Office of Human Research
Page Title
SOP No.: 600 SUBJECT MANAGEMENT |
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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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This procedure describes the preparation, review, and approval of the informed consent form, and documentation of the informed consent process.
SOP No. 602: Subject Recruitment Practices
This procedure describes the steps for conducting participant recruitment for FDA-regulated human subject research within Thomas Jefferson University.
SOP No. 603: Subject Screening and Enrollment
This procedure describes the process to be followed for confirming the eligibility of participants to participate in Food and Drug Administration (FDA)-regulated human subject research.
SOP No. 604: Specimen Management
This procedure describes the steps for fulfilling the Investigator’s instructions and other applicable regulatory and clinical requirements involved in specimen collection and handling.
SOP No. 605: Adverse Event Recognition and Reporting
This procedure describes the regulatory requirements for identifying, investigating and reporting adverse events that occur in individuals who are participating in any clinical study.
