1. Study Subject
1.1. participant in a clinical Trial
1.1.1. can be part of the control group
1.2. Enrolled after written consent
1.2.1. Can withdraw Consent at any time
1.3. Must be at least 18 years old
1.3.1. except study in minors
1.4. never pregnant woman
1.5. depend of study type and phase
1.5.1. proband (healthy)
1.5.2. patient (sick)
2. Clinical Data Manager
2.1. clinical data
2.1.1. storage
2.1.2. collection
2.1.3. analysis
2.2. check compliance with regulatory standard
2.3. Tasks
2.3.1. Developing & implementing data management plan
2.3.2. transfer final data to biostatician
2.3.3. **eCRF** electronic Case Report Form
2.3.3.1. creating
2.3.3.2. maintaining
2.3.3.3. plausibility check integration
3. Study Nurse
3.1. acting as the main contact person for ..
3.1.1. Study Subject
3.1.1.1. patient
3.1.1.2. proband
3.1.2. clinical monitor
3.1.3. investigators
3.2. Coordinating necessary tasks throughout the clinical trial
3.2.1. preparing the study site for the trial
3.3. Administering and managing
3.3.1. Study documents
3.3.2. binders
3.4. Assisting with medical examinations of participants
3.4.1. patient care
3.5. source data
3.5.1. documenting
3.5.2. collecting
3.6. Managing laboratory logistic
3.7. patient visit
3.7.1. planning
3.7.2. preparing
4. Investigator
4.1. Physician who is part of the Study at a study site
4.1.1. expertise
4.1.2. experience in patient care
4.1.3. scientific expertise
4.2. Types
4.2.1. Principal Investigator
4.2.2. Sub-Investigator
4.2.3. Coordinating-Investigator
4.2.3.1. Medical overview
5. Sponsor
5.1. Responsibilities
5.1.1. Tasks
5.1.1.1. Ensure quality assurance
5.1.1.2. Obtain ethical reviews and approvals by authorities
5.1.1.3. provide nessessary information to each party at any time
5.1.1.4. select
5.1.1.4.1. investigators
5.1.1.4.2. study site
5.1.1.5. Ensure compliance with all laws, regulations and Guidlines
5.1.2. clinical trial
5.1.2.1. financing
5.1.2.2. initiation
5.1.2.3. managing
5.2. Who
5.2.1. individual
5.2.2. company
5.2.3. institution
6. Clinical Research Associate (CRA)
6.1. Clinical Monitor
6.1.1. Responsibilities
6.1.1.1. Checking compliance of study execution with …
6.1.1.1.1. the clinical Trial protocol
6.1.1.1.2. ICH-GCP & ISO14155
6.1.1.2. Source data verification during one site visits
6.2. role
6.2.1. Comminication with trial sites
6.2.2. reviewing collected data
6.2.3. ensuring Good clinical practise (GCP)
6.2.4. Reporting
6.2.4.1. discrepancies