Confidentiality (as in data privacy) is the ethical and legal obligation to protect the privacy and sensitive information of study participants. It involves safeguarding data related to a participant's identity, medical history, and study participation, ensuring that such information is disclosed only to authorized individuals for research and regulatory purposes, maintaining trust, and complying with data protection laws.
Confidentiality (as in business relations) is requirement to protect proprietary information, trade secrets, and sensitive data shared between different stakeholders, such as sponsors, Contract Research Organizations (CROs), and research sites. This involves legal and ethical safeguards to prevent the unauthorized disclosure or use of confidential information, ensuring trust, and supporting collaboration in the clinical research industry.
Definitions
ICH E6(R2)
ICH E6 1.16 Confidentiality:
Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity. [1].
See also
Links to this page
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf