Field NameDefinition of the Data Element
Primary RegistryName of Primary Registry
Primary Registry IDUnique ID number assigned by the Primary Registry to this trial
Date of Registration in Primary RegistryDate when trial was officially registered in the Primary Registry.
Secondary Identifying Numbers
  • The Universal Trial Number
  • Identifiers assigned by the sponsor
  • Other trial registration numbers issued by other Registries
  • Identifiers issued by funding bodies, collaborative research groups, regulatory authorities, ethics committees / institutional review boards, etc.
Source(s) of Monetary or Material SupportMajor source(s) of monetary or material support for the trial (e.g. funding agency, foundation, company, institution)
Primary SponsorThe individual, organization, group or other legal entity which takes responsibility for initiating, managing and/or financing a study.
Secondary Sponsor(s)Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship.
Contact for Public QueriesEmail address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status.
Contact for Scientific QueriesThe PI may delegate responsibility for dealing with scientific enquiries to a scientific contact for the trial. This scientific contact will be listed in addition to the PI.
Public TitleTitle intended for the lay public in easily understood language.
Scientific TitleScientific title of the study as it appears in the protocol submitted for funding and ethical review.
Countries of RecruitmentThe countries from which participants will be, are intended to be, or have been recruited at the time of registration.
Health Condition(s) or Problem(s) StudiedPrimary health condition(s) or problem(s) studied (e.g., depression, breast cancer, medication error).
Intervention(s)For each arm of the trial record a brief intervention name plus an intervention description. For drugs: generic name, or temporary identifier for drugs that do not yet have a generic name; for other types of interventions: a brief descriptive name.
Key Inclusion and Exclusion CriteriaInclusion and exclusion criteria for participant selection, including age and sex.
Study TypeStudy type consists of:
  • Type of study (interventional or observational)
  • Study design including:
    • Method of allocation (randomized/non-randomized)
    • Masking (is masking used and, if so, who is masked)
    • Assignment (single arm, parallel, crossover or factorial)
    • Purpose
  • Phase (if applicable)
Date of First EnrollmentAnticipated or actual date of enrolment of the first participant.
Target Sample SizeNumber of participants that this trial plans to enroll in total
Recruitment StatusRecruitment status of this trial:
  • Pending: participants are not yet being recruited or enrolled at any site
  • Recruiting: participants are currently being recruited and enrolled
  • Suspended: there is a temporary halt in recruitment and enrolment
  • Complete: participants are no longer being recruited or enrolled
  • Other
Primary Outcome(s)For each primary outcome the name of the outcome, the metric or method of measurement used, and the timepoint(s) of primary interest.
Key Secondary OutcomesSecondary outcomes with the same description as primary outcomes (above).

From: Finding Grey Literature Evidence and Assessing for Outcome and Analysis Reporting Biases When Comparing Medical Interventions: AHRQ and the Effective Health Care Program

Cover of Methods Guide for Effectiveness and Comparative Effectiveness Reviews
Methods Guide for Effectiveness and Comparative Effectiveness Reviews [Internet].

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