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 202 — Report of Compliance concerns in Clinical Research

SOP 203 — FDA Form 1572 Policy

SOP 204 — Dissemination Plan for CT Results for NIH-Funded CT: Clinicaltrials.gov Requirements


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


Manufacturing SOP 

SOP 100 — Manufacturing Qualification, Registration and Training 


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

SOP 006 — Sponsor Qualification, Registration and Training 


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.

SOP 401 — Clinical Research Training for PSOM Faculty and Staff


Site Operations SOP — which outline procedures or responsibilities of the Principal Investigator (PI) of a site at Penn Medicine.

SOP 204 — Use of Controlled Substances in Clinical Research


The Institutional Review Board (IRB) — SOPs

Research Policies 

Perelman School of Medicine Policies

University of Pennsylvania Health System Policies


Best Practice Guidelines