This journal requires registration of randomized clinical trials in such public trial registries as those of the National Institutes of Health and the International Standard Randomized Controlled Trials. The International Committee of Medical Journal Editors (ICJME) has established a requirement that all clinical trials be entered in a public registry before the onset of patient enrollment, as a condition of consideration for publication. The definition of a clinical trial as established by the ICMJE is any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relation between a medical intervention and a health outcome. ClinicalTrials.gov or similar registries provide a vehicle which allows organizations and individuals to provide the data requested by ICMJE, which has adopted the World Health Organization (WHO) minimal registration data set. Clinical trials should have a NCT registration code or IRCT code or other similar codes (see below) which can be Starting on July 2010. The journal will be including the identifier number in Clinical Trial articles. This rule is concluded from the International Committee of Medical Journal Editors (ICMJE) Web site for their editorial and updates on the topic of registering clinical trials before publication of the results. The ICMJE recommends that the clinical trial registration number be included at the end of the abstract. A sample of general display format for the code obtained from ClinicalTrials.gov is: an alphabetic label of ClinicalTrials.gov followed by a slash and then an 11-digit alphanumeric string starting with NCT followed by eight numbers. For instance, an example in the Citation format display would be: ClinicalTrials.gov/NCT00000161.

 

Which trials registries are acceptable to tthis journal?
Phase III trials must be registered, and phase II trials are appropriate to register. Most phase I trials do not need to be registered. Please clearly state in the methods section of the manuscript the trial registration number including where the registration is publicly available. Visit the for more information. This Journal accepts registration in the following registries:

1. www.irct.ir
2. www.actr.org.au
3. www.clinicaltrials.gov
4. www.ISRCTN.org
5. www.umin.ac.jp/ctr/index/htm
6. www.trialregister.nl

 

More information and update can be found at: http://www.icmje.org/faq_clinical.html and Primary Registries in the WHO Registry Network