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- Patients & Families
-
Scientists
- Overview
- Clinical Research Execution
- Recruitment: Strategies, Resources, Privacy
-
Protocol Development
- Overview
- Study Design
- Protocol Writing
- Cohort Identification and Feasibility
- Protocol Design
- Informed Consent Development
- Oversight & Study Team Members
- Regulatory Applications
- Service Providers and Third Parties
- Risk Assessment and Data Safety Monitoring Boards
- Safety Oversight
- Product Development
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Regulatory Applications
- Overview
- Step 1: Determining if you’re using an FDA-regulated Drug or Medical Device
- Step 2: Determining the FDA Regulatory Requirements for use of your Drug or Medical Device (IND or IDE Exemption)
- Step 3: Intellectual Property Consultation
- Step 4: Sponsor Registration
- Step 5: Preparing an FDA Regulatory Application or Exemption
- Preparatory to Study Initiation
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Study Execution
- Overview
- Source Documentation
- Informed Consent Process
- Screening and Enrolling Subjects
- Patient Reported Outcomes
- Protocol Modifications
- Monitoring
- Data Management
- Remote Trials
- Studies with PHI Disclosed Outside of Penn
- Research Do Not Contact
- FDA Submissions and Lifecycle Management
- Decentralized Trials
- Monitoring during the Trial
- Published
- Study Close Out
- Learning Health System Research
- Learning Health System Science
- Office of Clinical Research
- Research Resources
- Clinical Research Cores
- Training for Scientists
- Training
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Clinical Research Professionals
- Overview
- Clinical Research Professional Roles
- Clinical Research Execution
- Research Technology
- Coverage Analysis Review (CAR)
- Compliance Services
- Monitoring Content
- Research Billing in PennChart
- Coverage Analysis
- Trainings
- Finance
- Clinical Research Operations/CRCs
- Specific Training
- Clinical Research Cores
- Research Support Offices
- Forms, Tools and Templates
- Policies, Procedures & Guidance
- Community
- Education and Training
- News Archive
- Submit a Clinical Research Workshop Idea
- Penn Highlights in Clinical Research