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What data will be shared with ISRCTN Registry?

Last updated on 31 Jan 2022

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 trails of an investigational medicinal product and a medical device (IMP/device).

The table below sets out what data will be sent to ISRCTN Registry and the corresponding IRAS questions and WHO required fields. 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 Lay summary of the study ISRCTN may suggest edits to the applicant
13 Trial website ISRCTN to collect from applicant if applicable
14 Contact type Selected by ISRCTN from a pull-down menu
15 Primary contact (name) Study information: C5 Point of contact for publication Contact for public queries/contact for scientific queries Yes
16 ORCHID ID ISRCTN to collect from applicant if applicable
17 Contact details (address and email) Study information: C5 Point of contact for publication Contact for public queries/contact for scientific queries Yes
18 Contact type n/a n/a Selected by ISRCTN from a pull-down menu
19 Additional contact (name) Medicines information question set: G-1 National coordinating investigator (for a multicentre trial) or principle investigator (for a single centre trial) Contact for public queries/contact for scientific queries
20 ORCHID 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) Contact for public queries/contact for scientific queries
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 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: E6 Scope of the 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 informaiton sheet ISRCTN to collect from applicant
36 Condition Medicines information question set: E 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
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 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 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 abondoned (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 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 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 number of enrollment ISRCTN to collect from applicant
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' Date of first enrollment Yes
54 Recruitment end date ISRCTN to collect from applicant 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 Organisation B1 Sponsor Primary sponsor/secondary sponsor Yes
58 Sponsor details B1 Sponsor Primary sponsor/secondary sponsor Yes
59 Sponsor type B1 Sponsor Primary sponsor/secondary sponsor
60 Website ISRCTN to collect from applicant Primary sponsor/secondary sponsor
61 GRID Generated by ISRCTN
62 Funder type Project informaiton: FQ03.01 Project funder Selected by ISRCTN from a pull-down menu
63 Funder name Project informaiton: FQ03.01 Project funder Source(s) of monetary or material support
64 Funder alternative name(s) Generated by ISRCTN
65 Funding Body Type Generated by ISRCTN
66 Funding Body Sub-type Generated by ISRCTN
67 Location Generated by ISRCTN
68 Publication and dissemination plan Study informatin: C-1 How do you intend to report and disseminate the results of the study? Yes
69 Intention to publish date ISRCTN to contact applicant
70 Individual participant data (IPD) sharing statement Study information: C-2 How will you enable sharing of study data with others? IPD sharing statement
71 Participant level data Generated by ISRCTN based on IPD sharing statement
72 Trial outputs ISRCTN to collect from applicant Summary results
73 Additional files Materials supplied by applicant, to be uploaded by ISRCTN
74 Editorial files Publicly visible notes where changes are logged
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