Office of Human Research
Page Title
SOP No.: 700 DATA 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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SOP No. 701: Case Report Forms
This procedure describes the process for designing, reviewing, approving, and revising case report forms (CRFs) that will be used to collect protocol-specified data during a clinical study intended to collect safety and/or efficacy data on an unapproved use of a drug, biologic or medical device (the investigational product).
SOP No. 702: Clinical Research Data Management
This procedure describes the processes for the collection and transcription of clinical research data to case report forms (CRFs) or other related forms, and the management of the data, including procedures for quality control, data query resolution, record retention and archiving.
SOP No. 703: Use of Electronic Data Systems
This procedure serves as a companion to SOP 702, Clinical Research Data Management. It provides additional guidance concomitantly required when all or portions of the clinical data that are required by an FDA predicate rule for a submission or inspection are collected, managed and/or transmitted electronically, or include the use of electronic signatures in required records.
