ISRCTN Required Data Items and WHO ICTRP Fields #
ID Section Field Name Compulsory Matching WHO ICTRP
fields #
1 APPLICANT Applicant title Yes Not Applicable
2 APPLICANT Applicant forename Yes Not Applicable
3 APPLICANT Applicant surname Yes Not Applicable
4 APPLICANT Applicant address Yes Not Applicable
5 APPLICANT Applicant town Yes Not Applicable
6 APPLICANT Applicant country Yes Not Applicable
7 APPLICANT Applicant zip Yes Not Applicable
8 APPLICANT Applicant tel No Not Applicable
9 APPLICANT Applicant fax No Not Applicable
10 APPLICANT Applicant email Yes Not Applicable
11 APPLICANT Where did you hear about the ISRCTN scheme? No Not Applicable
12 CONTACT Contact (LPI) title Yes 7 & 8
13 CONTACT Contact forename Yes 7 & 8
14 CONTACT Contact surname Yes 7 & 8
15 CONTACT Contact address Yes 7 & 8
16 CONTACT Contact city Yes 7 & 8
17 CONTACT Contact country Yes 7 & 8
18 CONTACT Contact zip Yes 7 & 8
19 CONTACT Contact tel No 7 & 8
20 CONTACT Contact fax No 7 & 8
21 CONTACT Contact email Yes 7 & 8
22 CONTACT Contact privacy Yes 7 & 8
23 SPONSOR Sponsor name Yes 5 & 6
24 SPONSOR Sponsor address Yes 5 & 6
25 SPONSOR Sponsor town Yes 5 & 6
26 SPONSOR Sponsor country Yes 5 & 6
27 SPONSOR Sponsor zip Yes 5 & 6
28 SPONSOR Sponsor tel No 5 & 6
29 SPONSOR Sponsor fax No 5 & 6
30 SPONSOR Sponsor email Yes 5 & 6
31 SPONSOR Sponsor website No 5 & 6
32 SPONSOR Sponsor privacy Yes 5 & 6
33 TRIAL ClinicalTrials.gov identifier if there is one No 3
34 TRIAL EudraCT number if there is one No 3
35 TRIAL Protocol/serial number Yes 3
36 TRIAL Public title Yes 9
37 TRIAL Scientific title No 10
38 TRIAL Acronym Yes 10
39 TRIAL Disease/condition/study domain Yes 12
40 TRIAL Study hypothesis Yes 15
41 TRIAL Lay summary Yes Not Required
42 TRIAL Ethics approval Yes Not Required
43 TRIAL Study design Yes 15
44 TRIAL Countries of recruitment Yes 11
45 TRIAL Participants - inclusion criteria Yes 14
46 TRIAL Participants - exclusion criteria Yes 14
47 TRIAL Patient information material No Not Required
48 TRIAL Anticipated start date Yes 16
49 TRIAL Anticipated end date Yes 16
50 TRIAL Target number of participants Yes 17
51 TRIAL Status Yes 18
52 TRIAL Interventions Yes 13
53 TRIAL Primary outcome measures(s) Yes 19
54 TRIAL Secondary outcome measures(s) Yes 20
55 TRIAL Trial website No Not Required
56 TRIAL Publications No Not Required
57 TRIAL Sources of funding (& refs) Yes 4
58 TRIAL ISRCTN Generated 1
59 TRIAL DOI Generated Not Applicable
60 TRIAL Date applied Generated Not Applicable
61 TRIAL Date ISRCTN assigned Generated 2
Apply at: http://www.controlled-trials.com/isrctn/submission/

Updated on 18 December 2012