Example

​

"Australian New Zealand Clinical Trials Registry (ANZCTR)

ACTRN 12622000949785

Date registered: 05/07/2022.

…

www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12622000949785"[56].

​​​

Explanation

 

There are compelling ethical and scientific reasons for trial registration [57-62].

​

Documentation of a trial’s existence and pre-specified outcomes in a publicly accessible registry helps to increase transparency, decrease unnecessary duplication of research effort, facilitate identification of ongoing trials for prospective participants, and identify and deter selective reporting of study results [63, 64]. A trial registration number can serve to “link together” all of the documents related to a trial, starting with the protocol [65]. As mandated by the International Committee of Medical Journal Editors (ICMJE) and jurisdictional legislation [31, 32, 66] registration of clinical trials should occur before recruitment of the first trial participant. 

 

The protocol should state the name of the registry and the assigned registration number. If the trial is not yet registered, the intended registry should be named, and the registration details updated prior to participant enrolment. When registration in multiple registries is required (e.g., to meet regulations), each identifier should be listed in the protocol and each registry. Online protocol authoring tools such as the SPIRIT Electronic Protocol Tool and Resource (SEPTRE) enable automated transfer of relevant information to trial registries (e.g., ClinicalTrials.gov) [67].

 

Particular attention should be given to registering complete descriptions of protocol-specified outcomes (Item 16), as prior reviews have reported frequent discrepancies in the primary outcomes defined in registries as compared with those specified in protocols of randomised trials [64]. 

​

Summary of key elements to address

• Name of registry

• Trial registry identifying number

• URL to registry record

• Date of registration