Good Clinical Data Management Practices Questions & Answers Already Passed!!

12 months - Length of certification time for US companies that receive an adequacy determination based on the Safe Harbor Principles 7 Safe Harbor Principles - Security Choice Access Notice Data transfers Enforcement Data integrity Access - Subjects must be able to access information about them that is collected and have an opportunity to have this data corrected or deleted if necessary adequacy determination - given to individual US companies if they meet the privacy standards of the EU; EU commission has ultimate say based on this Choice - Safe Harbor Principle: Subjects must be able to opt out of collection of their data and its transfer to 3rd parties Data integrity - Safe Harbor Principle: Data must be reliable and relevant to the purpose for which it was collected Data Transfers - Safe Harbor Principle: Any transfers of data to third parties must only be to other organizations that have rigorous data-protection policiesDirective 2001/20/EC - subsequent/mandatory and expanded on previous directive in relation to data privacy and informed consent in clinical studies Enforcement - A mechanism must be in place to effectively and consistently enforce these rules EU and US - These two countries have the most impact on clinical research bc of their high volume of research EU Data Protection Directive (95/46/EC) - covers privacy of all types of personal data Minimum standards of data privacy - Training Design CRFs with minimum subject IDers Ensure personal data is not IDable Review and update DM processes to comply with SOPs and govt regs Notice - Safe Harbor Principle: Subjects must be informed of how their data will be collected Privacy protection for subjects - Protocol review and approval by an IRB Right to ICF Right of subject to withdraw consent and have no further data collected Right to notice of disclosure Confidential collection/submission of data