From January 2022 we are automatically registering clinical trials with ISRCTN Registry as one of the steps to ensure research transparency. This has started with trials submitted through combined review in the new part of IRAS. Studies being registered automatically are clinical trials of investigational medicinal products (CTIMPs) and combined trials of an investigational medicinal product and a medical device (IMP/device).
The table below lists the data displayed in an ISRCTN registration record, which data is required by the WHO and how the data is collected (ie whether it is sent to ISRCTN from IRAS or whether ISRCTN collects it separately). The final column shows the limited information that will be published if a trial has an agreement to defer registration in place.
| Row number | ISRCTN Field | IRAS question number | IRAS question | Comments | WHO required field | Information published if a deferral is in place? |
| 1 | ISRCTN number | Generated by ISRCTN | Primary registry and trial identifying number | Yes | ||
| 2 | DOI | Generated by ISRCTN | ||||
| 3 | Public title | Medicines information question set: A3-1 | Title of the trial for lay people, in easily understood, i.e. non-technical, language | Public title | ||
| 4 | Condition category | Selected by ISRCTN from a pull-down menu | ||||
| 5 | Date applied | Generated by ISRCTN at submission | ||||
| 6 | Date assigned | Generated by ISRCTN at registration | Date of registration in primary registry | |||
| 7 | Last edited | Generated by ISRCTN | ||||
| 8 | Prospective/retrospective | Generated by ISRCTN using rows 6 and 53 | ||||
| 9 | Overall trial status | Generated by ISRCTN using rows 43 and 44 | ||||
| 10 | Recruitment status | Generated by ISRCTN using rows 53 and 54 | Recruitment status | |||
| 11 | Publication status | Generated by ISRCTN based on submission to 72 | ||||
| 12 | Plain English Summary | Study Information: A9, B4 | Lay summary of the study. What are the potential risks and burdens for research participants and how will you minimise them? | ISRCTN may suggest edits to the applicant and will ask for potential benefits of participating | ||
| 13 | Trial website | ISRCTN to collect from applicant if applicable | ||||
| 14 | Contact type | Selected by ISRCTN from a pull-down menu | ||||
| 15 | Primary contacts (This can be scientific contact or public contact or principal investigator) | Study information: C1 or C2 | Point of contact for publication | Contact can be for public queries/contact for scientific queries/principal investigator. This is agreed during our communications. | This can be the contact for public queries/contact for scientific queries/principal investigator | Yes |
| 16 | ORCID ID | ISRCTN to collect from applicant if applicable | ||||
| 17 | Contact details (address and email) | Study information: C1 | Point of contact for publication | This can be the contact for public queries/contact for scientific queries/principal investigator | Yes | |
| 18 | Contact type | n/a | n/a | Selected by ISRCTN from a pull-down menu | ||
| 19 | Additional contact (name) (This can be scientific contact or public contact or principal investigator) | Medicines information question set: G-1 | National coordinating investigator (for a multicentre trial) or principal investigator (for a single centre trial) | This can be the contact for public queries/contact for scientific queries/principal investigator | ||
| 20 | ORCID ID | ISRCTN to collect from applicant if applicable | ||||
| 21 | Additional contact details (address and email) | Medicines information question set: G-1 | National coordinating investigator (for a multicentre trial) or principal investigator (for a single centre trial) | This can be the contact for public queries/contact for scientific queries/principal investigator | ||
| 22 | IRAS number | Supplied by HRA | Secondary identifying number | Yes | ||
| 23 | EudraCT number | Medicines information question set: A2 | European Clinical Trials Database (EudraCT) number | Secondary identifying number | Yes (if available) | |
| 24 | ClinicalTrials.gov number | Medicines information question set: A5-2 | Clinicaltrials.gov | Secondary identifying number | ||
| 25 | Protocol/serial number | Medicines information question set: A4-1 | Sponsor's protocol code number | Secondary identifying number | ||
| 26 | Scientific title | Medicines information question set: A3 | Full title of the trial | Scientific title | ||
| 27 | Acronym | Medicines information question set: A3-2 | Name or abbreviated title of the trial where available | |||
| 28 | Study hypothesis | Medicines information question set: E2-1 and E2-2 | Main objective of the trial and Secondary objectives of the trial | |||
| 29 | Ethical approval | Supplied by HRA | Ethics review | Yes | ||
| 30 | Study design | Medicines information question set: E8 | Design of trial | Study type | Yes (limited information only) | |
| 31 | Primary study design | N/A | N/A | Selected by ISRCTN from a pull-down menu - default to 'Interventional' for CTIMPs | Study type | |
| 32 | Secondary study design | Medicines information question set: E8 | Design of the trial | Selected by ISRCTN from a pull-down menu, eg "Randomised controlled trial" | Study type | |
| 33 | Trial setting | Selected by ISRCTN from a pull-down menu: Hospitals, GP Practices, Other, Home, Internet, Community, Schools | ||||
| 34 | Trial type | Medicines information question set: E6 | Scope of the trial | Selected by ISRCTN from a pull-down menu: Diagnostic, Other, Prevention, Quality of life, Screening, Treatment | Yes | |
| 35 | Patient information sheet | ISRCTN to collect from applicant (optional) | ||||
| 36 | Condition | Medicines information question set: E1 | Medical condition or disease under investigation | Health condition(s) or problem(s) studied | ||
| 37 | Intervention | ISRCTN to collect from applicant | Intervention(s) | |||
| 38 | Intervention type | Medicines information question set: D3-11 section | Type of IMP | Selected by ISRCTN from a pull-down menu. The relevant options for CTIMPs are: Biological/vaccine, Device, Drug, Mixed, Other | ||
| 39 | Phase | Medicines information question set: E-7 section | Trial type and phase | Study type | ||
| 40 | Drug names | Medicines information question set: D2-1-1-1, D3-1, D3-2, D3-8 | Trade name, product name where applicable, product code where applicable, name of active substance (INN or proposed INN if available) | Intervention(s) | ||
| 41 | Primary outcome measures | Medicines information question set: E5-1, E5-1-1 | Primary end point(s), Timepoint(s) of evaluation of this end point | ISRCTN will ask for the method of measurement of the outcome variable if this is not already provided | Primary outcomes | |
| 42 | Secondary outcome measures | Medicines information question set: E5-2, E5-2-1 | Secondary end point(s), Timepoint(s) of evaluation of this end point | ISRCTN will ask for the method of measurement of the outcome variable if this is not already provided | Key secondary outcomes | |
| 43 | Overall trial start date | N/A | N/A | Date of submission to IRAS to be used | ||
| 44 | Overall trial end date | FQ04.10 | Proposed Study End Date | Completion date | Yes | |
| 45 | Reason abandoned (if stopped) | ISRCTN to collect from applicant if applicable | ||||
| 46 | Participant inclusion criteria | Medicines information questions set: E3 | Please list the principal inclusion criteria | Key inclusion and exclusion criteria | ||
| 47 | Participant type | Medicines information question set: F3 | Group of trial subjects | Selected by ISRCTN from pulldown menu: All, Carer, Health professional, Healthy volunteer, Mixed, Not specified, Other, Patient | Key inclusion and exclusion criteria | |
| 48 | Age group | Medicines information question set: F1 | Age Range | Selected by ISRCTN from a pull-down menu: Neonate, Child, Adult, Senior, All, Mixed, Other | Key inclusion and exclusion criteria | |
| 49 | Gender | Medicines information question set: F2 | Gender | Selected by ISRCTN from pulldown menu: Both, Female, Male, Not specified | Key inclusion and exclusion criteria | |
| 50 | Target number of participants | Medicines information question set: F4-2-2 | Planned number of subjects to be included - in the whole clinical trial | Sample size | ||
| 51 | Total final enrolment | ISRCTN to collect after trial has completed recruitment (eg when results are posted) | Sample size | |||
| 52 | Participant exclusion criteria | Medicines information question set: E4 | Please list the principal exclusion criteria | Key inclusion and exclusion criteria | ||
| 53 | Recruitment start date | Medicines information question set: E8-10-1 or E8-10-2 | Proposed date of start of recruitment 'In the Member State concerned' or 'In any country', whichever is earlier | Recruitment status | Yes | |
| 54 | Recruitment end date | ISRCTN to collect from applicant | Recruitment status | Yes | ||
| 55 | Countries of recruitment | E-8-6-3 | Specify the countries in which trial sites are planned | Countries of recruitment | ||
| 56 | Trial participating centre | ISRCTN to collect from applicant | ||||
| 57 | Sponsor organisation | B5 | Sponsor | Primary sponsor/secondary sponsor | Yes | |
| 58 | Sponsor contact details | B5 | Sponsor | Yes | ||
| 59 | Sponsor type | B5 | Selected by ISRCTN from pulldown menu: Charity, Government, Hospital/treatment centre, Industry, Other, Research council, Research organisation, University/education | |||
| 60 | Trial website | ISRCTN to collect from applicant | ||||
| 61 | GRID | https://www.grid.ac/ entity selected by ISRCTN | ||||
| 62 | Funder type | Project information: FQ03.01 | Project funder | Selected by ISRCTN from a pull-down menu: Charity, Government, Hospital/treatment centre, Industry, Other, Research council, Research organisation, University/education | ||
| 63 | Funder name | Project information: FQ03.01 | Project funder | Source(s) of monetary or material support | ||
| 64 | Funder alternative name(s) | Automatically added to the record by Crossref's Funder Registry (https://www.crossref.org/services/funder-registry/) | ||||
| 65 | Funding Body Type | Automatically added to the record by Crossref's Funder Registry (https://www.crossref.org/services/funder-registry/) | ||||
| 66 | Funding Body Sub-type | Automatically added to the record by Crossref's Funder Registry (https://www.crossref.org/services/funder-registry/) | ||||
| 67 | Location | Automatically added to the record by Crossref's Funder Registry (https://www.crossref.org/services/funder-registry/) | ||||
| 68 | Publication and dissemination plan | Study information: C-1 | How do you intend to report and disseminate the results of the study? | Yes | ||
| 69 | Intention to publish date | ISRCTN will set this date to 1 year after the overall trial end date (completion date), but this date can be changed on request. It is used to provide a guidance date when users can expect results to be available and also for ISRCTN to send a prompt 6 months after the date if results have not yet been posted to the registry record. | ||||
| 70 | Individual participant data (IPD) sharing statement | ISRCTN to contact applicant | Data sharing plan | |||
| 71 | IPD sharing summary | Generated by ISRCTN based on IPD sharing statement | ||||
| 72 | Trial outputs | ISRCTN to collect from applicant before and after registration as appropriate | Summary results | |||
| 73 | Additional files | Participant information sheet linked from trial outputs | ||||
| 74 | Editorial notes | Publicly visible notes where changes are logged | Audit trail |