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CTTI

Clinical Trials Transformation Initiative

Publications

Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative

Posted on June 17, 2016February 5, 2025 by Hannah Faulkner

Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative

Posted in Informed Consent, Informed Consent, Publications, Related: Informed Consent, Safety, Study Design, Study Operations

Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?

Posted on May 18, 2016February 17, 2025 by Hannah Faulkner

Recent Clinical Trials in Osteoporosis: A Firm Foundation or Falling Short?

Posted in Clinical Trials Landscape, Publications, Related: State of Clinical Trials, State of Clinical Trials, State of Clinical Trials Annual Report

Barriers to Change in the Informed Consent Process: A Systematic Literature Review

Posted on May 17, 2016February 5, 2025 by Hannah Faulkner

Barriers to Change in the Informed Consent Process: A Systematic Literature Review

Posted in Informed Consent, Informed Consent, Publications, Related: Informed Consent, Safety, Study Design, Study Operations

Enhancing clinical evidence by proactively building quality into clinical trials

Posted on April 21, 2016February 10, 2025 by Hannah Faulkner

Enhancing clinical evidence by proactively building quality into clinical trials

Posted in Ensuring Quality, Publications, Quality by Design, Quality By Design, Related: Quality By Design, Study Design

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

Posted on March 11, 2016February 6, 2025 by Hannah Faulkner

Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

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

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey

Posted on October 14, 2015February 7, 2025 by Hannah Faulkner

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey

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

The FDA’s Final Rule on Expedited Safety Reporting: Statistical Considerations

Posted on October 9, 2015February 11, 2025 by Hannah Faulkner

The FDA’s Final Rule on Expedited Safety Reporting: Statistical Considerations

Posted in Publications, Related: Safety Reporting, SAE Reporting, Safety, Safety Reporting, Study Operations

Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov

Posted on September 11, 2015February 17, 2025 by Hannah Faulkner

Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov

Posted in ABDD Unmet Need, Antibacterial Drug Development-Unmet Need, Clinical Trials Landscape, Ensuring Quality, Publications, Regulatory Submissions + Approvals, Related: ABDD Unmet Need, Related: State of Clinical Trials, Safety, State of Clinical Trials, State of Clinical Trials Annual Report, Study Design

Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey

Posted on September 3, 2015February 10, 2025 by Hannah Faulkner

Barriers to Clinical Trial Recruitment and Possible Solutions: A Stakeholder Survey

Posted in Ensuring Quality, Publications, Recruitment, Recruitment, Recruitment, Related: Recruitment, Study Design, Study Operations

Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel

Posted on July 15, 2015March 31, 2025 by Hannah Faulkner

Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel

Posted in Informed Consent, Publications, Related: Informed Consent

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DISCLAIMER: CTTI encourages the use of all materials listed on this site in the pursuit of improving the clinical trials enterprise. Our recommendations, tools, meeting summaries, and more are available to the public for free. We do ask that you acknowledge the source whenever using or referencing CTTI materials. Read our Citation Policy. 

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