Content Contributor Diane Paul

Diane Paul, MS, RN

Drug Development Associates, LLC

Diane Paul, MS, RN is currently the Chief Operating Officer of Drug Development Associates, LLC, a clinical development and regulatory strategy company that assists emerging biotechnical and pharmaceutical companies. Ms. Paul has extensive experience and a strong background in pharmaceutical and academic research. She is a graduate of Rutgers University where she received a Master of Science degree in Psychiatric/Mental Health Nursing.
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Biomedical (Biomed) Comprehensive Biomedical (Biomed) Comprehensive
CME/CEU
Series: Human Subjects Research (HSR)

This course provides an expansive review of human subjects research topics for biomedical researchers.

tablet with a 3D brain illuminated at the core
Social-Behavioral-Educational (SBE) Comprehensive Social-Behavioral-Educational (SBE) Comprehensive
CME/CEU
Series: Human Subjects Research (HSR)

This course provides an expansive review of human subjects research topics for social-behavioral-educational researchers.

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Biomedical (Biomed) Refresher 1 Biomedical (Biomed) Refresher 1
CME/CEU
Series: Human Subjects Research (HSR)

This course provides retraining on the HSR Biomed Basic course and discusses core human subjects research topics for biomedical...

tablet with ekg on display along woth a stethoscope
Biomedical (Biomed) Refresher 2 Biomedical (Biomed) Refresher 2
CME/CEU
Series: Human Subjects Research (HSR)

This course provides retraining on the HSR Biomed Basic course and discusses core human subjects research topics for biomedical...

biomedical research doctor reading results on a tablet
Biomedical (Biomed) Refresher 3 Biomedical (Biomed) Refresher 3
CME/CEU
Series: Human Subjects Research (HSR)

This course provides retraining on the HSR Biomed Basic course and discusses core human subjects research topics for biomedical...

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IRB Member – Biomedical Focus IRB Member – Biomedical Focus
CME/CEU
Series: Human Subjects Research (HSR)

Provides foundational training for IRB members involved in the review of biomedical human subjects research.

futuristic interface with medical icons
IRB Member – Social-Behavioral-Educational Focus IRB Member – Social-Behavioral-Educational Focus
CME/CEU
Series: Human Subjects Research (HSR)

Provides foundational training for IRB members involved in review of social-behavioral-educational human subjects research.

Head with multicolored gears as the brain
IRB Member – Biomedical and Social-Behavioral-Educational Combined IRB Member – Biomedical and Social-Behavioral-Educational Combined
CME/CEU
Series: Human Subjects Research (HSR)

Provides foundational training for IRB members involved in the review of both biomedical and social-behavioral-educational huma...

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Comprehensive CIP Course for Advanced Learners Comprehensive CIP Course for Advanced Learners
Featured
Series: Human Subjects Research (HSR)

This course provides advanced learners all the CIP approved modules on topics such as informed consent, U.S. Food and Drug Admi...

professional studying on laptop for the CIP exam
CIP Course for Advanced Learners – Biomedical and FDA Research Topics CIP Course for Advanced Learners – Biomedical and FDA Research Topics
Featured
Series: Human Subjects Research (HSR)

This course provides advanced learners a topic-focused course on biomedical and U.S. Food and Drug Administration (FDA) researc...

pills and bottle used in clinical research with an FDA focus
CIP Course for Advanced Learners – Vulnerable Subjects and Consent CIP Course for Advanced Learners – Vulnerable Subjects and Consent
Featured
Series: Human Subjects Research (HSR)

This course provides advanced learners a topic-focused course on subject population and informed consent topics as well as 9 CE...

Arrows representing vulnerable population in research
GCP for Clinical Investigations of Devices GCP for Clinical Investigations of Devices
CME/CEUUpdated
Series: Good Clinical Practice (GCP)

This course provides training for research personnel involved in clinical investigations of devices in keeping with U.S. FDA regulations and ISO 14155:2020.

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GCP for Clinical Investigations of Drugs and Devices (FDA) GCP for Clinical Investigations of Drugs and Devices (FDA)
CME/CEU
Series: Good Clinical Practice (GCP)

This course is suitable for individuals proposing to conduct clinical trials of drugs, biologics, and devices primarily in the U.S. and/or who need a GCP course aligned with ICH E6(R3) and U.S. FDA regulations.

nurse taking notes
GCP for Clinical Investigations of Drugs and Biologics (ICH) GCP for Clinical Investigations of Drugs and Biologics (ICH)
CME/CEU
Series: Good Clinical Practice (GCP)

This course is suitable for individuals proposing to conduct clinical trials of drugs and biologics in the U.S. and internationally, and who need a GCP course aligned with ICH E6(R3).

Brain neurons firing
FDA Inspections: From Site Preparation to Response FDA Inspections: From Site Preparation to Response
Featured

Covers regulatory inspections of clinical investigators and sites, including mock inspections, 482s, 483s, warning letters, communication, and CAPA plans.

FDA approved medical injection pens
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