ISRCTN Guidance Notes

The following documentation provides information on how and when to use the ISRCTN assigned to your trial.

How should the ISRCTN be used?

• When quoting the ISRCTN, please make sure that no space is inserted between the ISRCTN and the actual number
• Where practical, the ISRCTN should be used in all aspects of trial management and documentation. It should be referenced in all new material relating to the trial and used in future correspondence, reports and publications.
• If the trial is registered within an existing specialist register, the ISRCTN should also be quoted. This will aid in de-duplications between registers.
• The ISRCTN should be retained, even if there are alterations to the protocol, the investigators or the funding body
• In the event that a trial has been allocated more than one ISRCTN (for example if it has been registered by two separate individuals, or has been allocated a number from two distinct organisations), one will be withdrawn. You will be notified of this change.
• ISRCTNs that are taken out of use will not be re-allocated to another trial
• The ISRCTN does not replace the trial acronym. Nor is the trial acronym a replacement for the ISRCTN. They should not be used interchangeably.

ISRCTN checklist for investigators
Once your trial has been assigned an ISRCTN, please ensure the following actions are taken:

• Record the ISRCTN on the master copies of all trial documentation (e.g. protocol, trial forms, patient leaflets, reports, etc.,)
• Make arrangements to use the ISRCTN in publications, conference presentations, correspondence relevant to the trial and references to the trial (e.g. new grant applications)
• If the trial is registered on a specialist trial register, inform the register co-ordinator of the ISRCTN
• Notify funding bodies, other than that which assigned the ISRCTN, if they are co-funding the trial
• Notify other sponsoring partners (e.g. companies supplying drugs or other materials to the trial, overseas co-operating or collaborative partners etc.,)

When/how to update a record
The ISRCTN Register does not insist on regular updates to a trial record but will regularly review the content and get in touch with the contact listed. If the trial end date has been altered or if your trial has evolved substantially since ISRCTN registration, please use the updating record page to contact CCT and have the record amended accordingly.

Publications
If you publish an article that is directly reporting on either the protocol or results of your trial, then it is always preferable to quote your ISRCTN in the manuscript. Many journals are now insisting on trial registration prior to manuscript submission so you may find that there is a specific rule for the journal you are submitting to. You do not need to inform CCT of the publication of your results, as the CCT Editorial Team should pick up on this as soon as your manuscript has been published and listed on PubMed. However, if your publication has not been added to the record two weeks after appearing in PubMed, please contact the CCT Editorial Team.

For any other questions on how to use the ISRCTN, please contact the CCT Editorial Team.

May 2008