Office of Research and Compliance Services

Standard Operating Procedures

Standard Operating Procedures detail the regularly reoccurring work process that may be conducted during a clinical research project. They are prepared to facilitate consistent conformance to maintain quality control, quality assurance, support data quality, and ensure compliance with Creighton University policies and governmental regulations.

These Standard Operating Procedures are dynamic documents under constant thought, formal review, and revision. Please contact David Cloutier, Director of the Clinical Research Office with suggested revisions to these documents or requests for additional Procedures to be added to this catalog.

Clinical Research Standard Operating Procedures
Document	Description
CLN 1.00	SOP Use
CLN 2.00	Study Feasibility
CLN 3.00	Study Approvals
CLN 4.00	Site Qualification
CLN 5.00	Site Initiation
CLN 6.00	Site Monitoring
CLN 7.00	Site Termination
CLN 8.00	Role of Principal Investigator
CLN 9.00	Role of Study Coordinator
CLN 10.00	Delegation of Authority
CLN 11.00	Advertising
CLN 12.00	Obtaining and Documenting Informed Consent
CLN 13.00	Maintaining Subject Confidentiality
CLN 14.00	Document Completion
CLN 15.00	Recording Data in the Case Report Form
CLN 16.00	Preparing and Managing Source Documents
CLN 17.00	Preparing and Managing Case Report Forms
CLN 18.00	Handling General Correspondence
CLN 19.00	Specimen Handling
CLN 20.00	Investigational Product Handling
CLN 21.00	Financial Disclosure
CLN 22.00	Regulatory File Management
CLN 23.00	General Requirements of Informed Consent
CLN 24.00	History and Physical Exam
CLN 25.00	Patient Safety and Comfort
CLN 26.00	Obtaining Vital Signs
CLN 27.00	ECG Procedure
CLN 28.00	Obtaining Urine Sample
CLN 29.00	Obtaining Blood Sample
CLN 30.00	Administering Psychosocial Rating Scales
CLN 31.00	Premature Termination of Study Participant
CLN 32.00	Breaking Study Blind
CLN 33.00	Participant Expectations
CLN 34.00	Emergency Contact
CLN 35.00	Adverse Event (AE)/ Relationship to Study Drug, Device and/or Procedure
CLN 36.00	Adverse Event Reporting
CLN 37.00	Serious Adverse Event Reporting
CLN 38.00	Handling Sponsor or IRB Initiated Audits
CLN 39.00	Handling FDA Audits
CLN 40.00	Obtaining IRB Approval
CLN 41.00	Handling IRB Correspondence
CLN 42.00	Protocol Amendments
CLN 43.00	Documentation and Document Handling
Template	SOP Document Template