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CTTI

Clinical Trials Transformation Initiative

Safety

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

Sample Tiered Informed Consent Model

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

Sample Tiered Informed Consent Model

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

Informed Consent Training Resources

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

Informed Consent Training Resources

Posted in Informed Consent, Informed Consent, Resources, Safety, Study Design, 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

Considerations to Support Communication between Institutions and Outside IRBs when Responsibilities are Being Assigned for Multicenter Clinical Trial Protocols

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

Considerations to Support Communication between Institutions and Outside IRBs when Responsibilities are Being Assigned for Multicenter Clinical Trials Protocols

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

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

Recommendations for Desired Attributes of Electronic Portals for Expedited Safety Reporting

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

Recommendations for Desired Attributes of Electronic Portals for Expedited Safety Reporting

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

Recommendations for Data Monitoring Committees

Posted on June 7, 2021January 31, 2025 by Hannah Faulkner

Recommendations for Data Monitoring Committees

Posted in Data Monitoring Committees, Data Monitoring Committees, Ensuring Quality, Recommendations, Safety, Study Operations

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