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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