1572 investigator state Study guides, Class notes & Summaries
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CITI GCP Training 2023/24 updated&verified
- Exam (elaborations) • 17 pages • 2023
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CH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must: 
Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records. 
 
ICH (2016) E6 Section 4.8.10(n) states that the informed consent should indicate that "the monitor(s), the auditor(s), the IRB/IEC, ...
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SoCRA Certification Exam 2022 Verified With Complete Solutions.
- Exam (elaborations) • 13 pages • 2022
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Biometrics 
A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) 
 
 
 
Closed System 
An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) 
 
 
 
Digital Signature 
An electronic signature based upon cry...
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