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