Policies for Good Clinical Practice

Table of Contents

Section 1

Definitions and Acronyms (PDF)

Section 2

Administration Policies-Overview, Regulatory Support and References (PDF)

• OCR-ADM-001

  -Policy on Standard Operating Procedures ("SOPs") for Research (PDF)

• OCR-ADM-002

  -Training on, Availability of, and Interpretation of SOPs (PDF)

  -Certificate of Acknowledgement (PDF)

  -Research SOP Training Attestation Log: Change of SOP (PDF)

Section 3

Institutional Review Board- Overview, Regulatory Support and References (PDF)

• OCR-IRB-001

  - Institutional Review Board (PDF)

• OCR-IRB-002

  - Communications with the IRB (PDF)

• OCR-IRB-003

  - ICH Guidelines for IRB (PDF)

Section 4

Privacy of Protected Health Information in Research- Overview, Regulatory Support and References (PDF)

• OCR-PRIV-001

  -Identification of Subjects in Communications (PDF)

• OCR-PRIV-002

  -Certificates of Confidentiality (PDF)

Section 5

Confidentiality of Research Information- Overview, Regulatory Support and References (PDF)

• OCR-CON-001

  -Research Material Confidentiality (PDF)

Section 6

General Administrative Policies- Overview, Regulatory Support and References (PDF)

• OCR-GEN-001

  -Credentialing of Physicians or other Staff to Do Research (PDF)

  - Training Log (PDF)

• OCR-GEN-002.1

  -Handling Complaints and Serious/Continuing Noncompliance (PDF)

• OCR-GEN-003

  - Obtaining Liability Check for Incoming Clinical Trials (PDF)

• OCR-GEN-004

  - Planning Meetings (PDF)

• OCR-GEN-005

  -ICH Guidelines for Study Personnel (PDF)

Section 7

Principal Investigator-Overview, Regulatory Support and References

• OCR-PRI-001

  - Principal Investigator Responsibilities (PDF)

• OCR-PRI-002

  - ICH Guidelines for Principal Investigator (PDF)

• OCR-PRI-003

  - Principal Investigator Delegation (PDF)

  - Delegation of Responsibility Log (PDF)

Section 8

Protocol-Overview, Regulatory Support and References (PDF)

• OCR-PRO-001

  -ICH Related Guidelines for the Protocol (PDF)

• OCR-PRO-002

  -Review of Protocol (Industry) for Suitability for the Center/College &Protocol Feasibility Assessment Checklist (PDF)

Section 9

Informed Consent Policies-Overview, Regulatory Support and References (PDF)

• OCR-ICF-001

  - Policy on Preparation of Informed Consent (PDF)

• OCR-ICF-002

  - Policy on Obtaining Informed Consent (PDF)

  - Form for Documentation of Informed Consent Process (PDF)

• OCR-ICF-003

  - ICF Guidelines for Informed Consent of Trial Subjects (PDF)

Section 10

Investigator Initiated Verses Off Label Use-Overview, Regulatory Support (PDF)

• OCR-IIV-001

  - Differentiation Between "Off-Label" Use and Need for IND/IDE (PDF)

Section 11

Research Documentation Maintenance-Overview, Regulatory Support and References (PDF)

• OCR-RDM-001

  - Required Information in Medical Records (PDF)

• OCR-RDM-002.1

  - Retention of Research Records (PDF)

• OCR-RDM-003

  - Access of Records by Auditors (PDF)

• OCR-RDM-004

  - Storage and Destruction of Paper-Based Research Documentation (PDF)

• OCR-RDM-005

  - Electronic Communication (PDF)

• OCR-RDM-006

  - Electronic Source Documents for Clinical Research Study (PDF)

• OCR-RDM-007

  - Calibration of Equipment (PDF)

Section 12

HIPAA Research Policy- Overview, Regulatory Support

• OCR-HIP-001

  -HIPAA Research Policy: General (PDF)

• OCR-HIP-002

  -HIPAA Research Policy No 2: IRB Waiver of HIPAA (PDF)

• OCR-HIP-003

  - HIPAA Research Policy No 3: De-Identified and Decedent (PDF)

• OCR-HIP-004

  - HIPAA Research Policy No 4: Review Preparatory to Research (PDF)

Section 13

Investigator Binder/ Essential Documents for a Clinical Trial- Overview, Regulatory Support, and References (PDF)

• OCR-ED-001

  - Essential Documents for a Clinical Trial (PDF)

• OCR-ED-002

  - Source Documents (PDF)

  -Telephone Contact Log (PDF)

• OCR-ED-003

  - Data Quaries (PDF)

• OCR-ED-004

  - Guidelines for Writing Notes to the Study File & Note to the Study File Template (PDF)

• OCR-ED-005

  - ICH Guidelines for Source Documents and Records (PDF)

Section 14

Recruitment and Retention of Subjects- Overview, Regulatory Support and References (PDF)

• OCR-RR-001

  - Equitable Selection of Subjects (PDF)

• OCR-RR-002

  - Referencing Investigational Products in Public (PDF)

• OCR-RR-003

  - Direct Advertising for Study Subjects (PDF)

• OCR-RR-004

  - Recruiting Patients within NSU Health Care Centers/Clinics and Therapeutic Relationship (PDF)

• OCR-RR-005

  - Compensation for Research Subjects (PDF)

• OCR-RR-006

  - Pre-screening of Subjects (PDF)

• OCR-RR-007

  - Screening/Enrollment Logs (PDF)- Logs (PDF)

• OCR-RR-008

  - ICH Guidelines for Compensation to Subjects and Investigators (PDF)

Section 15

Adverse Events/ SAE and Unanticipated Problems- Overview, Definition and References (PDF)

• Adverse Event Flowchart (PDF)

• Unanticipated Problem Flowchart (PDF)

• OCR-AE-001

  - Identifying, Handling and Reporting Unanticipated Problems/AEs at NSU Centers/Colleges (PDF)

• OCR-AE-002

  - Handling Information on Serious Adverse Events from External Sources (PDF)

• OCR-AE-003

  - ICH Guidelines for Safety Reporting (PDF)

Section 16

Deviations/Violations- Overview and Regulatory

• OCR-DEV-001

  - Protocol Deviations (PDF)
  - Protocol Violation/Deviation Form (PDF)

Section 17

Accountability of Investigational Products- Overview, Regulatory Support and References (PDF)

• OCR-AIP-001

  - Investigational Product/Device Accountability Logs (PDF)

  - Investigational Product Accountability Log: Subject Record (PDF)

• OCR-AIP-002

  - Storage of Investigational Product (PDF)

• OCR-AIP-003

  - Dispensing for Outpatient Use (PDF)

• OCR-AIP-004

  - Return to Sponsor or Destruction of Investigational Product (PDF)

• OCR-AIP-005

  - ICH Guidelines for Drug Accountability (PDF)

Section 18

Laboratory Process- Overview, Regulatory Support and References (PDF)

• OCR-LAB-001

  - Receipt and Storage of Laboratory Supplies (PDF)

• OCR-LAB-002

  - Phlebotomy (PDF)

• OCR-LAB-003

  - Training Requirements for Packaging and Shipping of Specimens (PDF)

Section 19

Monitoring- Overview, Regulatory Support and References (PDF)

• OCR-MON-001

  - Monitoring (PDF)

• OCR-MON-002

  - ICH Guidelines for Monitoring Clinical Trials (PDF)

Section 20

Audits- Sponsor and/or Regulatory (FDA)

• OCR-AUD-001

  - Audits- Sponsor and/or Regulatory (FDA) (PDF)

Section 21

Conflict of Interest- Overview, Regulatory Support and References (PDF)

• OCR-FC-001

  - Financial Conflict of Interest (PDF)

Section 22

Emergency Procedures- Overview, Regulatory (PDF)

• OCR- EP-001

  - Emergency Procedures (PDF)

Section 23

Appendix Forms/Logs

• Protocol IND Forms and Instructions (PDF)

• Form 1572 (PDF)

• Certificate of Acknowledgement (PDF)

• Documentation of Consent Process (PDF)

• Protocol Violation-Deviation (PDF)

• Research SOP Training Attestation Log (PDF)

• Supplement to Credentialing (PDF)

• Telephone Contact Log (PDF)

• Protocol Deviation Log (PDF)

• Site Screening and Enrollment Log (PDF)

• Protocol Feasibility Assessment Checklist (PDF)

Section 24

Archiving Changed SOP's- Overview, Regulatory Support and References (PDF)

• OCR-ACS-001 - Archiving Changed SOP's (PDF)

• OCR-GEN-002 - Handling Complaints and Serious/Continuing Non-Compliance (PDF)

• OCR-RDM-002 - Retention of Research Records (PDF)

Section 25

Index (PDF)