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First published 1994-4

Japanese Perspectives on Harmonization Initiatives: Problems in Assessing Predrug Approval Clinical Safety Data

Chikayuki Naito

Therapeutic Innovation & Regulatory Science

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Research article

First published 2014-5

Investigation of the Safety Profiles of Japanese Clinical Trials

Kazuhiro Kanmuri, Mamoru Narukawa

Therapeutic Innovation & Regulatory Science

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Review article

First published 2015-9

Safety of Clinical and Non-Clinical Decision Makers in Telephone Triage: A Narrative Review

Sheila Q Wheeler, Mary E Greenberg, Laura Mahlmeister [...]

Journal of Telemedicine and Telecare

Open access

Research article

First published 2025

Impact of social determinants of health on safety of patients in device clinical trials conducted at a safety-net hospital

Anna C. Schneider, Katherine N. Cilley, Marina A. Malikova

Therapeutic Advances in Drug Safety

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Other

First published 1995-4

Clinical Safety,Administration and Data Systems: How Should They be Integrated?

Steve Jolley

Therapeutic Innovation & Regulatory Science

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Research article

First published 2022-7

Clinic Design for Safety During the Pandemic: Safety or Teamwork,Can We Only Pick One?

Lisa Lim, Craig M. Zimring, Jennifer R. DuBose [...]

HERD: Health Environments Research & Design Journal

Open access

Review article

First published 2023

Role of imaging for eligibility and safety of a-NGF clinical trials

Frank W. Roemer, Marc C. Hochberg, John A. Carrino [...]

Therapeutic Advances in Musculoskeletal Disease

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Other

First published 2010-9

Understanding the Differences and Effectively Transitioning between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS)

David N. Schwartz, Michael J. Umen, Kathy Nomides [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2023-8

The effect of clinical risk management training on patient safety competency and related aspects in nursing students

Mahnaz Padash, Sakineh Miri, Mansooreh Azizzadeh Forouzi [...]

Journal of Patient Safety and Risk Management

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Other

First published 2008-7

Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors

Mary Vanderhoof, Michael J. Umen, David N. Schwartz

Therapeutic Innovation & Regulatory Science

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