Regulatory Compliance in Clinical Research Informatics
( 25 Modules )

Module #1
Introduction to Regulatory Compliance in Clinical Research Informatics
Overview of the importance of regulatory compliance in clinical research informatics, key regulations and guidelines

Module #2
Good Clinical Practice (GCP) and Good Informatics Practice (GIP)
Principles and guidelines for GCP and GIP, including ethics, informed consent, and data integrity

Module #3
FDA Regulations and Guidance
Overview of FDA regulations and guidance on electronic records and signatures, computer systems validation, and clinical trials

Module #4
ICH Guidelines and Standards
International Conference on Harmonisation (ICH) guidelines and standards for clinical trials, including E6, E8, and E9

Module #5
EU Regulations and Directives
Overview of EU regulations and directives on clinical trials, including GDPR and MDR

Module #6
HIPAA and Data Privacy
HIPAA regulations and guidance on protecting patient data, including security and breach notification rules

Module #7
Risk Management and Quality Assurance
Importance of risk management and quality assurance in clinical research informatics, including risk assessment and mitigation strategies

Module #8
Computer System Validation
Principles and best practices for computer system validation, including software development, testing, and deployment

Module #9
Electronic Records and Signatures
Regulatory requirements and best practices for electronic records and signatures, including Part 11 compliance

Module #10
Clinical Trial Management Systems (CTMS)
Overview of CTMS, including system selection, implementation, and validation

Module #11
Electronic Data Capture (EDC) Systems
Overview of EDC systems, including system selection, implementation, and validation

Module #12
Regulatory Submissions and Reporting
Regulatory requirements and best practices for submitting clinical trial data and reports to regulatory agencies

Module #13
Audits and Inspections
Preparation for and response to audits and inspections, including FDA and EU regulatory authority expectations

Module #14
Compliance in Clinical Research Informatics Projects
Importance of compliance in clinical research informatics projects, including project planning, execution, and monitoring

Module #15
Change Control and Configuration Management
Best practices for change control and configuration management in clinical research informatics systems

Module #16
Training and Competency
Importance of training and competency in clinical research informatics, including training programs and documentation

Module #17
Vendor Management and Outsourcing
Regulatory requirements and best practices for vendor management and outsourcing in clinical research informatics

Module #18
Data Security and Encryption
Best practices for data security and encryption in clinical research informatics, including cloud computing and data storage

Module #19
Compliance in Emerging Technologies
Regulatory considerations for emerging technologies in clinical research informatics, including AI, blockchain, and IoT

Module #20
Global Regulatory Compliance
Overview of regulatory requirements and compliance strategies for clinical trials conducted in multiple regions

Module #21
Compliance in Academic Research
Regulatory requirements and compliance considerations specific to academic research institutions

Module #22
Compliance in Sponsor-Site Interactions
Regulatory requirements and compliance considerations for sponsor-site interactions in clinical trials

Module #23
Regulatory Compliance in Data Analytics
Regulatory considerations for data analytics in clinical research informatics, including data mining and artificial intelligence

Module #24
Enforcement and Liability
Regulatory enforcement and liability in clinical research informatics, including FDA warning letters and lawsuits

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Compliance in Clinical Research Informatics career

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Regulatory Compliance in Clinical Research Informatics ( 25 Modules )

Regulatory Compliance in Clinical Research Informatics
( 25 Modules )