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 1
34 TRIAL Protocol/serial number Yes 3
35 TRIAL Public title Yes 9
36 TRIAL Scientific title No 10
37 TRIAL Acronym Yes 3
38 TRIAL Disease/condition/study domain Yes 12
39 TRIAL Study hypothesis Yes 15
40 TRIAL Ethics approval Yes Not Required
41 TRIAL Study design Yes 15
42 TRIAL Countries of recruitment Yes 11
43 TRIAL Participants - inclusion criteria Yes 14
44 TRIAL Participants - exclusion criteria Yes 14
45 TRIAL Patient information material No Not Required
46 TRIAL Anticipated start date Yes 16
47 TRIAL Anticipated end date Yes 16
48 TRIAL Target number of participants Yes 17
49 TRIAL Status Yes 18
50 TRIAL Interventions Yes 13
51 TRIAL Primary outcome measures(s) Yes 19
52 TRIAL Secondary outcome measures(s) Yes 20
53 TRIAL Trial website No Not Required
54 TRIAL Publications No Not Required
55 TRIAL Sources of funding (& refs) Yes 4
56 TRIAL ISRCTN Generated 1
57 TRIAL Date applied Generated Not Applicable
58 TRIAL Date ISRCTN assigned Generated 2
Apply at: http://www.controlled-trials.com/isrctn/submission/

Updated in December 2007