Office of Clinical Research

• Policies & Procedures

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

SOP 206 — ClinicalTrials.gov

Attachment — ClinicalTrials.gov Attachment for SOP 206

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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

SOP 301 — NETC Parallel Review

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Manufacturing SOP 

SOP 100 — Manufacturing Qualification, Registration and Training 

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REDCap PSOM OCR

SOP 405 — REDCap Training and Access

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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 

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Systems SOP — detailing the requirements associated with registration and patient tracking in the Penn Clinical Trial Management System – Penn CTMS

SOP 400 — CTMS Requirements

SOP 402 — PennChart Research Associations 

SOP 403 — PennChart Research Study Maintenance

SOP 404 — PennChart Research Billing

SOP 407 — PennVault Training Access

SOP 408 — PennVault eTMF Study Access 

SOP 409 — Veeva SVE Access Change Control 

SOP 410 — Research Honest Broker Access Process

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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

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

SOP 204 — Use of Controlled Substances in Clinical Research

SOP 406 — External Remote Monitoring

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Site Operations SOP — the Office of Clinical Research (OCR) Standard Operating Procedure (SOP) Process

SOP 000 — OCRs SOPs

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The Institutional Review Board (IRB) — SOPs

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Research Policies 

• EPIC EMR Policy (UPHS login may be required)
• Research/Sponsored Programs Policies & Procedures
• Research Training Policy (CITI)
• Security of Electronic Protected Health Information (ePHI) Policy

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Perelman School of Medicine Policies

University of Pennsylvania Health System Policies

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Best Practice Guidelines

• Good Clinical Practice
• Ethical Principles
• Social Media Guidance — Guidance documents below will direct you to the IRB website, please contact the pennmedicinesocialmediacommittee@uphs.upenn.edu for approvals
  • Social Media Guidance Document
  • Penn School of Medicine Social Media Handbook
  • Penn School of Medicine Social Media Proposal Form 
  • Penn School of Medicine Social Media Template Language for Subjects
  • Working with Penn Medicine Communications