Descrição
CONTENTS:
Scope
Normative references
Terms and definitions
Ethical considerations
Improper influence or inducement
Compensation and additional health care
Responsibilities
Communication with the ethics committee (EC)
Initial EC submission
Information to be obtained from the EC
Continuing communication with the EC
Continuing information to be obtained from the EC
Vulnerable populations
Informed consent
Process of obtaining informed consent
Special circumstances for informed consent
Information to be provided to the subject
Informed consent signature
New information
Clinical investigation planning
Risk evaluation
Justification for the design of the clinical investigation
Clinical investigation plan (CIP)
Investigators brochure (IB)
Case report forms (CRFs)
Monitoring plan
Investigation site selection
Agreement(s)
Labelling
Data monitoring committee (DMC)
Clinical investigation conduct
Investigation site initiation
Investigation site monitoring
Adverse events and device deficiencies
Clinical investigation documents and documentation
Amendments
Subject identification log
Source documents
Additional members of the investigation site team
Subject privacy and confidentiality of data
Document and data control
Traceability of documents and data
Recording of data
Electronic clinical data systems
Investigational device accountability
Accounting for subjects
Auditing
Suspension, termination and close-out of the clinical investigation
Suspension or premature termination of the clinical investigation
Procedure for suspension or premature termination
Procedure for resuming the clinical investigation after temporary suspension
Routine close-out
Clinical investigation report
Document retention
Responsibilities of the sponsor
Clinical quality assurance and quality control
Clinical investigation planning and conduct
Selection of clinical personnel
Preparation of documents and materials
Conduct of clinical investigation
Monitoring
Safety evaluation and reporting
Clinical investigation close-out
Outsourcing of duties and functions
Communication with regulatory authorities
Responsibilities of the principal investigator
Qualification of the principal investigator
Qualification of investigation site
Communication with the EC
Informed consent process
Compliance with the CIP
Medical care of subjects
Safety reporting
Clinical investigation plan (CIP)
Investigators brochure (IB)
Case report forms (CRFs)
Clinical investigation report
Essential clinical investigation documents
Adverse event categorization
Bibliography
