Office of Human Research
Standard Operating Procedures for
Good Clinical Practices
Introduction    |    SOP Table of Contents

Table of Contents

GA 100 GENERAL ADMINISTRATION
GA 101 Standard Operating Procedure (SOP) Preparation and Maintenance
GA 102 Document Development and Change Control
GA 103 Investigator Responsibility and Delegation of Responsibility
GA 104 Study Team Training
GA 105 Prohibition of Financial Conflicts

RA 200 REGULATORY AFFAIRS
RA 201 Contacts and Submissions for FDA
RA 202 Reporting Requirements for the FDA under an IND or IDE
RA 203 NIH Requirements for OBA-Reviewed Research

PD 300 PROTOCOL DEVELOPMENT
PD 301 Clinical Protocol Development, Implementation and Compliance
PD 302 Clinical Protocol Amendments
PD 303 Investigator’s Brochure

SS 400 STUDY START-UP
SS 401 Investigator Selection
SS 402 Initiation Visit

PM 500 PROJECT MANAGEMENT
PM 501 Communication
PM 502 Investigational Product Inventory Management
PM 503 Documentation and Records Retention
PM 504 Routine Monitoring Visits
PM 505 Study Closeout

SM 600 SUBJECT MANAGEMENT
SM 601 Informed Consent
SM 602 Subject Recruitment Practices
SM 603 Subject Screening and Enrollment
SM 604 Specimen Management
SM 605 Adverse Event Recognition and Reporting

DM 700 DATA MANAGEMENT
DM 701 Case Report Forms
DM 702 Clinical Research Data Management
DM 703 Use of Electronic Data Systems

QA 800 QUALITY ASSURANCE
QA 801 QA Audits
QA 802 FDA Inspection

PP 900 PRIVACY PRACTICES
PP 901 Safeguarding Personal Health Information
PP 902 Information Access Control

 


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