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CTTI

Clinical Trials Transformation Initiative

Study Operations

New Resources for Designing and Running Master Protocols Webinar Slides

Posted on October 13, 2020February 6, 2025 by Hannah Faulkner

New Resources for Designing and Running Master Protocols Webinar Slides

Posted in Innovative Trials, Master Protocol Studies, Master Protocols, Related: Master Protocol Studies, Resources, Study Design, Study Operations

Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data

Posted on September 1, 2020February 5, 2025 by Hannah Faulkner

Investigators from Multiple U.S. Organizations Collaborate on First Embedded Pragmatic Clinical Trial Using National Health Plans’ Data 

Posted in Data Collecting and Reporting, Electronic Healthcare Data, Electronic Healthcare Data, Innovative Trials, Press Releases, Related: Electronic Healthcare Data, Study Design, Study Operations

More than a Box to Check: Research Sponsor and Investigator Perspectives on Making GCP Training Relevant

Posted on August 13, 2020February 6, 2025 by Hannah Faulkner

More than a Box to Check: Research Sponsor and Investigator Perspectives on Making GCP Training Relevant

Posted in Investigator Qualification, Investigator Qualification, Publications, Related: Investigator Qualification, Site Planning, Study Operations

Master Protocol Design & Implementation: Charting Multi-Stakeholder Pathways to Success

Posted on June 25, 2020February 6, 2025 by Hannah Faulkner

Master Protocol Design & Implementation: Charting Multi-Stakeholder Pathways to Success

Posted in Innovative Trials, Master Protocol Studies, Master Protocols, Resources, Study Design, Study Operations

CTTI Novel Endpoints Interactive Selection Tool

Posted on June 24, 2020February 21, 2025 by Hannah Faulkner

CTTI Novel Endpoints Interactive Selection Tool

Posted in Developing Novel Endpoints, Innovative Trials, Novel Endpoints, Primary, Regulatory Submissions + Approvals, Resources, Study Design, Study Operations

Appendix 1: Resources for Training and Learning

Posted on June 8, 2020February 6, 2025 by Hannah Faulkner

Appendix 1: Resources for Training and Learning

Posted in Investigator Qualification, Investigator Qualification, Resources, Site Planning, Study Operations

Table: Approaches for Safety Monitoring & Managing Safety Signals when using Digital Health Technologies for Data Capture

Posted on June 7, 2020February 6, 2025 by Hannah Faulkner

Table: Approaches for Safety Monitoring & Managing Safety Signals when using Digital Health Technologies for Data Capture

Posted in Data Collecting and Reporting, Innovative Trials, Managing Data, Managing Data, Resources, Study Design, Study Operations

Table: Promoting & Protecting Data Integrity

Posted on June 7, 2020February 6, 2025 by Hannah Faulkner

Table: Promoting & Protecting Data Integrity

Posted in Data Collecting and Reporting, Innovative Trials, Managing Data, Managing Data, Resources, Study Design, Study Operations

Table: CTTI Recommended Strategies for Optimizing Data Quality

Posted on June 7, 2020February 6, 2025 by Hannah Faulkner

Table: CTTI Recommended Strategies for Optimizing Data Quality

Posted in Data Collecting and Reporting, Innovative Trials, Managing Data, Managing Data, Resources, Study Design, Study Operations

Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials

Posted on March 7, 2020February 6, 2025 by Hannah Faulkner

Continued investigator engagement: Reasons principal investigators conduct multiple FDA-regulated drug trials

Posted in Investigator Community, Investigator Community, Publications, Related: Investigator Community, Site Planning, Study Operations

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