Office of Human Research
Page Title
SOP No.: 900 PRIVACY PRACTICES |
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Author: Office of Human Research |
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Effective Date: October 1, 2007 |
Supercedes document dated: N/A |
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Last Reviewed on: N/A |
Results of Review: N/A |
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This SOP pertains to: All SOPs used in FDA-regulated human subject research within Thomas Jefferson University |
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Responsibility for executing this SOP: Investigator and Designated Research Personnel |
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Approved By:
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR) |
Approved By:
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR) |
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SOP No. 901: Safeguarding Protected Health Information
This standard operating procedure (SOP) describes the steps taken to ensure that subject protected health information (PHI) is kept confidential and access to such information is limited to authorized research staff for approved purposes only. Access to confidential information should only be permitted for direct subject management, administrative oversight, or with Institutional Board approval. Maintaining high standards of conduct with respect for the privacy of individuals and the confidentiality of information is essential for all personnel involved with the conduct of clinical research.
SOP No. 902: Information Access Control
This standard operating procedure (SOP) describes the steps taken to ensure that subject protected health information (PHI) is controlled and access to such information is limited to authorized research staff for approved purposes only. Adequate password protection is vital to safeguarding PHI and must be limited to research staff who require access to this information. Therefore, each user of PHI will be identified and allowed access to information based on his/her assigned password.
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