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?