Good Clinical Practice
Standard Operating Procedures detail the regular work processes that may be conducted during a clinical research project. They are designed to help researchers maintain consistent quality control and quality assurance, support data quality, and ensure compliance with Creighton University policies and governmental regulations.
Introduction
Conducting a Study
- Study Feasibility Review for Sponsored Clinical Research
- Creighton University Approvals of Sponsored Research and Clinical Trials
- Site Qualification Visit
- Site Initiation Visit
- Site Monitoring Visits
- Site Termination Visits
- Advertising
- Investigational Product Handling
- Maintaining Subject Confidentiality
- Study Participant Safety and Comfort
- Premature Termination or Withdrawal of a Study Participant
- Breaking Study Blind
- Emergency Contact
- Adverse Event (AE)/Relationship to Study Drug, Device, and/or Procedure
- Adverse Event Reporting
- Serious Adverse Event Reporting
Roles and Responsibilities
- Role of the Principal Investigator
- Role of the Study Coordinator
- Documenting Delegation of Authority
Informed Consent and Other Documentation
- Obtaining and Documenting Informed Consent
- General Requirements of Informed Consent
- Document Completion
- Preparing and Managing Source Documents
- Recording Data in the Case Report Form
- Preparing and Managing Case Report Forms
- Handling General Correspondence
- Financial Disclosure
- FDA Drug-Device Regulatory File Management
- Documentation and Document Handling
Clinical Procedures
- Specimen Handling
- History and Physical Exam
- Obtaining Vital Signs
- ECG Procedure
- Obtaining a Urine Sample
- Obtaining a Blood Sample
- Administering Psychosocial Rating Scales
IRB and Regulatory Agencies
- Obtaining IRB Approval
- Handling IRB Communication
- Protocol Modifications
- Handling Sponsor or Research and Compliance Audits
- Handling FDA Audits
