Table 2.

World Health Organization Trial Registration Data Set

	Item	Definition/Explanation
1.	Primary Register and Trial ID #	Name of trial register in which this trial was first registered (the trial’s “Primary Register”), and the unique ID number assigned by the Primary Register.
2.	Date of Registration in Primary Register	Date when trial was officially registered in the Primary Register YYYY/MM/DD.
3.	Secondary ID#s	Other identifying numbers and issuing authorities besides the Primary Register, if any. This includes the sponsor name and sponsor-issued trial number (e.g., protocol number) if available, and other trial registers that have issued an ID number to this trial.
4.	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	The individual, organisation, group, or other legal person taking on responsibility for securing the arrangements to initiate and/or manage a study (including arrangements to ensure that the design of the study meets appropriate standards and to ensure appropriate conduct and reporting). The primary sponsor is normally the main applicant for regulatory authorization to begin the study. It may or may not be the main funder.
6.	Secondary Sponsor(s)	Additional individuals, organisations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship.
7.	Contact for Public Queries	Email address, telephone number, or address of the contact who will respond to general queries, including information about current recruitment status
8.	Contact for Scientific Queries	Email address, telephone number, or postal address, and affiliation of the person to contact for scientific inquiries about the trial (e.g., principal investigator, medical director employed by the sponsor). For a multicenter study, the contact should be for the lead principal investigator or overall scientific director.
9.	Public Title	Title intended for the lay public in easily understood language.
10.	Scientific Title	Scientific title of the study as it appears in the protocol submitted for funding and ethical review, including the trial acronym if available.
11.	Countries of Recruitment	The countries from which participants will be, are intended to be, or have been recruited
12.	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)	The specific name of the intervention(s) and the comparator/control(s) being studied. The International Non-Proprietary Name should be used if possible (not brand/trade names). For an unregistered drug, the generic name, chemical name, or company serial number is acceptable. The control intervention(s) is/are the interventions against which the study intervention is evaluated (e.g., placebo, no treatment, active control). If an active control is used, the name(s) of that intervention, or “placebo” or “no treatment” should be provided as applicable. For each intervention, other intervention details should also be described as applicable (dose, duration, mode of administration, etc)
14.	Key Inclusion and Exclusion Criteria	Inclusion and exclusion criteria for participant selection, including age and sex.
15.	Study Type	A single arm study is one in which all participants are given the same intervention. Trials in which participants are assigned to receive 1 of 2 or more interventions are NOT single arm studies.Crossover trials are NOT single arm studies. A trial is “randomized” if participants are/were assigned to intervention groups using a method based on chance (e.g., random number table, random computer-generated sequence, minimization).
16.	Date of First Enrollment	Anticipated or actual date of enrollment of the first participant (YYYY/MM).
17.	Target Sample Size	Number of participants that this trial plans to or had planned to enroll
18.	Recruitment Status	Recruitment status of this trial (Pending, Active, Temporary halt, Closed)
19.	Primary Outcome(s)	Outcomes are events, variables, or experiences that trial investigators measure 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).
20.	Secondary Outcomes	Secondary outcomes are events, variables, or experiences of secondary interest or that are measured at timepoints of secondary interest. A secondary outcome may involve the same event, variable, or experience as the primary outcome, but measured at time points other than those of primary interest (e.g., primary outcome: all-cause mortality at 5 years; secondary outcome: all-cause mortality at 1 year, 3 years), or may involve a different event, variable, or experience altogether (e.g., primary outcome: all-cause mortality at 5 years; secondary outcome: hospitalization rate at 5 years).

Adapted from the WHO International Clinical Trials Registry Platform, http://www.who.int/ictrp/data_set/en/index1.html.