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ISRCTN documentation
– for guidance only
The following
documentation provides some background on the ISRCTN scheme and is a reminder
of how to use the ISRCTN that has been assigned to your trial.
Background notes
What is the ISRCTN?
The growth in prospective registration of clinical trials has accentuated
the need to distinguish between different trials. Trials are usually referred
to by a series of grant numbers, protocol numbers, trial names and acronyms
which can make it difficult to determine whether reports, publications or
entries in trial registers refer to the same trial or not. To provide an accurate
reflection of the research activity in a particular area it is important that
each trial is counted only once and that unintended duplication between registers
is avoided.
The ISRCTN scheme is a simple numeric system for uniquely identifying
randomised controlled trials worldwide, which will enable clinicians, researchers,
funding organisations and members of the public to recognise individual trials
more easily. In addition, the ISRCTN Register now also accepts registration of other forms
of studies designed to assess the efficacy of healthcare interventions.
The ISRCTN scheme works in much the same way as the ISBN system for labelling
and identifying books internationally. The ISRCTN is a randomly generated,
8-digit number, prefixed by the code ISRCTN that uniquely identifies each
trial in the ISRCTN Register.
The ISRCTN should be quoted in all publications relating to the trial, in
order to:
- Clearly
identify the trial and prevent mistaken identity
- Help
to detect duplication in current registers of trials, and to avoid trial
double-counting when assessing a field of research activity
- Enable
tracking of the trial from inception to completion, and beyond
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, used in future correspondence, reports and future publications.
- If
the trial is registered within an existing specialist register, the ISRCTN
should also be quoted. This will allow those searching registers to identify
quickly and reliably duplicates 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:
- File
the original notification of the ISRCTN.
- Record
the ISRCTN within your own database(s) where applicable.
- Record
the ISRCTN on the master copies of all trial documentation (protocol, trial
forms, patient leaflets, reports, etc…) .
- Make
arrangements to use the ISRCTN in publications, conference presentations,
correspondence relevant to the trial, references to the trial (e.g. new grant
applications).
- Notify
your clinical centres of the ISRCTN.
- 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…).
Example
of standard letter
This example can be used to notify clinical centres, co-funders and co-sponsors
of the ISRCTN assigned to your trial.
(Address)
Notification of ISRCTN
Dear (Contact Name)
The following trial (Insert trial title) has
been assigned a unique trial identification number, the ISRCTN. This number
is:
Insert ISRCTN (ISRCTN prefix + 8 digits, with
no space)
These identification numbers are being issued to randomised controlled trials
(RCTs) and trials assessing the efficacy of healthcare interventions as part
of a scheme that aims to ensure that an individual trial can be uniquely identified.
The numbers are recorded publicly in the ISRCTN Register on
http://isrctn.org
A lot of effort is currently wasted in trying to trace different records
of the same trial, and to distinguish between different trials with similar
names or acronyms. The unique ISRCTN helps reduce duplication of trial records
and eliminate duplication of trials between trial registers.
The scheme has the full support of your funder [name
of the funding body that assigned the ISRCTN].
We ask you to quote this number (including the prefix ISRCTN), in all future
reports, correspondence, publications, abstracts, conference presentations
concerning the trial including:
- Correspondence
with organising bodies and funding bodies
- Future
entries on registers
If
you have any questions or queries regarding the ISRCTN scheme, or the issuing
of the number, please contact (Name and contact details of an appropriate contact within the organisation) or contact
info@isrctn.com
Best wishes
(Name of PI or trial co-ordinator)
For further information about the ISRCTN scheme and to become involved,
please visit the ISRCTN Register website at http://isrctn.org. Alternatively,
please contact info@isrctn.com
January 2006
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