| 0 |
E-061 |
4.a |
AnalysisUnit |
Collection unit |
Collection unit |
enumerated |
Describes the entity being analysed in the study or variable. |
nan |
Individual |
1 |
1 |
| 1 |
E-062 |
4.b |
ResearchType |
Study type |
Study Type |
enumerated |
Indicates the type of the research, including interventional (also known as experimental) studies and observational studies. |
nan |
Observational Study;Interventional Study |
1 |
1 |
| 2 |
E-153 |
4.1.a |
IsClinicalTrial |
Declaration of a clinical trial |
Is this a clinical trial? |
boolean |
Indicates if the study is a clinical trial. |
If E-062 = "Interventional study" |
nan |
1 |
1 |
| 3 |
E-064 |
4.1.b |
TrialPhase |
Study Phase |
Study Phase |
array |
The stage of a clinical trial defining the objectives and methods of evaluating a drug or biological product (tolerance, efficacy, comparison, follow-up). |
If E-062 = "Interventional study" AND if E-153="True" |
Phase 1;Phase 2;Phase 3;Phase 4;NA |
1 |
Inf. |
|
|
|
|
|
ST : For combined phases, check several options. |
|
|
|
|
|
|
| 4 |
E-063 |
4.1.c |
ResearchPurpose |
Primary research purpose |
Primary research purpose |
array |
The main objective of the intervention(s) being evaluated by the study. |
If E-062 = "Interventional study" |
Treatment;Health Services Research;Prevention;Basic Science;Diagnostic;Device Feasability;Supportive Care;Screening;Other |
1 |
Inf. |
| 5 |
E-178 |
4.1.d |
OtherResearchPurpose |
Other research purpose, details |
Other research purpose, details |
string |
Indicates other research purpose not listed in the provided options. |
If E-062 = "Interventional study" AND if E-063="Other" |
nan |
0 |
1 |
| 6 |
E-065 |
4.1.e |
InterventionalStudyModel |
Intervention model |
Intervention model |
enumerated |
General design of the strategy for assigning interventions to participants in a study. |
If E-062 = "Interventional study" |
Single Group;Parallel;Crossover;Factorial;Sequential |
1 |
1 |
| 7 |
E-066 |
4.1.2.a |
AllocationMode |
Allocation type |
Allocation type |
enumerated |
Method used to assign participants to different intervention groups or arms in an clinical study. |
If E-062 = "Interventional study" |
Randomised;Nonrandomised |
1 |
1 |
| 8 |
E-067 |
4.1.2.b |
AllocationUnit |
Allocation unit |
Allocation unit |
enumerated |
Entity to which the intervention is assigned. |
If E-062 = "Interventional study" |
Individuelle;Cluster |
1 |
1 |
| 9 |
E-068 |
4.1.3.a |
MaskingType |
Masking type |
Masking type |
enumerated |
Indicates whether the study is conducted open-label (all parties know the assigned intervention) or with masking (at least one party is unaware of the assigned intervention). |
If E-062 = "Interventional study" |
Blinded;Open label |
1 |
1 |
| 10 |
E-069 |
4.1.3.b |
BlindedMaskingDetails |
Blinded masking group(s) |
Blinded masking group(s) |
array |
Specifies which stakeholders in the study (participant, care provider, investigator, outcome assessor ) are unaware of the assigned intervention, in order to reduce bias. |
If E-062 = "Interventional study" |
Participant;Care provider;Research Team Member;Outcomes Assessor |
1 |
Inf. |
| 11 |
E-071 |
4.1.4.a |
ArmName |
Arm name |
Arm name |
string |
Unique title chosen for the arm. |
If E-062 = "Interventional study" |
nan |
1 |
1 |
| 12 |
E-072 |
4.1.4.b |
ArmType |
Arm type |
Arm type |
enumerated |
A general description of the study arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, sham comparator arm, and no intervention arm. |
If E-062 = "Interventional study" |
Experimental;Active Comparator;Placebo Comparator;Sham Comparator;No intervention;Other |
1 |
1 |
| 13 |
E-073 |
4.1.4.c |
ArmTypeOther |
Other arm type, details |
Other arm type, details |
string |
Indicates any other arm type not listed in the provided options. |
If E-062 = "Interventional study" AND if E-072 = "Other" |
nan |
0 |
1 |
| 14 |
E-074 |
4.1.4.d |
ArmDescription |
Arm description |
Arm description |
string |
Brief description of the arm, including its purpose or characteristics. |
If E-062 = "Interventional study" |
nan |
0 |
1 |
| 15 |
E-075 |
4.2.a |
ObservationalStudyDesign |
Observational study design |
Observational study design |
enumerated |
Describes the methodological approach of the observational study, specifying how participants are selected and monitored or observed. |
If E-062 = "Observational study" |
Cohort study;Case-control study;Practices registry;Morbidity registry;Case study;Case-crossover study;Other |
1 |
1 |
| 16 |
E-076 |
4.2.b |
OtherResearchTypeDetails |
Other study design, details |
Other study design, details |
string |
Indicates any other study design not listed in the provided options. |
If E-062 = "Observational study" AND if E-075 = "Other" |
nan |
1 |
1 |
| 17 |
E-154 |
4.2.c |
TimePerspective |
Time perspective |
Time perspective |
enumerated |
Indicates the temporal dimension of data collection in the observational study. |
If E-062 = "Observational study" |
Retrospective longitudinal;Prospective longitudinal;One-time cross-sectional study;Repeated cross-sectional study;Other |
0 |
1 |
| 18 |
E-199 |
4.2.d |
IsInclusionGroups |
Declaration of inclusion groups |
Does the study include several groups defined at enrollment ? |
boolean |
Indicates if the study include several groups defined at the time of inclusion. |
nan |
nan |
nan |
nan |
|
|
|
|
|
ST : If yes, complete the following fields |
|
|
|
|
|
|
| 19 |
E-079 |
4.2.1.a |
GroupName |
Group name |
Group name |
string |
Unique title chosen for the inclusion group. |
nan |
nan |
1 |
1 |
| 20 |
E-080 |
4.2.1.b |
GroupDescription |
Group description |
Group description |
string |
Description of the characteristics of each group at inclusion, specifying the criteria used to distinguish them (e.g. type of exposure, clinical, socio-demographic or contextual characteristics). |
nan |
nan |
0 |
1 |
| 21 |
E-082 |
4.2.2.a |
InterventionName |
Factor/exposure name |
Factor/exposure name |
string |
The specific name of the action, factor or exposure as it is referred to in the study. Factors include various health products or non-invasive approaches, such as education or changes to diet and exercise. Exposures may include, for example, lifestyle habits, environmental factors, or medical history. |
nan |
nan |
1 |
1 |
| 22 |
E-083 |
4.2.2.b |
InterventionType |
Factor/exposure type |
Factor/exposure type |
enumerated |
Selection of the category that best describes the factor or the exposure from the predefined list of options. |
nan |
Drug;Device;Biological-Vaccine;Procedure-Surgery;Radiation;Behavioral;Genetic;Dietary Supplement;Diagnostic Test;Combination Product;Public Health;Other |
0 |
1 |
| 23 |
E-084 |
4.2.2.c |
InterventionTypeOther |
Other factor/exposure type, details |
Other factor/exposure type, details |
string |
Indicates any other factor or exposure type not listed in the provided options. |
If E-083="Other" |
nan |
0 |
1 |
| 24 |
E-115 |
4.3.a |
PrimaryOutcomes |
Primary Outcome |
Primary Outcome |
string |
The main pre-specified measurement or observation of the study, used to address the primary research question. |
nan |
nan |
1 |
1 |
| 25 |
E-116 |
4.3.b |
SecondaryOutcomes |
Secondary Outcome(s) |
Secondary Outcome(s) |
string |
Additional pre-specified measurements or observations that provide complementary information or explore related aspects of the primary question. |
nan |
nan |
0 |
1 |