№ files_lp_3_process_9_69488
Defines procedures and regulatory requirements for obtaining, certifying, storing, retaining, and destroying printed copies of electronic medical record source documents used in clinical research and monitoring activities.
Year: 2015
Approval Date: 01/01/2015
Effective Date: 01/01/2015
Review/Revision Date: 06/01/2016
Organization: USF Health Medical Clinics
Department: USF Health Medical Records Department
Document Type: Standard Operating Procedure
Subject: Printing and certification of electronic medical record source documents for clinical research
Scope: Clinical research staff abstracting source data and preparing for monitoring visits
Responsible Parties: Investigator and designated research personnel
Regulatory References: 21 CFR Part 11; ICH E6 GCP; HIPAA Privacy & Security Rule (45 CFR Parts 160 and 164)
Related Policies: SOP #202 Privacy and Confidentiality; SOP #310 Site Monitoring Visits; SOP #504 Archiving Study Records
Retention Requirements: In accordance with USF HRPP Policy and Procedure Manual, state and federal laws, and sponsor requirements
Applies To: Outpatient clinical patients evaluated or treated at USF Health Medical Clinics
Price: 8 / 10 USD
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