Changes between Version 17 and Version 18 of TrialRegistrationDataSetPtBr
- Timestamp:
- 02/23/10 12:44:13 (3 years ago)
Legend:
- Unmodified
- Added
- Removed
- Modified
-
TrialRegistrationDataSetPtBr
v17 v18 29 29 ... 30 30 31 1. Primary Registry and Trial Identifying Number32 33 Name of Primary Registry, and the unique ID number assigned by the Primary Registry to this trial. (see: [PrimaryIdNumberField PrimaryIdNumber]) 31 [1. Primary Registry and Trial Identifying Number 32 33 Name of Primary Registry, and the unique ID number assigned by the Primary Registry to this trial. (see: [PrimaryIdNumberField PrimaryIdNumber]) ] 34 34 35 35 === 2. Data de Registro no Rebrac === … … 39 39 ... 40 40 41 2. Date of Registration in Primary Registry42 43 Date when trial was officially registered in the Primary Registry. (see: [RegistrationDateField RegistrationDate]) 41 [2. Date of Registration in Primary Registry 42 43 Date when trial was officially registered in the Primary Registry. (see: [RegistrationDateField RegistrationDate]) ] 44 44 45 45 === 3. Identificadores secundários do ensaio === … … 56 56 ... 57 57 58 3. Secondary Identifying Numbers59 60 Other identifying numbers and issuing authorities besides the Primary Registry, if any. Include the sponsor name and sponsor-issued trial number (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided. (see: [SecondaryIdNumbersField SecondaryIdNumbers]) 58 [3. Secondary Identifying Numbers 59 60 Other identifying numbers and issuing authorities besides the Primary Registry, if any. Include the sponsor name and sponsor-issued trial number (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided. (see: [SecondaryIdNumbersField SecondaryIdNumbers]) ] 61 61 62 62 === 4. Fonte(s) de apoio financeiro ou material === … … 66 66 ... 67 67 68 4. Source(s) of Monetary or Material Support68 [4. Source(s) of Monetary or Material Support 69 69 70 70 Major source(s) of monetary or material support for the trial (e.g., funding agency, foundation, company). (see: [SupportSourcesField SupportSources]) … … 76 76 ... 77 77 78 5. Primary Sponsor78 [5. Primary Sponsor 79 79 80 80 The individual, organization, group or other legal entity which takes responsibility for initiating, managing and/or financing a study. The Primary Sponsor is responsible for ensuring that the trial is properly registered. The Primary Sponsor may or may not be the main funder. (see: [PrimarySponsorField PrimarySponsor]) … … 93 93 ... 94 94 95 6. Secondary Sponsor(s)95 [6. Secondary Sponsor(s) 96 96 97 97 Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. A secondary sponsor may have agreed: … … 112 112 ... 113 113 114 7. Contact for Public Queries114 [7. Contact for Public Queries 115 115 116 116 Email address, telephone number, or postal address of the contact who will respond to general queries, including information about current recruitment status. (see [PublicContactField PublicContact]) … … 124 124 ... 125 125 126 8. Contact for Scientific Queries126 [8. Contact for Scientific Queries 127 127 128 128 Email address, telephone number, or postal address, and affiliation of the person to contact for scientific queries about the trial (e.g., principal investigator, medical director employed by the sponsor). For a multi-center study, enter the contact information for the lead Principal Investigator or overall scientific director. (see [ScientificContactField ScientificContact]) … … 136 136 ... 137 137 138 9. Public Title138 [9. Public Title 139 139 140 140 Title intended for the lay public in easily understood language. (see [PublicTitleField PublicTitle]) … … 148 148 ... 149 149 150 10. Scientific Title150 [10. Scientific Title 151 151 152 152 Scientific title of the study as it appears in the protocol submitted for funding and ethical review. Include trial acronym if available. (see [ScientificTitleField ScientificTitle]) … … 160 160 ... 161 161 162 11. Countries of Recruitment162 [11. Countries of Recruitment 163 163 164 164 The countries from which participants will be, are intended to be, or have been recruited. (see [RecruitmentCountriesField RecruitmentCountries]) … … 174 174 ... 175 175 176 12. Health Condition(s) or Problem(s) Studied176 [12. Health Condition(s) or Problem(s) Studied 177 177 178 178 Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer, medication error). If the study is conducted in healthy human volunteers belonging to the target population of the intervention (e.g. preventive or screening interventions), enter the particular health condition(s) or problem(s) being prevented. If the study is conducted in healthy human volunteers not belonging to the target population (e.g., a preliminary safety study), an appropriate keyword will be defined for users to select. (see [HealthConditionsField HealthConditions]) … … 188 188 ... 189 189 190 13. Intervention(s)190 [13. Intervention(s) 191 191 192 192 Enter the specific name of the intervention(s) and the comparator/control(s) being studied. Use the International Non-Proprietary Name if possible (not brand/trade names). For an unregistered drug, the generic name, chemical name, or company serial number is acceptable. If the intervention consists of several separate treatments, list them all in one line separated by commas (e.g., "low-fat diet, exercise"). … … 202 202 ... 203 203 204 14. Key Inclusion and Exclusion Criteria204 [14. Key Inclusion and Exclusion Criteria 205 205 206 206 nclusion and exclusion criteria for participant selection, including age and sex. (see [InclusionCriteriaField InclusionCriteria]) … … 216 216 ... 217 217 218 15. Study Type218 [15. Study Type 219 219 220 220 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. … … 234 234 ... 235 235 236 16. Date of First Enrollment236 [16. Date of First Enrollment 237 237 238 238 Anticipated or actual date of enrollment of the first participant. (see [FirstEnrollmentDateField FirstEnrollmentDate]). … … 244 244 ... 245 245 246 17. Target Sample Size246 [17. Target Sample Size 247 247 248 248 Number of participants that this trial plans to enroll. (see [SampleSizeField SampleSize]) … … 261 261 ... 262 262 263 18. Recruitment Status263 [18. Recruitment Status 264 264 265 265 Recruitment status of this trial: … … 269 269 * Complete: participants are no longer being recruited or enrolled 270 270 * Other 271 272 (see [RecruitmentStatusField RecruitmentStatus]) 271 ] 273 272 274 273 === 19. Desfecho(s) primário(s) === … … 284 283 ... 285 284 286 19. Primary Outcome(s)285 [19. Primary Outcome(s) 287 286 288 287 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). … … 290 289 Enter the names of all primary outcomes in the trial as well as the pre-specified timepoint(s) of primary interest. Be as specific as possible with the metric used (e.g., “% with Beck Depression Score > 10” rather than just “depression”). 291 290 292 Examples: Outcome Name: all-cause mortality, Timepoints: 5 years; or Outcome Name: Mean Beck Depression Score, Timepoint: 18 weeks 293 294 (see [PrimaryOutcomesField PrimaryOutcomes]) 291 Examples: Outcome Name: all-cause mortality, Timepoints: 5 years; or Outcome Name: Mean Beck Depression Score, Timepoint: 18 weeks ] 295 292 296 293 === 20. Desfecho Secundários === … … 306 303 ... 307 304 308 20. Key Secondary Outcomes305 [20. Key Secondary Outcomes 309 306 310 307 Secondary outcomes are events, variables, or experiences that are 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 timepoints 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). … … 312 309 Enter the name and timepoint(s) for all secondary outcomes of clinical and/or scientific importance. Be as specific as possible with the metric used (e.g., “% with Beck Depression Score > 10” rather than just “depression”). 313 310 314 Examples: Outcome Name: all-cause mortality, Timepoint: 6 months, 1 year; or Outcome Name: Mean glycosylated hemoglobin A1C, Timepoint: 4 and 8 weeks 315 316 (see [SecondaryOutcomesField SecondaryOutcomes]) 311 Examples: Outcome Name: all-cause mortality, Timepoint: 6 months, 1 year; or Outcome Name: Mean glycosylated hemoglobin A1C, Timepoint: 4 and 8 weeks ]
