Definitions

For guidance on filling in the ISRCTN study registration form, please refer to the relevant terms below (listed alphabetically).

Where “(WHO)” is displayed, this indicates that the data is required by the World Health Organisation (WHO) as one of the 20 items that must be included in a clinical trial record for the trial to be considered fully registered.

Please note that, once you have submitted your study for registration, it enters our in-house editorial system and you will no longer be able to make changes to the record yourself. If you would like any changes to be made after submission, please email us at info@isrctn.com quoting your study ID, and we will do this for you on your behalf.

Acronym (WHO)

An acronym refers to an abbreviation of your scientific title. This can be made up from individual letters from your title or parts of a word from your title. Alternatively, you can supply a short name you use to refer to your study.

Example of acronym: ECHO (Evidence for CHildren's Outcomes).

ClinicalTrials.gov number (WHO)

If your study is also registered in the ClinicalTrials.gov database, enter the number assigned to your study here. The format is NCT12345678.

Condition (WHO)

Please provide a short description (maximum one sentence) of the disease, condition or healthcare domain being studied. If you would like to add more information on the disease being studied, then this information can be placed in the hypothesis section.

Examples:
Cardiovascular disease
Cardiovascular disease and co-morbid type 2 diabetes

Contact Email

If possible, we would prefer that you supply a professional, or work-based, email address.

Contact ORCID ID

An ORCID ID is a unique digital code for researchers that can be used to identify all their publications and grant applications. If you do have one, please enter it here. If not, and you are interested in obtaining one, you can go to the ORCID website for further information.

Contact Privacy

Study contacts may request that the telephone number and email are not displayed in the public trial record by selecting "Hide telephone and email details" option from the drop down.

Contact type (WHO)

The contact for public queries is the person who will respond to general queries, including information about current recruitment status. The contact for scientific queries is the person who will respond to scientific queries about the study. You can add another contact by clicking on "Add another contact".

Countries of recruitment (WHO)

Please select all the countries where recruitment for the study is expected to take place. If you are registering a study taking place in the UK, it may be eligible for inclusion in the NIHR portfolio database. Please click here for further information.

Drug name(s)

Many studies involve the administration of a new drug, supplement or other substance. Please enter the name of any substances being administered here. You must complete this field if you have described your intervention type as a drug or supplement.

Ethics approval

In general, any research that involves human participants, human tissue or human data should obtain ethics approval before it begins, but regulations will vary from one country to another. Please provide details of the full name of your ethics board (providing an English translation of the name if appropriate), the date of approval, and any reference numbers attached to this approval. For a multi-centre study, please provide the details for your lead centre only. For international studies, if you have a lead centre in each country then please provide details for each lead centre. All other centres can be covered with the blanket phrase 'All other centres will seek ethics approval before recruitment of the first participant.' If you have no ethics approval yet, then please enter details of when and with whom you plan to submit. If your study does not require ethics approval, please tell us why. See example.

EudraCT number (WHO)

If your study is also registered in the European Clinical Trial (EudraCT) database and you have a unique EudraCT number, enter it here. The format is YYYY-123456-78.

Funder Name (WHO)

All studies need funding even if they are self-funded. Please list all the funders for this study, providing an English translation for names of institutions/organisations as appropriate. You can use the FundRef functionality to select the names and contact details of major funders. If the name of your funder does not appear in the list, input it manually. You can add another funder by clicking on "Add another funder".

Intention to publish date

Please give an indicative date for when you intend to publish the protocol and results of your study.

Interventions (WHO)

The intervention refers to the treatment or action tested in your study. Please enter the names of all treatments or actions, including the control (enter 'placebo' or 'no treatment' as applicable) and how participants are randomised into the different arms, if applicable. Describe other details of the interventions as applicable (dose, duration, how it is administered etc.).

For observational trials, please provide a brief summary of your methodology, providing details of any tests to be run, observations made and other pertinent information.

Intervention type

Please select the intervention type from the drop-down that most accurately describes that used in your trial. Options are as follows:

  1. Drug: A chemical substance used as a medicine and recognised in an official pharmacopeia. Examples would include antibiotics and drugs used in chemotherapy
  2. Supplement: A product that has been developed to supplement the diet but are not in themselves considered food. Examples would include minerals, herbs and amino acids
  3. Device: This includes instruments, apparatus, machines or implants, for example, surgical lasers, hearing aids and MRI equipment
  4. Biological/Vaccine: Biological products used as medicines. This includes vaccines, blood and blood products, and human cells and tissues used for transplantation
  5. Procedure/Surgery: Invasive or external procedures/therapies or external therapies used in medical treatment
  6. Behavioural: Treatment that is designed to modify a person’s behaviour. This includes behavioural therapies, group therapies and relaxation techniques
  7. Genetic: This includes gene therapies introducing DNA into a patient's cells to treat a disease
  8. Mixed: Please select this option if multiple types of intervention are used
  9. Other: Please select if intervention is different to any listed above.
Overall trial end date

The end date of your study should be stated in your study protocol. In many cases, it is expected to be the last date that data is collected. Please give the anticipated or actual end date for the study in the format dd/mm/yyyy.

Overall trial start date

A study starts when you begin planning the design of the study and developing the protocol. The overall start date should precede the recruitment start date as the overall study period includes the recruitment period. Please give the anticipated or actual start date for the study in the format dd/mm/yyyy.

Participant exclusion criteria (WHO)

Participant exclusion criteria are characteristics that exclude potential participants from taking part in the trial. Use a numbered list with a new line for each exclusion criterion.

Participant inclusion criteria: Age (WHO)

Please select the age range of your participants from the inclusion criteria, according to the following guidelines:

  • Adult: Aged between 18-65 years
  • Senior: Aged 66 or over
  • Neonate: Newborn up until 28 days of age
  • Child: Aged between 29 days and 17 years
  • All: People from all age ranges
  • Mixed: People from two or three different age groups. For example, in this case both mothers (adults) and neonates take part in the study
  • Other: Please select if age range is different to that of any of those listed above
Participant inclusion criteria: Description (WHO)

Describe all the characteristics that all potential participants must have to take part in the study, including age range and gender. Use a numbered list with a new line for each inclusion criterion.

Participant inclusion criteria: Gender (WHO)

Please select the gender of the participants taking part in your study from the drop-down.

Participant inclusion criteria: Participant type (WHO)

Participant inclusion criteria are a list of characteristics that all potential participants must have to take part in the study.

Please select the type of participant taking part in this study from the following options:

  • Healthy volunteer: Healthy volunteers who fulfil the inclusion criteria for a trial
  • Patient: Volunteers who have the disease or condition that is being studied
  • Health professional: Volunteers who work in the healthcare sector. This includes, for example, medical doctors, dentists and nurses
  • Carer: Volunteers who care for someone with a disease or condition in a domestic environment (for example, a person's home)
  • Mixed: Please select this option if participants are of more than one type (for example, if comparing healthy volunteers with patients)
  • All: Please select this option if participants of every type specified in the list take part in the study
  • Other: Please select if your participant inclusion criteria is different to any of those listed above
Participant inclusion criteria: Target number of participants (WHO)

This is the target total recruitment of participants for the trial (across all arms and all sites if a multicentre trial). If your study is a cluster randomised controlled trial, please include the number of clusters and how many participants are included in each cluster.

Participant information sheet

The participant information sheet (PIS) is an information sheet for people who are taking part or have shown interest in taking part in a study.

It should state the aims of the study and what the participants will be asked to do in plain English.

Please include the URL if it is web-based or downloadable from an internet site.

If you wish to make your PIS only accessible to the participants taking part in the trial, please write "Not available in web format, please use contact details to request a participant information sheet".

Participant level data

A growing number of journals encourage authors to make materials they describe in their study protocols (e.g. participant-level data from clinical trials) freely available to any scientist wishing to use them, in accordance with relevant guidance and legislation on data protection and participant confidentiality (see BioMed Central’s policy). The purpose of this field is to build up evidence on plans regarding the availability of participant-level data (sometimes referred to as raw data). Please select an option as appropriate from the drop-down:

  • Available on request
  • Not expected to be made available
  • Stored in repository
  • Other
Payment method

After your study registration has been submitted, it will be curated by our in-house editorial team. Once the editorial process is complete, you will be required to pay a one-off fee of GBP 214 +VAT when applicable (from 09/01/2017: GBP 220 +VAT when applicable) for the study to be registered with an ISRCTN and published online. This fee helps to cover the cost of editing and curation, data conversion, and permanent online hosting.

Please select the method of payment for registration of this study from the drop-down. The options are as follows:

  • Online payment: Please select if paying by debit or credit card. We would recommend that you choose this option if possible as this is the fastest method of payment. Your ISRCTN is assigned to your study immediately upon receipt of payment. Receipts will be emailed to you shortly after the payment has been made.
  • Offline payment: Please select if you wish to pay by bank transfer or cheque, or if you require an invoice or purchase order. Please note that bank transfer payments can take up to 30 days to process and a cheque can take up to 15 days. Offline payments also carry an administrative surcharge of GBP 20.
  • Funder pays: Please do not select this option unless you know that your funder has arranged an agreement with ISRCTN to pay for the registration directly (i.e. NIHR, HTA or Wellcome Trust).
Phase (WHO)

Drug trials are commonly carried out in a series of stages or phases. If your study is a drug trial, please select which option is appropriate from the drop-down.

  • Phase I: These involve only small numbers of people and they are used to find out the safe dose range for the drug and test for side effects
  • Phase II: These involve a larger number of people than phase I and the aim is to get an idea of whether the drug works in the short term and how well it works
  • Phase I/II: These studies test the drug's general safety and appropriate dosage levels, and how well the drug works in the short term
  • Phase III: This is the stage when a large scale, randomised clinical trial takes place, where the drug being tested is compared to that of another well-established treatment and/or a placebo. The effect of the new drug on the disease being studied, its side effects and any possible longer-term effects that may develop are investigated
  • Phase II/III: In these trials the effect of the new treatment and the effectiveness of the treatment compared with another well-established treatment and/or placebo are investigated
  • Phase IV: These take place once the new drug has been given its marketing licence, meaning that it is now available for prescription. The safety, side effects and effectiveness of the drug is monitored while it is being used in clinical practice
Plain English Summary

The plain English summary describes your research to the lay public and should be written in easily understood plain English in under or around 1000 words. It should encapsulate your research and is the first item listed on a registered study record. We ask that you present the information under the following headings:

  • Background and study aims (brief description of the disease or area of study, what are the objectives/aim of the study)
  • Who can participate? (what are the age range and gender of the participants, can they only participate if they have a certain condition or if they are healthy volunteers?)
  • What does the study involve? (what interventions will be compared, will all participants receive the same treatment?)
  • What are the possible benefits and risks of participating? (what can participants gain from enrolling, are there any side effects of the treatments and if so, what are the symptoms?)
  • Where is the study run from? (what are the approximate number and names of centres taking part in this trial, if there is a lead centre, which one is it?)
  • When is study starting and how long is it expected to run for? (what is the anticipated start date and the approximate duration of the trial?)
  • How long will the trial be recruiting participants for? (who is funding the study, who will be paying the costs that the trial will incur during its lifecycle?)
  • Who is the main contact? (if this is the same as the contact in the record, please provide the name and email address only, if different to the contact in the record, please provide the name, position they hold at the institution/organisation and their email address)

We acknowledge that all those questions are already covered in the rest of the record apart from the potential benefits and risks, but please do not copy and paste information already in the record and do not paste in the abstract of an intended publication. Please instead give some thought to how you can present complex scientific information to non-experts and get the message across.

In order for the text to be written in very plain English (and not as an abstract for a peer-reviewed paper) ISRCTN recommends the use of the following guidance developed and used by CancerHelp UK.

  • Order logically, to maximise natural flow. Don’t go into more detail than you need.
  • Shorten your sentences. Take out unnecessary words and cut out repetition.
  • Substitute simpler words and phrases: 'before' rather than 'prior to', 'if' rather than 'in the event of', 'how well X works' rather than 'efficacy of X', 'treatment' rather than 'intervention', 'study' rather than 'randomised controlled trial', 'dummy' rather than 'placebo'.
  • Active, not passive: 'participants will have chemotherapy' rather than 'the chemotherapy will be given to participants'. Phrase positively, not negatively where possible: Participants will come to the hospital every third week rather than 'Participants will not need to come to the hospital for 2 weeks out of 3'.
  • Include medical terms after the plain English: 'Participants will have an operation to remove their prostate (a radical prostatectomy)'.
  • Include abbreviations after the full term: 'chronic lymphocytic leukaemia (CLL)'.
  • Use same tense throughout.

The following ISRCTN records contain examples of what we would expect plain English summaries to include:
ISRCTN24760606
ISRCTN03408765

Primary outcome measures (WHO)

The primary outcomes of a study are the data, or results, from which the main aims of the clinical trial can be assessed. It can be used to decide whether a hypothesis has been proven or principal question answered. For cancer drug trials, for example, a primary outcome might be how effective it has been at shrinking the size of a tumour. Please enter all primary outcome measures, the method used to measure each outcome, and the exact timepoints at which each outcome will be measured. Use a numbered list with a new line for each item. Please do not enter the actual results of these outcome measures in this field.

An example of an outcome measure might be: Pain after surgery, measured using the visual analogue score (VAS) at 24, 48 and 72 hours after surgery.

You should refer to the COMET (Core Outcome Measures in Effectiveness Trials) initiative which aims to develop "core outcome sets", that is, agreed outcome measures reported for all trials in a particular field and how these outcomes should be measured. See COMET for further information.

Primary study design (WHO)

Please select from the drop-down menu whether your study is observational or interventional.

Protocol /serial number (WHO)

This is for the internal reference given to the study by the researcher, the funder or sponsor etc. You can enter the study ID here if you have registered your study in any other register apart from EudraCT or ClinicalTrials.gov (see above). NIHR, HTA and Wellcome Trust grant numbers can be included here and also IRAS reference numbers. Please enter N/A if you do not have a Protocol/Serial number.

Publication and dissemination plan

Please briefly outline your plans for publication and dissemination of the trial results, including what you are intending to publish and when.

Publication summary

The purpose of this field is to list all publications resulting from the study. If you are registering prospectively it is likely that you will not have any resulting publications yet so please leave this field blank. If you are registering at a later stage, you may have publications pertaining to the study. Please do not include publications relating to other studies or trials or resulting from a literature search prior to this study.

Public title (WHO)

The public title is intended for the lay public in easily understood plain English. It should be brief but contain enough information so that a member of the lay public would easily understand the main aim of the study.

Purchase order number/reference numbers

If this application is funded by your institution, you may need a purchase order (PO) from the finance department before an invoice can be paid. Check with them and enter the reference our invoice should quote in this field.

Recruitment end date

The end date, or planned end date, of recruitment of participants for the trial.

Recruitment start date (WHO)

The date, or planned date, of recruitment of the first participant to the study. If your study is registered before or on the recruitment start date, it will be listed as 'prospectively registered'. If your study is registered after the recruitment start date, it will be listed as 'retrospectively registered'.

Results – basic reporting

From 2015 public registries are expected to include information about results. See WHO statement published in April 2015. Disclosure of results in a registry should not preclude publication in a peer-reviewed journal. Any information provided in a registry should be factual and not include any interpretation. This field is for basic results reporting in a scientific format. Guidelines to be developed.

Results – Plain English Summary

This field is for basic results reporting in plain English. Guidelines to be developed.

Scientific title (WHO)

The scientific title is intended for use in grant and ethics applications. It should be in the PICO format, containing information on the Participants in the trial, its Intervention(s) and the Comparisons and Outcomes of the trial. If you use an acronym for your study, use upper case letters for the corresponding letters.

Secondary outcome measures (WHO)

The secondary outcomes of a study are the data, or results, that answer questions relevant to the study but secondary to those assessed by the primary outcomes. For cancer drug trials, for example, a secondary outcome may be calculating whether a new drug shown to shrink tumours are also more cost effective than the current conventional treatment. Please enter all secondary outcome measures, the method used to measure each outcome, and the exact timepoints at which each outcome will be measured. Use a numbered list with a new line for each item. Please do not enter the actual results of these outcome measures in this field.

An example of an outcome measure might be: Pain after surgery, measured using the visual analogue score (VAS) at 24, 48 and 72 hours after surgery.

You should refer to the COMET (Core Outcome Measures in Effectiveness Trials) initiative which aims to develop "core outcome sets", that is, agreed outcome measures reported for all trials in a particular field and how these outcomes should be measured. See COMET for further information.

Secondary study design

If interventional, select from the following options:

  • Randomised controlled trial: A clinical trial with a intervention and control group, where allocation to a group is done randomly
  • Non-randomised study: A clinical trial with a intervention and control group, where allocation to a group is not done randomly, but by some other method
  • Randomised parallel trial: A type of randomised controlled trial where two interventions or treatments are compared. This could be, for example, two different drugs or different doses of the same drug
  • Randomised cross-over trial: A type of randomised controlled trial where, at some point during the study, the two arms of the trial swap over so that both groups undergo both interventions but in a different order
  • Cluster randomised trial: A type of randomised controlled trial where a group of people are all placed into either the intervention or control group of a trial. See example.
  • Other: Select if the study design for your trial is not listed above

If observational, select from the following options:

  • Case-control study: An observational study where a group of people with, for example, a disease (or some other variable of interest) is compared with a control group that doesn’t have the disease.
  • Nested case-control study: This is a variation of the case-control study where, for example, a group of people at risk of developing a disease is identified and the control group is then made up of participants from that group which have not developed the disease by the time the study begins. The intervention group is made up of the participants who do have the disease being studied
  • Longitudinal study: An observational study where a specific set of observations are taken over a long period of time
  • Cohort study: A type of longitudinal study where a specific set of observations are taken for a specific group of people (an cohort) over a long period of time
  • Case series: An observational study which follows a group of people with, for example, a particular condition and treated in a similar way, over a specified period of time
  • Epidemiological study: An observational study that compares two groups of people which are similar in every way other than for one variable, for example, two demographically similar populations living in similar conditions other than one population is exposed to a potentially damaging chemical
  • Ecological study: An observational study looking at the effect of risk-causing variables (for example, environmental factors) on health or other outcome measures in a specific population group
  • Cross-sectional study: An observational study where data is collected and analysed for a specified group of people at one specified point in time
  • Other: Select if the study design for your trial is not listed above

The sponsor is the organisation (rather than an individual) taking primary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting.

You can add another sponsor by clicking on "Add another sponsor".

Sponsor Privacy

Sponsors may request that the telephone number and email address are not displayed in the public trial record by selecting "Hide telephone and email details" option from the drop-down.

Study design (WHO)

Please briefly describe, in one sentence, the study design for your study, i.e. if observational or interventional. If observational, please also include details about the duration and type of study (e.g., cross-sectional cohort study, longitudinal case-control study). If interventional, please include details about allocation, masking, control and assignment. Please also specify whether the study is single-centre or multicentre.

Example: Single centre randomised single-blind placebo-controlled cross-over controlled study

Please do not include specific information on any interventions or observations here.

Study hypothesis (WHO)

The principal questions or hypotheses addressed by the study.

Hypotheses are best suited to interventional trials, and are statements that may be proved or disproved as a result of the study. For example, a hypothesis might be "Drug X is better than Drug Y". For observational trials, if no hypotheses are available, please enter a rationale for why the study is taking place.

You might find it useful to refer to the reporting guidelines appropriate for your study. SPIRIT provides guidelines to help improve the quality of interventional trial protocols. CONSORT provides guidelines for randomised controlled trials. STROBE provides guidelines for observational studies. Please also refer to EQUATOR for further information on reporting of research studies.

Trial Participating centre: Name

A trial may take place in many countries and have many participating centres/sites. Please list all the sites (provide at least the name and postcode) where the research is taking place. These should be the centres where the participants attend to take part in the trial rather than where the trial is administered from. You can indicate which one is the lead centre if applicable. If your study takes place in more than one country, you must include the details of at least one participating centre for each country listed, including the postal code. You can add another centre by clicking on "Add another centre".

Trial setting

Studies can be run from a variety of different settings. Select where the study will take place from the drop-down. Options are as follows:

  • Hospitals: Study takes place in a hospital. Examples may include experimental diagnostic or surgical procedures
  • GP practices: Study takes place at a local primary health care facility - for example, a NHS GP practice in the UK
  • Home: Study takes place in a home setting. Participants may collect the intervention from elsewhere and undertake the study at home or have a professional visit them at home to deliver the intervention
  • Internet: Study involves an intervention in the form of an internet-based website, software or email
  • Community: Study that take place within the participants' local community
  • Schools: Study takes place in an institution that teaches young people up to the age of 18
  • Other: Select other if in a setting not listed above
Trial type

A study can be classified by its purpose, that is, by the reason why it is taking place. Options are as follows:

  • Diagnostic: Trial that tests a new or improved diagnostic procedure
  • Prevention: Trial that aims to prevent one or more medical or other condition
  • Quality of life: Trial that aims to improve the quality of life for a target group of the population
  • Screening: Trial that aims to identify an undiagnosed disease or condition in people who have not shown any symptoms
  • Treatment: Trial that tests a new or improved treatment for a disease or condition
  • Other: Select other if trial is of a different type to those listed above
Trial website

If available, please give the URL of the trial website. This field should only contain websites developed specifically for the trial; the website of the sponsor organisation can be included in the sponsor section.

See example

VAT number

Getting a trial ID may be subject to VAT (value added tax or sales tax) depending on the applicant’s country. Enter the relevant VAT number in this field.

Why did you choose ISRCTN to register your trial?

Please tell us why you decided to register your study with the ISRCTN registry by selecting the most appropriate option from the drop-down. If selecting “Other (please specify)”, please give further information in the free text field that appears.

  • Previously registered a trial
  • The location of the trial
  • Publisher policy
  • Funding agency policy
  • Regulatory agency policy
  • Institution policy
  • Ethics committee policy
  • Regulatory body policy
  • Decision of principal investigator
  • Straightforward registration process
  • Expert scientific editing and curating
  • Other (please specify)