Policies for Good Clinical Practice

	Standard Operating Procedures: For Good Clinical Practice
	Table of Contents
Section 1	Definitions and Acronyms
Section 2	Administration Policies-Overview, Regulatory Support and References
	OCR-ADM-001 -Policy on Standard Operating Procedures ("SOPs") for Research OCR-ADM-002 -Training on, Availability of, and Interpretation of SOPs -Certificate of Acknowledgement -Research SOP Training Attestation Log: Change of SOP
Section 3	Institutional Review Board- Overview, Regulatory Support and References
	OCR-IRB-001 - Institutional Review Board OCR-IRB-002 - Communications with the IRB OCR-IRB-003 - ICH Guidelines for IRB
Section 4	Privacy of Protected Health Information in Research- Overview, Regulatory Support and References
	OCR-PRIV-001 -Identification of Subjects in Communications OCR-PRIV-002 -Certificates of Confidentiality
Section 5	Confidentiality of Research Information- Overview, Regulatory Support and References
	OCR-CON-001 -Research Material Confidentiality
Section 6	General Administrative Policies- Overview, Regulatory Support and References
	OCR-GEN-001 -Credentialing of Physicians or other Staff to Do Research - Training Log OCR-GEN-002.1 -Handling Complaints and Serious/Continuing Noncompliance OCR-GEN-003 - Obtaining Liability Check for Incoming Clinical Trials OCR-GEN-004 - Planning Meetings OCR-GEN-005 -ICH Guidelines for Study Personnel
Section 7	Principal Investigator-Overview, Regulatory Support and References
	OCR-PRI-001 - Principal Investigator Responsibilities OCR-PRI-002 - ICH Guidelines for Principal Investigator OCR-PRI-003 - Principal Investigator Delegation - Delegation of Responsibility Log
Section 8	Protocol-Overview, Regulatory Support and References
	OCR-PRO-001 -ICH Related Guidelines for the Protocol OCR-PRO-002 -Review of Protocol (Industry) for Suitability for the Center/College & Protocol Feasibility Assessment Checklist
Section 9	Informed Consent Policies-Overview, Regulatory Support and References
	OCR-ICF-001 - Policy on Preparation of Informed Consent OCR-ICF-002 - Policy on Obtaining Informed Consent - Form for Documentation of Informed Consent Process OCR-ICF-003 - ICF Guidelines for Informed Consent of Trial Subjects
Section 10	Investigator Initiated Verses Off Label Use-Overview, Regulatory Support
	OCR-IIV-001 - Differentiation Between "Off-Label" Use and Need for IND/IDE
Section 11	Research Documentation Maintenance-Overview, Regulatory Support and References
	OCR-RDM-001 - Required Information in Medical Records OCR-RDM-002.1 - Retention of Research Records OCR-RDM-003 - Access of Records by Auditors OCR-RDM-004 - Storage and Destruction of Paper-Based Research Documentation OCR-RDM-005 - Electronic Communication OCR-RDM-006 - Electronic Source Documents for Clinical Research Study OCR-RDM-007 - Calibration of Equipment
Section 12	HIPAA Research Policy- Overview, Regulatory Support
	OCR-HIP-001 -HIPAA Research Policy: General OCR-HIP-002 -HIPAA Research Policy No 2: IRB Waiver of HIPAA OCR-HIP-003 - HIPAA Research Policy No 3: De-Identified and Decedent OCR-HIP-004 - HIPAA Research Policy No 4: Review Preparatory to Research
Section 13	Investigator Binder/ Essential Documents for a Clinical Trial- Overview, Regulatory Support, and References
	OCR-ED-001 - Essential Documents for a Clinical Trial OCR-ED-002 - Source Documents -Telephone Contact Log OCR-ED-003 - Data Quaries OCR-ED-004 - Guidelines for Writing Notes to the Study File & Note to the Study File Template OCR-ED-005 - ICH Guidelines for Source Documents and Records
Section 14	Recruitment and Retention of Subjects- Overview, Regulatory Support and References
	OCR-RR-001 - Equitable Selection of Subjects OCR-RR-002 - Referencing Investigational Products in Public OCR-RR-003 - Direct Advertising for Study Subjects OCR-RR-004 - Recruiting Patients within NSU Health Care Centers/Clinics and Therapeutic Relationship OCR-RR-005 - Compensation for Research Subjects OCR-RR-006 - Pre-screening of Subjects OCR-RR-007 - Screening/Enrollment Logs - Logs OCR-RR-008 - ICH Guidelines for Compensation to Subjects and Investigators
Section 15	Adverse Events/ SAE and Unanticipated Problems- Overview, Definition and References
	Adverse Event Flowchart Unanticipated Problem Flowchart OCR-AE-001 - Identifying, Handling and Reporting Unanticipated Problems/AEs at NSU Centers/Colleges OCR-AE-002 - Handling Information on Serious Adverse Events from External Sources OCR-AE-003 - ICH Guidelines for Safety Reporting
Section 16	Deviations/Violations- Overview and Regulatory
	OCR-DEV-001 - Protocol Deviations - Protocol Violation/Deviation Form
Section 17	Accountability of Investigational Products- Overview, Regulatory Support and References
	OCR-AIP-001 - Investigational Product/Device Accountability Logs - Investigational Product Accountability Log: Subject Record OCR-AIP-002 - Storage of Investigational Product OCR-AIP-003 - Dispensing for Outpatient Use OCR-AIP-004 - Return to Sponsor or Destruction of Investigational Product OCR-AIP-005 - ICH Guidelines for Drug Accountability
Section 18	Laboratory Process- Overview, Regulatory Support and References
	OCR-LAB-001 - Receipt and Storage of Laboratory Supplies OCR-LAB-002 - Phlebotomy OCR-LAB-003 - Training Requirements for Packaging and Shipping of Specimens
Section 19	Monitoring- Overview, Regulatory Support and References
	OCR-MON-001 - Monitoring OCR-MON-002 - ICH Guidelines for Monitoring Clinical Trials
Section 20	Audits- Sponsor and/or Regulatory (FDA)
	OCR-AUD-001 - Audits- Sponsor and/or Regulatory (FDA)
Section 21	Conflict of Interest- Overview, Regulatory Support and References
	OCR-FC-001 - Financial Conflict of Interest
Section 22	Emergency Procedures- Overview, Regulatory
	OCR- EP-001 - Emergency Procedures
Section 23	Appendix Forms/Logs
	Protocol IND Forms and Instructions Form 1572 Certificate of Acknowledgement Documentation of Consent Process Protocol Violation-Deviation Research SOP Training Attestation Log Supplement to Credentialing Telephone Contact Log Protocol Deviation Log Site Screening and Enrollment Log Protocol Feasibility Assessment Checklist
Section 24	Archiving Changed SOP's- Overview, Regulatory Support and References
	OCR-ACS-001 - Archiving Changed SOP's OCR-GEN-002 - Handling Complaints and Serious/Continuing Non-Compliance OCR-RDM-002 - Retention of Research Records
Section 25	Index