Guest guest Posted August 11, 2010 Report Share Posted August 11, 2010 Hi, While reviewing a clinical trial protocol it is also the responsibility of the EC to ensure that it includes adequate information to protect the confidentiality of research participants. A check-list to ensure this would be: • Description of individuals, who will have access to personal data of the research participants, including medical records and biological samples. • Measures taken to ensure the confidentiality and security of personal information concerning research participants. • Extent to which the information will be anonymised. • How long the data/samples will be kept. • Adequacy of the process for obtaining consent for the above. Dr. Smita Quote Link to comment Share on other sites More sharing options...
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