metaRegister of Controlled Trials: Essential Data Items for Prospective Registration of Controlled Trials (October 2002)

IDENTIFICATION

• Source of record (name of organisation supplying record).
• Trial sponsor (if different from above).
• International Standard Randomised Controlled Trial Number (ISRCTN)*.
• Serial number/protocol number (used by organisation/sponsor supplying the record).
• Reference numbers from other organisations (i.e. list any other registers where the trial is listed, including reference number if known). Current Controlled Trials (CCT) can advise on suitable format.

TRIAL DETAILS

• Title of trial/grant title.
• Acronym (if available).
• Disease or condition.
• Current status of trial: please choose one



• Planned (i.e. not yet recruiting participants).
• Open (i.e. actively recruiting new participants).
• Closed to recruitment of participants: follow-up continuing.
• Closed to recruitment of participants: follow-up complete.
• Terminated (reason).
• Other (reason).



• Patient information material: please provide URL for access to patient information material, or attach in electronic file when submitting trial register. CCT can advise.
• Topic/hypothesis/clinical objectives.
• Design/methodology. Note: all should be randomised controlled trials.
• Trial participant eligibility - inclusion criteria.
• Trial participant eligibility - exclusion criteria.
• Randomised interventions (please describe all interventions and trial arms, including dosages and duration for each, starting a new line for each one).

FUNDING

• Sources of funding (please list all known sources, and serial numbers if possible). CCT can advise on format.

CONTACT

• Lead Principal Investigator (the individual with legal and scientific responsibility for the trial).
  Name, full address, telephone, (fax) and email. Note: registers may request that telephone, fax and email are not displayed in their records, but are asked to provide these if at all possible.

* The International Standard Randomised Controlled Trial Number is a simple numeric system for the identification of randomised controlled trials worldwide. It will simplify the identification of trials and provide a unique number that can be used to track all publications and reports resulting from each trial. Contact us for further information about the ISRCTN scheme.