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) Basic

CME/CEU

This course covers the core human subjects research topics for biomedical researchers.

Biomedical (Biomed) Basic

Social-Behavioral-Educational (SBE) Basic

CME/CEU

This course covers the core human subjects research topics for social-behavioral-educational researchers.

Social-Behavioral-Educational (SBE) Basic

Biomedical (Biomed) Refresher 1

CME/CEU

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

Biomedical (Biomed) Refresher 1

Biomedical (Biomed) Refresher 2

CME/CEU

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

Biomedical (Biomed) Refresher 2

Biomedical (Biomed) Refresher 3

CME/CEU

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

Biomedical (Biomed) Refresher 3

Legacy Biomedical (Biomed) Basic

Featured

This legacy version (reflecting the Common Rule’s pre-2018 requirements) of the Biomed Basic course provides an introduction ...

Legacy Biomedical (Biomed) Basic

Legacy Biomedical (Biomed) Refresher

Featured

This legacy version (reflecting the pre-2018 requirements of the Common Rule) provides retraining on the HSR Biomed Basic cours...

Legacy Biomedical (Biomed) Refresher

IRB – Biomedical Focus

CME/CEUNew

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

IRB – Biomedical Focus

IRB – Social-Behavioral-Educational Focus

CME/CEU

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

IRB – Social-Behavioral-Educational Focus

IRB – Biomedical and Social-Behavioral-Educational Combined

CME/CEU

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

IRB – Biomedical and Social-Behavioral-Educational Combined

Comprehensive CIP Course for Advanced Learners

Featured

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

Comprehensive CIP Course for Advanced Learners

CIP Course for Advanced Learners – Biomedical and FDA Research Topics

Featured

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

CIP Course for Advanced Learners – Biomedical and FDA Research Topics

CIP Course for Advanced Learners – Vulnerable Subjects and Consent

Featured

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

CIP Course for Advanced Learners – Vulnerable Subjects and Consent

GCP for Clinical Investigations of Devices

CME/CEUUpdated

This course provides training for research personnel involved in clinical investigations of devices.

GCP for Clinical Investigations of Devices

GCP for Clinical Investigations of Drugs and Devices (FDA)

CME/CEU

Ideal for individuals proposing to conduct clinical trials of drugs, biologics, and devices primarily in the U.S.

GCP for Clinical Investigations of Drugs and Devices (FDA)

GCP for Clinical Investigations of Drugs and Biologics (ICH)

CME/CEU

Ideal for individuals proposing to conduct clinical trials of drugs and biologics in the U.S. or internationally.

GCP for Clinical Investigations of Drugs and Biologics (ICH)

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 Inspections: From Site Preparation to Response
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