Item 2a: Trial identifier and registry name. If not yet registered, name of intended registry.
Example
“EudraCT: 2010-019180-10
ClinicalTrials.gov: NCT01066572
ISRCTN: 54540667.” 21
Explanation
There are compelling ethical and scientific reasons for trial registration.22-24 Documentation of a trial’s existence on a publicly accessible registry can help to increase transparency,24;25 decrease unnecessary duplication of research effort, facilitate identification of ongoing trials for prospective participants, and identify selective reporting of study results.26-28 As mandated by the International Committee of Medical Journal Editors (ICMJE) and jurisdictional legislation,29-31 registration of clinical trials should occur before recruitment of the first trial participant.
We recommend that registry names and trial identifiers assigned by the registries be prominently placed in the protocol, such as on the cover page. If the trial is not yet registered, the intended registry should be indicated and the protocol updated upon registration. When registration in multiple registries is required (e.g., to meet local regulation), each identifier should be clearly listed in the protocol and each registry.
| 1: Title | 2b: Trial registration – Data set |
