Table 1 Minimum data set that should be recorded for clinical trial registration, according to the International Standards launched by the World Health Organization, in 2006 (items felt to be commercially sensitive are highlighted)
From: Do trialists endorse clinical trial registration? Survey of a Pubmed sample
Number | Item | Abbreviated Definition/Explanation* |
|---|---|---|
1. | Primary register trial number | Name of Primary Register, and the unique ID number assigned by the Primary Register to this trial. |
2. | Trial registration date | Date when trial was officially registered in the Primary Register. |
3. | Secondary IDs | Other identifying numbers and issuing authorities besides the Primary Register, if any |
4. | Source(s) of monetary or material support | Major source(s) of monetary or material support for the trial |
5. | Primary sponsor | The individual, organization, group or other legal entity which takes responsibility for initiating, managing and/or financing a study. |
6. | 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. | 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. | 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. | Public title (of the study) | 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 |
11. | Countries of recruitment | The countries from which participants will be, are intended to be, or have been recruited. |
12. | Health condition or problems studied | Primary health condition(s) or problem(s) studied |
13. | Intervention(s) | Specific name of the intervention(s) and the comparator/control(s) being studied |
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 one of two or more interventions are NOT single arm studies. Crossover trials are NOT single arm studies. |
A trial is "randomized" if participants are assigned to intervention groups using a method based on chance (e.g., random number table, random computer-generated sequence, minimization, adaptive randomization). | ||
16. | Date of the first enrollment (anticipated or actual date of the enrollment of the first study participant) | If the trial is being registered after recruitment of the first participant record actual date of Anticipated date of enrollment of the first participant. |
17. | Target sample size | Number of participants that this trial plans to enroll. |
18. | Recruitment status | Recruitment status of the trial. |
19. | 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). |
20. | Key secondary outcomes | Secondary outcomes are events, variables, or experiences that are of secondary interest or that are measured at timepoints of secondary interest. |