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Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer

JAMA : the journal of the American Medical Association, 2017-02, Vol.317 (6), p.606

2017

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Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule

Annals of the New York Academy of Sciences, 2016-06, Vol.1374 (1), p.10-16

2016

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Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

Therapeutic innovation & regulatory science, 2021-01, Vol.55 (1), p.6-18

2021

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Monitoring the quality of conduct of clinical trials: a survey of current practices

Clinical trials (London, England), 2011-06, Vol.8 (3), p.342-349

2011

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Regulatory Considerations for Digitally Driven Trials

Applied clinical trials, 2022-06, Vol.31 (6), p.34-34

Mitchel, Jules T

2022

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WHAT IS A CRO?

Applied clinical trials, 2022-03, Vol.31 (3), p.9-9

Mitchel, Jules T

2022

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Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database

Drug information journal, 2011-07, Vol.45 (4), p.421-430

2011

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Risk-Based Source Data Verification Approaches: Pros and Cons

Drug information journal, 2010-11, Vol.44 (6), p.745-756

2010

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Regulatory Considerations for 21st Century Paperless Trials

Applied clinical trials, 2017-04, Vol.26 (4/5), p.25

2017

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Analysis: FDA's COVID-19 Accelerated Pathways: Lessons learned from FDA's current process and proposed alternative review strategies

Applied clinical trials, 2021-12, Vol.30 (12), p.22

2021

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Analysis: FDA's COVID-19 Accelerated Pathways

Applied clinical trials, 2021-12, Vol.30 (12), p.22-26

2021

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EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM

Endocrine practice, 2017-05, Vol.23 (5), p.557-565

2017

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The Transformation of Clinical Trials: From writing on papyrus to the world of technology

Applied clinical trials, 2022-01, Vol.31 (1-2), p.16

2022

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The Transformation of Clinical Trials

Applied clinical trials, 2022-01, Vol.31 (1/2), p.16-20

2022

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Adopt eSource Solutions

Applied clinical trials, 2012-10, Vol.21 (10), p.18

Mitchel, Jules T

2012

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Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality

Therapeutic innovation & regulatory science, 2015-11, Vol.49 (6), p.903-910

2015

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Extended Risk-Based Monitoring Model, On-Demand Query-Driven Source Data Verification, and Their Economic Impact on Clinical Trial Operations

Therapeutic innovation & regulatory science, 2016-01, Vol.50 (1), p.115-122

2016

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Using the internet to enhance drug safety monitoring from phase 1 to phase 4 in dermatology clinical trials

Journal of the American Academy of Dermatology, 2004-03, Vol.50 (3), p.P82-P82

2004

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eSource Records in Clinical Research: Keeping it Simple

Applied clinical trials, 2015-08, Vol.24 (8/9), p.30

2015

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eSource records in clinical research: keeping it simple: how to satisfy regulatory concerns about EDC data integrity and site controls over its source records

Applied clinical trials, 2015-08, p.30

2015

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Three-pronged approach to optimizing trial monitoring: study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry

Applied clinical trials, 2014-06, Vol.23 (6-7), p.37

2014

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Three-Pronged Approach to Optimizing Trial Monitoring

Applied clinical trials, 2014-06, Vol.23 (6/7), p.37

2014

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Risk-based approaches: the eClinical Forum risk based monitoring taskforce offers some best practices for ensuring clinical data quality

Applied clinical trials, 2013-07, Vol.22 (7-8), p.26

2013

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Risk-Based Approaches

Applied clinical trials, 2013-07, Vol.22 (7/8), p.26

2013

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Topical Alprostadil in the Treatment of Female Sexual Arousal Disorder: A Pilot Study

Journal of sex & marital therapy, 2001-10, Vol.27 (5), p.531-540

2001

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Association Between Use of a Scalp Cooling Device and Alopecia After Chemotherapy for Breast Cancer

Working with the U.S. Food and Drug Administration to obtain approval of products under the Animal Rule

Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative

Monitoring the quality of conduct of clinical trials: a survey of current practices

Regulatory Considerations for Digitally Driven Trials

WHAT IS A CRO?

Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database

Risk-Based Source Data Verification Approaches: Pros and Cons

Regulatory Considerations for 21st Century Paperless Trials

Analysis: FDA's COVID-19 Accelerated Pathways: Lessons learned from FDA's current process and proposed alternative review strategies

Analysis: FDA's COVID-19 Accelerated Pathways

EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM

The Transformation of Clinical Trials: From writing on papyrus to the world of technology

The Transformation of Clinical Trials

Adopt eSource Solutions

Risk-Based Monitoring: A Closer Statistical Look at Source Document Verification, Queries, Study Size Effects, and Data Quality

Extended Risk-Based Monitoring Model, On-Demand Query-Driven Source Data Verification, and Their Economic Impact on Clinical Trial Operations

Using the internet to enhance drug safety monitoring from phase 1 to phase 4 in dermatology clinical trials

eSource Records in Clinical Research: Keeping it Simple

eSource records in clinical research: keeping it simple: how to satisfy regulatory concerns about EDC data integrity and site controls over its source records

Three-pronged approach to optimizing trial monitoring: study results using a quality-by-design method, risk-based monitoring, and real-time direct data entry

Three-Pronged Approach to Optimizing Trial Monitoring

Risk-based approaches: the eClinical Forum risk based monitoring taskforce offers some best practices for ensuring clinical data quality

Risk-Based Approaches

Topical Alprostadil in the Treatment of Female Sexual Arousal Disorder: A Pilot Study

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