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Access to all Academy Services
Modules including:
- e-learnings
- assignments
- knowledge checks
Industry recognized Professional Certification
- Get Cognitio Certificate
- GCP Certification
5 Steps Guide to Get Your Dream Job
- Set clear goals
- Get properly trained
- CV, CV, CV
- Ace Your Interview
- Negotiate
Global Clinical Research Jobs
- Weekly new Global Jobs
- Skip the Application Line
- Join Career Events
Introduction to Clinical Research
- Historical events that shaped today’s research platform.
- Nuremberg Code (1947)
- Declaration of Helsinki (1964)
- Belmont Report Principles (1979)
- National Research Act (1974)
- International Standard Organization 14155
ICH/GCP and CFR 21
- A global response to unethical research
- International Council of Harmonisation and Good Clinical Practice Guidelines (ICH/GCP)
- 14 principles of GCP
- Food and Drug Administration (FDA)
Clinical Research Process and Study Design
- Clinical Research Process
- Study Designs in Clinical Trials
- Randomization
- Non-Randomization
- Phases of clinical research
- Pre-Clinical
- Phases I-IV
Clinical Research Organizations, Vendors, Ethic Boards and Sites
- Understand Clinical Research organizational char
- Clinical Site Organizations
- Site Management Organizations
- Vendors
- Sites
- Pharmaceuticals/Biopharma
- Institutional Review Board/IEC
Study Coordinator and Site Staff
- Investigators
- Supplemental research staff
- Documentation requirements for assigned task
- CRCs responsibility for managing site staff training and delegation log
- Delegation Log
Protocol and Informed Consent Form (ICF)
- Clinical Research Protocol
- Informed Consent Form (ICF)
- Source Documents
- Medical Records
- Standard of Operations
Medical History, Adverse Events/Serious Adverse Events and Concomitant Medication
- Adverse Events
- Serious Adverse Events
- Concomitant Medication (ConMed)
- Medical History-out
The Monitor
- Monitor Role
- Visits
- Selection
- Initiation
- Interim
- Close Out
- Booster
- Communication
- Query Resolution
- Identifying and resolving site issues
Our Expert Instructors
Vince W
CRA Instructor
Cynthia L
CRA Instructor
Jessie C
CRA Instructor
Lauren M
CRA Instructor
Other Clinical Research Courses
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