Policies & Procedures
PSoM Policies and Procedures
Compliance SOP — which govern the overview of the PSOM OCR compliance programs including format, standards and scope of review
SOP 200 — Compliance Reviews
SOP 201 — Regulatory Inspections
SOP 203 — FDA Form 1572 Policy
Finance SOP — which details the roles and responsibility associated with PennChart Billing Review, PennChart Account Maintenance and PennChart Research Records.
SOP 300 — Research Billing Compliance Review
Sponsor SOP — which detailed the roles and responsibilities associated with being a Sponsor at the Perelman School of Medicine.
SOP 001 – Sponsor Responsibilities
SOP 002 — Vendor Selection and Qualification
SOP 003 — Investigational Product Management
SOP 004 – Monitoring
SOP 005 – Pharmacovigilance and Safety Reporting
Systems SOP — detailing the requirements associated with registration and patient tracking in the Penn Clinical Trial Management System – Penn CTMS
SOP 400 — CTMS Requirements
Training SOP — which specifies the required training for faculty, staff and residents with respect to the conduct of research within PSoM.
Site Operations SOP — which outline procedures or responsibilities of the Principal Investigator (PI) of a site at Penn Medicine.
The Institutional Review Board (IRB) — SOPs
- EPIC EMR Policy
- FDA Form 1572 Policy
- Research/Sponsored Programs Policies & Procedures
- Research Training Policy (CITI)
- Security of Electronic Protected Health Information (ePHI) Policy
Best Practice Guidelines
- Good Clinical Practice
- Ethical Principles
- Social Media Guidance — Guidance documents below will direct you to the IRB website, please contact the email@example.com for approvals
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