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| 6.1 |
Identifying and Tracking Data Processing and Quality |
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|
| 5.1 |
Adopting EDC Technology: Views from the Site Perspective |
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| 5.2 |
Helping Sites Get Ready: Key Considerations of EDC Deployment |
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| 5.3 |
Improving Data Quality with EDC: Key Process Changes at Investigator Sites |
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| 5.4 |
Beyond Technology: Legal, Ethical, and Financial Challenges for Sites |
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|
| 3.1 |
Understanding Regulations, Guidelines, and Predicate Rules |
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| 3.2 |
Getting Started with Compliance, Part I: Drafting Standard Operating Procedures |
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| 3.3 |
Getting Started with Compliance, Part II: Electronic Records and Signatures |
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| 3.4 |
Getting Started with Compliance, Part III: Validation and Change Control |
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|
| 2.1 |
The New Role of the Clinical Research Associate (CRA) in an Electronic Data Capture (EDC) Environment |
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| 2.2 |
The New Role of the Clinical Data Coordinator (CDC) / Clinical Data Manager (CDM) in an Electronic Data Capture (EDC) Environment |
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| 2.3 |
The New Role of Investigator Site Personnel in an Electronic Data Capture (EDC) Environment |
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| 2.4 |
The New Role of the Clinical Trial Project Managers (CTPM) in an Electronic Data Capture (EDC) Environment |
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|
| 1.1 |
A Historical Review of Electronic Data Capture |
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| 1.2 |
Current State of Clinical Trials Data Collection |
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| 1.3 |
Transition from RDE to Web-based EDC |
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| 1.4 |
Web-based EDC, is it the answer? |
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