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
- Roles and Responsibilities
- Informed Consent and Other Documentation
- Clinical Procedures
- IRB and Regulatory Agencies
- 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
Informed Consent and Other Documentation
- Obtaining and Documenting Informed Consent
- Attachment: Study Participant Bill of Rights
- Attachment: Informed Consent Process Progress Note
- 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
- Specimen Handling
- History and Physical Exam
- Obtaining Vital Signs
- ECG Procedure
- Obtaining a Urine Sample
- Obtaining a Blood Sample
- Administering Psychosocial Rating Scales
- Obtaining IRB Approval
- Handling IRB Communication
- Protocol Modifications
- Handling Sponsor or Research and Compliance Audits
- Handling FDA Audits
Confidential Research Hotline (402-280-3200)
Research Personnel are expected to report any known or suspected noncompliant conduct related to research or sponsored program activities conducted and/or approved through Creighton University. The confidential Research Compliance Hotline (402-280-3200) is available for any individual who wishes to remain anonymous and/or has found other available reporting mechanisms to be ineffective. Research Personnel may also address their research compliance-related questions or concerns to Kathy Taggart, Associate Vice President for Research and Compliance, at 402-280-2360.
