register be located?
The NHS Trusts Clinical Trials Register will be included in the metaRegister of Controlled Trials.

Will access to the NHS Trusts Clinical Trials Register be free?
Yes. There will be no charge for users to access the NHS Trusts Clinical Trials Register. Users are simply asked to complete a registration form in order to be able to view the trial records in the metaRegister of Controlled Trials.

What is the International Standard Randomised Controlled Trial Number (ISRCTN)?
The ISRCTN is a new system for the unique identification of randomised controlled trials worldwide. Intended to act rather like the ISBN for all books, the ISRCTN will simplify the identification of trials and help to track all publications and reports resulting from each trial.

Who will assign the ISRCTN to the individual trial records?
Current Controlled Trials is responsible for checking all trial records to ensure that no duplicate ISRCTNs are assigned. Once this check has been completed, an ISRCTN will be assigned to each trial. Current Controlled Trials will ensure that the relevant NRR data providers, lead principal investigators and the NRR are informed of ISRCTNs.

How will the NRR data providers get to know the ISRCTN that has been assigned to their trials?
Current Controlled Trials editorial office will inform the relevant NRR data providers, lead principal investigators and the NRR when an ISRCTN is assigned to a trial.

What is the relationship between the metaRegister of Controlled Trials and the ISRCTN Register?
The metaRegister of Controlled Trials and the ISRCTN Register are two separate registers, maintained by Current Controlled Trials Ltd.

The metaRegister of Controlled Trials is an international database combining registers of ongoing randomised controlled trials in all areas of healthcare. The ISRCTN Register is a database of randomised controlled trials with International Standard Randomised Controlled Trial Numbers (ISRCTN).

Who is responsible for creating and maintaining the NHS Trusts Clinical Trials Register?
Current Controlled Trials Ltd is responsible for creating and maintaining the NHS Trusts Clinical Trials Register.

Who can I contact for further information?
Please contact the Current Controlled Trials editorial office if you have any questions regarding the NHS Trusts Clinical Trials Register.