Study with healthy volunteers
Conditions
Interventions
Group 1: Part 1: Retrospective data analysis of screening tests from previous studies
Group 2: Part 2: Prospective data collection through interviews and questionnaires.
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Part 1: - Screening examination as a healthy volunteer within an approved Phase 0 or Phase I clinical trial conducted under the German Medicinal Products Act (AMG) between 2012 and 2022. Part 2: - Ability to understand the study information and willingness to provide written informed consent for voluntary study participation. - Current or = 24-month prior participation in a clinical trial involving healthy volunteers conducted under the German Medicinal Products Act (AMG).
Exclusion criteria
Exclusion criteria: Part 1: None. Part 2: Inability to communicate with the study physician or to understand the study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: - Screening success rate - Identification of reasons for screen failure - Classification of screen failure reasons and evaluation by frequency Part 2: Identification of key topics in the screening process using semi-structured interviews, followed by the development of a questionnaire. Descriptive analysis of the questionnaire, particularly insights regarding: - Participants' expectations regarding the informed consent discussion - Decision-making processes and motivations for participation in the study - Participants’ risk perception of studies in general and study-related procedures - Quality of the informed consent discussion | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: - Comparison of screening success rates and reasons for screen failure across studies Part 2: - Analysis of subgroups, correlations, and influencing factors based on sociodemographic data and other responses from the data collection. | — |
Countries
Germany
Contacts
Public ContactAntje Blank
Universitätsklinikum Heidelberg
Outcome results
None listed