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CTTI

Clinical Trials Transformation Initiative

Recommendations

Recommendations for Strengthening the Investigator Site Community

Posted on June 8, 2021February 6, 2025 by Hannah Faulkner

Recommendations for Strengthening the Investigator Site Community

Posted in Investigator Community, Investigator Community, Recommendations, Site Planning, Study Operations

Recommendations for Informed Consent

Posted on June 8, 2021February 5, 2025 by Hannah Faulkner

Recommendations for Informed Consent

Posted in Informed Consent, Informed Consent, Recommendations, Safety, Study Design, Study Operations

Recommendations for Good Clinical Practice (GCP) Training for Investigators

Posted on June 8, 2021February 6, 2025 by Hannah Faulkner

Recommendations for Good Clinical Practice (GCP) Training for Investigators

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

Recommendations for Improving Reporting of Unexpected Serious Adverse Events (SAEs) to Investigation New Drug (IND) Investigators

Posted on June 8, 2021February 11, 2025 by Hannah Faulkner

Recommendations for Improving Reporting of Unexpected Serious Adverse Events (SAEs) to Investigation New Drug (IND) Investigators

Posted in Recommendations, SAE Reporting, Safety, Safety Reporting, Study Operations

Executive Summary: Recommendations for Patient Group Engagement

Posted on June 8, 2021February 7, 2025 by Hannah Faulkner

Executive Summary: Recommendations for Patient Group Engagement

Posted in Patient Engagement, Patient Group Engagement, Patient Group Engagement, Patient-centered, Recommendations, Study Design

Recommendations for Developing Novel Endpoints Generated by Digital Health Technology for Use in Clinical Trials

Posted on June 7, 2021July 8, 2021 by Hannah Faulkner

Recommendations for Developing Novel Endpoints Generated by Digital Health Technology for Use in Clinical Trials

Posted in Recommendations

Recommendations for Optimizing Mobile Clinical Trials by Engaging Patients and Sites

Posted on June 7, 2021July 8, 2021 by Hannah Faulkner

Recommendations for Optimizing Mobile Clinical Trials by Engaging Patients and Sites

Posted in Recommendations

Recommendations for Using Single IRBs (sIRB) for Multicenter Clinical Trials

Posted on June 7, 2021July 3, 2025 by Hannah Faulkner

Recommendations for Using Single IRBs for Multicenter Clinical Trials

Posted in Recommendations, Safety, Single IRB, Single IRB, Study Operations

Recommendations for Advancing the Use of Single IRBs (sIRB) for Multicenter Clinical Trials

Posted on June 7, 2021July 3, 2025 by Hannah Faulkner

Recommendations for Advancing the Use of Single IRBs for Multicenter Clinical Trials

Posted in Recommendations, Safety, Single IRB, Single IRB, Study Operations

Recommendations for IND Safety Assessment and Communication

Posted on June 7, 2021February 11, 2025 by Hannah Faulkner

Recommendations for IND Safety Assessment and Communication

Posted in Recommendations, SAE Reporting, Safety, Safety Reporting, Study Operations

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