Welcome
Support Centre
01 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

ISRCTN: Frequently asked questions

The following FAQs are intended to provide further information about the ISRCTN Register. If you have never registered an ISRCTN before, it may help you to read through this document to ensure that your ISRCTN can be assigned quickly and efficiently:

What is the aim of the ISRCTN scheme?
What is the ISRCTN Register?
Who owns the ISRCTN Register?
What are the benefits of ISRCTN trial registration?
Can I publish my study protocol in one of BioMed Centrals journals?
What trials are eligible for an ISRCTN?
Who is responsible for obtaining an ISRCTN?
Can an organisation set up an account with CCT?
How do I obtain an ISRCTN?
What information do I need to provide to obtain an ISRCTN?
When should a trial be registered?
How should the ISRCTN be used and cited?
What happens if a duplicate ISRCTN is assigned?
The 'last edited' date on my record has been changed, but I canít see any changes. Why has this date changed?
Should pilot studies be registered?
What happens when the pilot study becomes the main study?
How do I decide whether the trial requires more than one ISRCTN?
What is the relationship between the metaRegister of Controlled Trials and the ISRCTN Register?
 
What is the aim of the ISRCTN scheme?

The ISRCTN is a simple numeric system for the identification of clinical trials worldwide. The randomly generated, eight-digit ISRCTN is unique to a registered trial, thereby ensuring that the trial can be simply and unambiguously tracked throughout its lifecycle from initial protocol to results publication.

 
What is the ISRCTN Register?

The ISRCTN Register is a register containing a basic set of data items on clinical trials that have been assigned an ISRCTN. Records are never removed from the ISRCTN Register (except in cases of duplications), which ensures that basic information about trials registered with an ISRCTN will always be available. The ISRCTN Register complies with requirements set out by the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and the International Committee of Medical Journal Editors (ICMJE) guidelines, and complies with the WHO 20-item Trial Registration Data Set.

 
Who owns the ISRCTN Register?

The ISRCTN Register is owned by ISRCTN - a not-for-profit organisation. Current Controlled Trials (CCT) Ltd administers the scheme on behalf of ISRCTN.

 
What are the benefits of ISRCTN trial registration?
Registration with an ISRCTN allows you to:
  • Comply with international guidelines from the WHO, ICMJE and CONSORT organisation: ISRCTN is fully compliant
  • Register any trial and study design regardless of country or healthcare area: ISRCTN is open to all
  • Register trials in bulk or individually: ISRCTN offers convenience and flexibility to trialists and research funders/sponsors
  • Keep details of your research up-to-date: ISRCTN records can be freely updated on request, making sure they are not missed out by systematic reviewers
  • Link your trials to their results: Trial IDs can be quoted in article abstracts and indexed by PubMed, allowing publications to link back to their initial registration
  • Maximise exposure for your research: ISRCTN content is fully and openly accessible and feeds automatically into the WHO international trial search platform
  • Join a growing number of trialists and funding bodies using the ISRCTN including: The Department of Health in England and Wales, the UK Medical Research Council, the Wellcome Trust, the Canadian Institutes of Health Research
 
Can I publish my study protocol in one of BioMed Centrals journals?

The ISRCTN register is administered and published by BioMed Central which also currently publishes over 260 peer-reviewed open access journals. These journals include Trials and Pilot and Feasibility Studies, as well as the BMC series medical journals, which offer a platform for publishing both protocols and research articles relating to clinical trials

 
What trials are eligible for an ISRCTN?

The ISRCTN Register will provide ISRCTNs to any clinical trial designed to assess the efficacy of health interventions in a human population. This includes both observational and interventional trials.

 
Who is responsible for obtaining an ISRCTN?

It is recommended that the trial sponsor apply for an ISRCTN, as trial registration is often regarded as being the responsibility of the sponsor. However it is also possible for trial co-ordinators and/or investigators to apply. In particular, in the case of self-funded trials, the lead principal investigator (i.e. the individual named on the protocol with overall legal and scientific responsibility for the trial) should apply.

 
Can an organisation set up an account with CCT?

In order to expedite and streamline the process of registering a trial with an ISRCTN, CCT has the facility to open an institutional account with organisations that have registered a trial for an ISRCTN in the past. With this method of trial registration, trials belonging to a specific organisation can be registered immediately (pending any questions on the trial information) and can utilise either a monthly or pre-pay method of paying for trial registration, instead of waiting for each individual invoice to be paid before the trial can be registered.

This system also allows an easier method of keeping track of all trials registered by account holder, as a yearly report can be created and sent out on all trials registered within the year, thus taking any stress out of registering large volumes of trials. Other institutions that have opened accounts with CCT in the past include the World Health Organization, the Wellcome Trust, and the Canadian Institute of Health Research (CIHR).

If you are interested in setting up an institutional account, please contact the CCT Editorial Team.

 
How do I obtain an ISRCTN?

To apply for an ISRCTN, simply visit the CCT submission page and follow the instructions on how to apply. Once your application has been received, a member of the CCT Editorial Team will contact you with any questions on the details of your trial, and details of payment. Please visit the submission page for more details on the administration fee for the ISRCTN.

Once details of the record are satisfactory to all parties, and once the payment has been received, an ISRCTN will be assigned and the trial record immediately included in the ISRCTN Register. Submission of a trial record to the ISRCTN Register assumes that the sponsor (or lead principal investigator) has read and agreed to the terms outlined in the Letter of Agreement.

 
What information do I need to provide to obtain an ISRCTN?

The ISRCTN data set and field definitions required for a successful application are available.

 
When should a trial be registered?

A trial can be registered at any stage during its development. It is never too late or too early to register a trial. Trialists are encouraged, however, to register before patient enrolment begins. As the ISRCTN Register holds a system-generated date of application as well as the trial start and end dates, the records will show whether the trial was registered retrospectively or prospectively.

 
How should the ISRCTN be used and cited?

Information on how the ISRCTN should be used can be found in the Guidance Notes.

 
What happens if a duplicate ISRCTN is assigned?

In the event that two or more ISRCTNs have been assigned to a trial, please contact the CCT Editorial Team to inform them of this duplication. CCT will advise on the best solution and keep all relevant parties informed. ISRCTNs that are taken out of use will not be re-assigned to another trial.

 
The 'last edited' date on my record has been changed, but I canít see any changes. Why has this date changed?

The 'last edited' date is automatically updated whenever a record is reviewed by the CCT Editorial Team. As part of the commitment to ensure that the information held on the ISRCTN Register is up-to-date and correct, CCT constantly reviews older records to obtain the most accurate information. Sometimes records are reviewed but no changes are required, therefore the last edited' date will be updated when there no external changes to the record. If the edit involves a key ISRCTN field then a public audit trail is entered into the record along with the changes. For more information on updating an already registered ISRCTN record, please visit http://www.controlled-trials.com/isrctn/updating_record/.

 
Should pilot studies be registered?

Although not all pilot studies go on to become full trials, CCT recommends that pilot studies should be registered provided the study is designed to assess the efficacy of a healthcare intervention(s).

 
What happens when the pilot study becomes the main study?

If the pilot study has already received an ISRCTN, there is no need to make a new submission as long as the main study has the same participant(s) and intervention(s). A new ISRCTN is required if the trial will be studying different groups of patients (i.e. not the same participant[s] and intervention[s] as in the pilot study). Any further questions on whether the main study requires a new ISRCTN can be directed to the CCT Editorial Team.

 
How do I decide whether the trial requires more than one ISRCTN?

If the trial involves more than one randomisation but is regarded as a single trial by the sponsor, it requires only one number. However, if the trial involves separate randomisations for different types of participant(s), each part can be numbered separately. In this case, an ISRCTN will be assigned for each part, and investigators should ensure that the correct ISRCTN is used for the relevant part of the trial.

 
What is the relationship between the metaRegister of Controlled Trials and the ISRCTN Register?

The metaRegister and the ISRCTN Register are two separate databases. The metaRegister of Controlled Trials (mRCT) is a collation of registers, gathered from several sources such as the ISRCTN Register, ClinicalTrials.gov and other organisation-specific registers, which allows users to search all participating registers for trial for a one-stop shop benefit. The ISRCTN Register is one of the registers held in the mRCT.

 

If you have any further questions, please contact the CCT Editorial Team.

8 July 2014

Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.