13
19
19
30
11
15
11
15
15
29
11
11
11
11
18
7d Sitemap
19 19 19 31 19 65 19 7d
24
1f
31
1
19
19
45
1d
1d
39
1d
1d
39
1d
1d
39
1d
1d
1d
20
19
19
19
3e
1b
-
6f
- Patients & Families
-
1c
Scientists
9
-
135
- Overview
- Clinical Research Execution
- Recruitment: Strategies, Resources, Privacy
-
26
Protocol Development
9
-
46d
- 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
-
2a
Regulatory Applications
9
-
3bb
- 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
- 31 Preparatory to Study Initiation 9 19
-
21
Study Execution
9
-
565
- 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
- 21 Study Close Out 9 15f
- Learning Health System Research
- Learning Health System Science
- Office of Clinical Research
- 24 Research Resources 9 78
- Clinical Research Cores
- 29 Training for Scientists 9 58
- Training
-
31
Clinical Research Professionals
9
-
6a
- Overview
- 36 Clinical Research Professional Roles 9 296
- Clinical Research Execution
- Research Technology
- Coverage Analysis Review (CAR)
- Compliance Services
- Monitoring Content
- Research Billing in PennChart
- Coverage Analysis
- 1b Trainings 9 19
- 19 Finance 9 19
- 33 Clinical Research Operations/CRCs 9 1ff
- Specific Training
- Clinical Research Cores
- Research Support Offices
- Forms, Tools and Templates
- Policies, Procedures & Guidance
- Community
- 28 Education and Training 9 142
- News Archive
- Submit a Clinical Research Workshop Idea
- Penn Highlights in Clinical Research b
19
31
37
19
19
1b