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CTTI

Clinical Trials Transformation Initiative

Publications

High-Intensity Statin Use Among Patients With Atherosclerosis in the U.S.

Posted on May 5, 2022March 31, 2025 by Hannah Faulkner

High-Intensity Statin Use Among Patients With Atherosclerosis in the U.S.

Posted in Electronic Healthcare Data, Publications

Can Quality Management Drive Evidence Generation?

Posted on November 2, 2021June 6, 2025 by Hannah Faulkner

Can Quality Management Drive Evidence Generation?

Posted in Ensuring Quality, Publications, Quality by Design

Stakeholders’ recommendations for revising Good Clinical Practice

Posted on June 21, 2021February 5, 2025 by Hannah Faulkner

Stakeholders’ recommendations for revising Good Clinical Practice

Posted in Ensuring Quality, Informing ICH E6 Renovation, Informing ICH E6 Renovation, Publications, Related: Informing ICH E6 Renovation, Study Design

Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance

Posted on May 21, 2021February 11, 2025 by Hannah Faulkner

Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance

Posted in Publications, Related: Single IRB, Safety, Single IRB, Single IRB, Study Operations

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Posted on February 12, 2021February 11, 2025 by Hannah Faulkner

Investigator Experiences Using Mobile Technologies in Clinical Research: Qualitative Descriptive Study

Posted in Data Collecting and Reporting, Digital Health Technologies, Innovative Trials, Managing Data, Managing Data, Publications, Related: Managing Data, Related: Selecting and Testing Digital Health Technology, Related: Testing a Digital Health Technology, Selecting and Testing Digital Health Technology, Study Design, Study Operations, Testing a Digital Health Technology

Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative

Posted on January 3, 2021February 10, 2025 by Hannah Faulkner

Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative

Posted in Publications, Real World Data, Recruitment, Related: Real World Data, RWD for Eligibility and Recruitment, Site Planning, Study Design

Assessing the Financial Value of Patient Engagement

Posted on December 10, 2020February 7, 2025 by Hannah Faulkner

Assessing the Financial Value of Patient Engagement

Posted in Patient Engagement, Patient Group Engagement, Publications, Related: Patient Group Engagement, Study Design

Prospective Identification of Pneumonia in Hospitalized Patients in the ICU

Posted on December 1, 2020October 4, 2024 by Hannah Faulkner

Prospective Identification of Pneumonia in Hospitalized Patients in the ICU

Posted in ABDD HABP/VABP, Antibacterial Drug Development-HABP/VABP Studies, Publications, Related: ABDD HABP/VABP

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

Posted on September 29, 2020February 7, 2025 by Hannah Faulkner

Development and Application of a Patient Group Engagement Prioritization Tool for Use in Medical Product Development

Posted in Patient Engagement, Patient Group Engagement, Patient Group Engagement, Publications, Related: Patient Group Engagement, Study Design

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

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