Thomas Jefferson University

Main menu:

Standard Operating Procedures for Good Clinical Practices

Table of Contents

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