Randomized controlled trials (RCTs) sometimes require additional items for publication. Most commonly these are as follows:
- Trial registration numbers at a WHO accredited trial registry
- A CONSORT-eHEALTH checklist
- A CONSORT flow diagram of study participants
The below table details exactly which item is required for each type of manuscript, or the stage of research:
|Type of Randomized Controlled Trial|
|Does my RCT need...||Protocol/Proposal||Pilot Study or Formative Study||Results Paper||Secondary Analysis|
|a peer-review report?||Yes (if funded) to get a 50% discount||No||No||No|
|prospective trial registration?||Not required, but can be included||Highly recommended, but not required*||Yes*||Highly recommended, but not required*|
|a CONSORT-EHEALTH checklist?||No||Yes||Yes||Not required, but best practice would be to include it|
*If an exception is made for retrospective registration OR lack of prospective registration, an Editorial Notice is required and will be added by your layout editor during typesetting.
Other helpful links:
CONSORT-EHEALTH for Randomized Controlled Trials
Does my trial (RCT) have to be registered?
How do I cite my trial registration?
We are doing a substudy of a RCT - do we still need to report according to CONSORT-EHEALTH?
How do I get a 20% discount on the Article Processing Fee if my protocol was previously published in JMIR Research Protocols?