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Table 1 WHO minimal dataset: version issued in April 2005 (used as checklist in this study) [5] and revised version issued in February-March 2006[9]

From: Compliance of clinical trial registries with the World Health Organization minimum data set: a survey

  Item 2005 Revised Item 2006 Abridged Definition/Explanation*
1 Unique trial number Primary Registry and Trial Identification number Name of Primary Registry, and the unique ID number assigned by the Primary Registry to this trial.
2 Trial registration date Date of Registration in Primary Registry Date when trial was officially registered in the Primary Registry.
3 Secondary IDs Secondary identification number(s) Other identifying numbers and issuing authorities besides the Primary Registry, if any.
4 Funding source(s) Source(s) of Monetary or Material Support Major source(s) of monetary or material support for the trial (e.g., funding agency, foundation, company).
5 Primary sponsor Primary Sponsor The individual, organization, group or other legal person taking responsibility for securing the arrangements to initiate and/or manage a trial (including arrangements to ensure that the trial design meets appropriate standards and to ensure appropriate conduct and reporting).
6 Secondary sponsor(s) 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.
7 Responsible contact person Contact for Public Queries Email address, telephone number, or postal address of the contact who will respond to general queries, including information about current recruitment status
8 Research contact person Contact for Scientific Queries Email address, telephone number, or postal address, and affiliation of the person to contact for scientific queries about the trial.
9 Title of the study (brief title) Public Title Title intended for the lay public in easily understood language.
10 Official scientific title of the study Scientific Title Scientific title of the trial as it appears in the protocol submitted for funding and ethical review. Include trial acronym if available.
11 Research ethics review   Eliminated
   Countries of Recruitment The countries from which participants will be, are intended to be, or have been recruited.
12 Condition Health Condition(s) or Problem(s) Studied Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer, medication error).
13 Intervention(s) Intervention(s) Enter the specific name of the intervention(s) and the comparator/control(s) being studied. Use the International Non-Proprietary Name if possible. If the intervention consists of several separate treatments, list them all. For each intervention, describe other intervention details as applicable (dose, duration, mode of administration, etc).
14 Key inclusion and exclusion criteria Key Inclusion and exclusion criteria Inclusion and exclusion criteria for participant selection, including age and sex.
15 Study type Study Type A single arm trial is one in which all participants are given the same intervention. A trial is "randomized" if participants are assigned to intervention groups using a method based on chance.
16 Anticipated trial start date Date of First Enrollment Anticipated or actual date of enrollment of the first participant.
17 Target sample size Target Sample Size Number of participants that this trial plans to enroll.
18 Recruitment status Recruitment Status Recruitment status of this trial (e.g., pending, active, temporary halt, closed).
19 Primary outcome Primary Outcome(s) Outcomes are events, variables, or experiences that are measured because it is believed that they may be influenced by the intervention. The Primary Outcome should be the outcome used in sample size calculations, or the main outcome(s) used to determine the effects of the intervention(s). Enter the names of all primary outcomes in the trial as well as the pre-specified timepoint(s) of primary interest.
20 Key secondary outcomes Key Secondary Outcomes Secondary outcomes are events, variables, or experiences that are of secondary interest or that are measured at timepoints of secondary interest.
  1. * From the final version released in February 2006