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 Organization (WHO) as one of the 24 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 use the update request form or email us at firstname.lastname@example.org quoting your study ID, and we will do this for you on your behalf.
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 an 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.
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 study hypothesis field.
Cardiovascular disease and co-morbid type 2 diabetes
If possible, you should supply a professional, or work-based, email address rather than a personal email address. If you are a study contact, your email address will be displayed publicly.
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 you do not and you are interested in obtaining one, you can go to the ORCID website for further information.
In circumstances where there may be a risk of undue harassment if an individual’s name or contact information is publicly disclosed, the telephone number and email address can be recorded within the registry for use by the registry but not made publicly available. Assessment of the potential risk should be on a case-by-case basis at the discretion of the registry.
Contact type (WHO)
The contact for public queries is the person who will respond to general queries, including information about the current recruitment status. There must be clearly assigned responsibility for scientific leadership to a named Principal Investigator (also known as Chief Investigator in the UK). The PI may delegate responsibility for dealing with scientific enquiries to a scientific contact for the trial. This scientific contact will be listed in addition to the PI. You can add multiple contacts by clicking on "Add another contact".
The information provided in here is functional and not personal, it is recommended to provide institutional and not personal information. By providing this information the registrant consents that the information provided can or may be published on a public website.
Countries of recruitment (WHO)
Please select all the locations 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 Clinical Research Network Portfolio database. Please click here for further information.
Many studies involve the administration of a drug, biological, vaccine or device. Please enter the name(s) of all drugs, biologicals, vaccines or devices being administered in the study, including active controls. Where possible, include the INN or other generic name of drugs and biologicals in order to aid searching.You must complete this field if you have described your intervention type as a drug, biological/vaccine or device.
Ethics approval (WHO)
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 review committee (providing an English translation of the name if appropriate), the contact details of the ethics committee (mailing address, telephone number and email address), 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 which ethics review committee you plan to submit to. If your study does not require ethics approval, please tell us why. See example.
EudraCT/Clinical Trials Information System (CTIS) number (WHO)
If your trial is also registered in the European Clinical Trial (EudraCT) database or CTIS and you have a unique EudraCT/CTIS number, enter it here. The format is YYYY-123456-78 for EudraCT and EU-CT 2022-50xxxx-xx-xx for CTIS. Otherwise please write ‘Nil known’
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 Crossref Funder Registry (formerly 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 multiple funders by clicking on "Add another funder".
Individual participant data (IPD) sharing statement (WHO)
Participant level data refers to the individual participant data (IPD), also known as ‘raw data’, collected during your study. In compliance with the June 2017 ICMJE statement, your data-sharing intentions are expected to be stated at study registration as well as at manuscript submission. As a result, could you please confirm which of the following statements would be appropriate in your case, providing as many of the details in italics as possible. You can choose more than one option if applicable. Storing in a publicly available repository is the gold standard and if you provide a link to your dataset now or add one later your study will receive a green raw data badge.
- The datasets generated during and/or analysed during the current study will be stored in a publicly available repository (please provide the repository name/weblink, the type of data that will be shared, when the data will become available and for how long, by what access criteria the data will be shared including with whom, for what types of analyses, and by what mechanism, whether consent from participants was obtained, comments on data anonymisation, any ethical or legal restrictions, any other comments)
- The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository (please provide the repository name/weblink, the type of data that will be shared, when the data will become available and for how long, by what access criteria the data will be shared including with whom, for what types of analyses, and by what mechanism, whether consent from participants was obtained, comments on data anonymisation, any ethical or legal restrictions, any other comments)
- The datasets generated during and/or analysed during the current study are/will be available upon request from (please provide the name and email address, the type of data that will be shared, when the data will become available and for how long, by what access criteria data will be shared including with whom, for what types of analyses, and by what mechanism, whether consent from participants was obtained, comments on data anonymisation, any ethical or legal restrictions, any other comments)
- The datasets generated and/or analysed during the current study will be published as a supplement to the results publication
- The datasets generated during and/or analysed during the current study are not expected to be made available due to (please provide the reason)
- The data-sharing plans for the current study are unknown and will be made available at a later date (you will be requested to add a data-sharing statement at a later date)
If your plans change you will be able to update your data-sharing statement at a later date.
IPD sharing summary (WHO)
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 BMC’s policy). The purpose of this field is to summarise your plans regarding the availability of participant-level data (sometimes referred to as raw data). Please select the most appropriate option(s) from the box on the left.
- Stored in publicly available repository
- Stored in non-publicly available repository
- Available on request
- Published as a supplement to the results publication
- Not expected to be made available
- Data sharing statement to be made available at a later date
Intention to publish date
Please give an estimated date of publication of the results of your study.
The intervention refers to the treatment or action tested or observed 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 studies, please provide a brief summary of your methodology, providing details of any tests to be run, observations made and other relevant information.
Please select the intervention type from the drop-down that most accurately describes that used in your trial. Options are as follows:
- Drug: A chemical substance used as a medicine and recognised in an official pharmacopeia. Examples would include antibiotics and drugs used in chemotherapy
- 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
- Device: This includes instruments, apparatus, machines or implants, for example, surgical lasers, hearing aids and MRI equipment
- Biological/Vaccine: Biological products used as medicines. This includes vaccines, blood and blood products, and human cells and tissues used for transplantation
- Procedure/Surgery: Invasive or external procedures/therapies or external therapies used in medical treatment
- Behavioural: Treatment that is designed to modify a person’s behaviour. This includes behavioural therapies, group therapies and relaxation techniques
- Genetic: This includes gene therapies and identification of genes or polymorphisms involved in disease
- Mixed: Please select this option if multiple types of intervention are used
- Other: Please select if the intervention is different to any listed above
Overall trial end date (WHO)
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 ethics approval date and the recruitment start date. Please give the overall 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
- Other: Please select if the 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: Sex (WHO)
Please select the sex 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: People who have the disease or condition that is being studied
- Health professional: People who work in the healthcare sector. This includes, for example, medical doctors, dentists and nurses
- Carer: People 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 send a file to the ISRCTN editor processing your submission, who can then upload the file once the trial is registered. 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".
After your study registration has been submitted, it will be processed by our in-house editorial team to ensure that all the required information is present and consistent. Once the record is complete and ready for publication, you will be required to pay a one-off fee of GBP226 + tax when applicable (GBP250 + tax from 01 July 2022) for the study to be registered with an ISRCTN and published online. This fee helps to cover the cost of editing and curation, ongoing maintenance, and permanent online hosting.
Please select the method of payment for the 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 authorisation of payment. A receipt will be emailed to you within 10 days after the payment has been made.
- Offline payment: Please select if you wish to pay by credit/debit card, bank transfer or cheque on receipt of an invoice. 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 GBP20.
- 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 (e.g. NIHR, HTA or Wellcome Trust).
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 0: These involve a very small number of people, usually fewer than 15. Investigators use a very small dose of medication to make sure it isn’t harmful to humans before they start using it in higher doses for later phases.
- Phase I: These involve only small numbers of people, often healthy volunteers, and they are used to find out the safe dose range for the drug and test for side effects
- Phase I/II: These studies test the drug's general safety and appropriate dosage levels in people with the targeted condition, often where it would be unethical to expose healthy volunteers to a drug expected to have side effects, such as a cancer chemotherapy drug
- Phase II: These involve people with the targeted condition and the aim is to get an idea of safety in patients and effective dose levels
- 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 on a smaller scale than in phase III
- Phase III: This is the stage when a large scale, randomised clinical trial takes place, where the drug being tested is compared with 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 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 non-expert 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 in the public view of a registered study record. We ask that you present the information using the following headings:
- Background and study aims (brief description of the disease or area of study and what is the objective/aim of the study)
- Who can participate? (what is 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 measurements will be taken)
- 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? (which institution is managing the study?)
- When is the study starting and how long is it expected to run for? (what are the overall start and end dates?)
- 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 some of the information required is already covered in the rest of the record apart from the background and study aims and 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 Cancer Research 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 the same tense throughout.
The following ISRCTN records contain examples of what we would expect plain English summaries to include:
Primary outcome measure (WHO)
The primary outcome measure of a study is the data, or results, from which the main aim 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 measure might be the size of a tumour or level of a biomarker. Please enter the primary outcome measure, the method used to measure it, and the timepoints at which the outcome will be measured or the duration over which the outcome measure will be monitored. Please do not enter the actual results of the outcome measure in this field.
An example of an outcome measure might be: Pain after surgery, measured using a 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 field is for any internal reference numbers 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 should be included here and also IRAS Project IDs. Please enter N/A if you do not have a protocol/serial number. Please do not enter the version number of the protocol here.
Publication and dissemination plan
Please briefly outline your plans for publication and dissemination of the trial results, including what you intend to publish, where and when.
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 you intend to pay the registration fee on receipt of an invoice (offline payment), you may need a purchase order (PO) from the finance department of your institution before an invoice can be paid. Check with them and enter the reference our invoice should quote in this field.
Recruitment end date
The actual or expected date of recruitment of the last participant.
Recruitment start date (WHO)
The actual or expected 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'. The study is registered once the registration fee payment has been received.
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, Intervention(s), 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 outcome measures of a study are the data, or results, that answer questions relevant to the study but secondary to those assessed by the primary outcome. For cancer drug trials, for example, a secondary outcome measure might be the incidence of a certain adverse event. Please enter all secondary outcome measures, the method used to measure each outcome measure, and the exact timepoints at which each outcome measure will be measured or the duration over which the outcome measure will be monitored. 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 your study is 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 (note that case reports, meta analyses, systematic reviews, animal studies, and studies with no outcomes measured in humans are not accepted)
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 who 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 (a cohort) over a long period of time
- Case series: An observational study that 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 (note that case reports, meta analyses, systematic reviews, animal studies, and studies with no outcomes measured in humans are not accepted)
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. The sponsor telephone number and email address should not be the same as those of the study contact.
You can add multiple sponsors by clicking on 'Add another sponsor'.
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 study
Please do not include specific information on any interventions or observations here.
Study hypothesis (WHO)
This field is for 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 lowers blood pressure significantly more 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.
Studies can be run from a variety of different settings. Select the setting(s) where the study will take place from the options available. Options are as follows:
- Built environment/local authority
- Care home
- Charity/Voluntary sector
- Dental clinic
- Fitness/sport facility
- GP practice
- Medical and other records
- Other therapist office
- Pharmaceutical testing facility
- Retail/food outlet
- Telephone or other remote access
- Training facility/simulation
- University/medical school/dental school
Total final enrolment
If your study has finished recruiting, please enter the total final enrolment number. This should include all participants actually enrolled in the study, regardless of any attrition subsequent to enrolment.
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, city, country and zip/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. 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 postcode. Please add all participating centres by clicking on 'Add another centre'.
A study can be classified by its purpose, that is, by the reason why it is taking place. Options are as follows:
- Diagnostic: Study that tests a new or improved diagnostic procedure
- Prevention: Study that aims to prevent one or more medical or other conditions
- Quality of life: Study that aims to measure or improve the quality of life for a target group of the population
- Screening: Study that aims to identify an undiagnosed disease or condition in people who have not shown any symptoms
- Treatment: Study that tests a new or improved treatment for a disease or condition
- Other: Select other if the study is of a different type to those listed above
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.
Getting a trial ID may be subject to a local tax (for example, value-added tax or sales tax) depending on the applicant's country. Enter the relevant local tax 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)