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Clinical Research

Learn the Scientific, Ethical, Practical, Regulatory, and Economic Concepts of Clinical Trials

This program combines business principles, an understanding of the good clinical research practices, and skills necessary for navigating the changing political, regulatory, and financial landscapes.

This Certificate Program will provide the fundamental skills you need to do your job. Topics include, but are not limited to:

  • Overview of drug development
  • Clinical statistics for nonstatisticians
  • Clinical project management
  • Development of a clinical study report
  • Art of writing a clinical overview
  • Oversight of clinical monitoring: trends and strategies

Certificate Program Requirements

To successfully complete this Certificate Program, learners must complete 35 core units and 6 elective units; courses included in this program are noted below:

Course Title
Format
CR Certificate Program Units
Advanced Clinical Statistics for Nonstatisticians
Online
8 Elective Units
Art of Writing a Clinical Overview
Online
4 Core Units
Clinical Project Management
Face-to-face
8 Core Units
Clinical Statistics for Nonstatisticians
Online and Face-to-face
8 Core Units
Clinical Vendor Oversight: Vendor Lifecycle Management for Quality and Performance
Face-to-face
8 Elective Units
Development of a Clinical Study Report
Online and Face-to-face
4 Core Units
Fundamentals of Project Management for Nonproject Managers
Online
4 Elective Units
Key Considerations for the Development and Marketing of Biosimilar Products
Face-to-face
8 Elective Units
Oversight of Clinical Monitoring: Trends and Strategies
Online
4 Core Units
Overview of Drug Development
Face-to-face
4 Core Units
Regulatory Affairs: The IND, NDA and Postmarketing
Face-to-face
16 Elective Units
Strategies for Good Clinical Practice Audits
Online
4 Core Units
The Leadership Experience
Face-to-face
12 Elective Units
* additional meetings and webinars are available to meet the elective unit requirements and will be noted in the upcoming schedule list below

Downloads

Certificate Program Requirements

Electives (Must successfully complete 6 Clinical Research Certificate Program (CRCP) Elective Units)
Course NameCE HoursProgram Units
Clinical Investigator: Module 1 - Study Preparation and Initiation
02/25/2004- 06/01/2015
Location: Online
ACPE 3.50, CME 3.507.00
Clinical Investigator: Module 2 - Conducting the Study
02/25/2004- 06/01/2015
Location: Online
ACPE 3.25, CME 3.257.00
Informed Consent
03/01/2005- 12/31/2016
Location: Online
ACPE 3.501.00
Statistics for Medical Communications Professionals
03/01/2006- 09/25/2016
Location: Online
ACPE 3.50, IACET 3.501.00
DIA/FDA: Revitalizing R&D Productivity in Drug Dev
-
Location:
IACET 13.258.00
Fundamentals of Project Management for Nonproject Managers
04/15/2013- 05/14/2015
Location: Online
None Available4.00
Designed for Success: Utilizing Protocol Quality by Design (QbD) to Plan Clinical Studies
05/01/2014- 04/30/2015
Location: Online
None Available1.00
Pharmacovigilance and Risk Management: Patient Perspective
05/22/2014- 05/21/2015
Location: Online
None Available1.00
Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 1: Fundamentals of Clinical Pharmacology: Pharmacokinetics
07/10/2014- 11/05/2015
Location: Online
None Available1.00
Advanced Clinical Statistics for Nonstatisticians
07/23/2014- 12/31/2015
Location: Online
None Available8.00
Pharmacovigilance and Global Harmonization Updates
07/24/2014- 07/23/2015
Location: Online
None Available1.00
Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 2: Fundamentals of Clinical Pharmacology: Pharmacodynamics
08/07/2014- 11/05/2015
Location: Online
None Available1.00
Five-Part Series on Fundamentals of Clinical Pharmacology For Drug Development - Part 3: Principles of Modeling and Simulation
09/05/2014- 10/31/2015
Location: Online
None Available1.00
Clinical Trials Transparency 3-Part Series: Moving the Debate Forward - Realizing the Benefits of Providing Greater Access to Clinical Trial Data: Part 1 - Paving the Way for Greater Access To Data
09/09/2014- 02/01/2016
Location: Online
None Available1.00
The Role of the Clinical Data Manager
10/08/2014- 10/07/2015
Location: Online
None Available1.00
Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 4: Determining the Safe First Human Dose
10/09/2014- 10/31/2015
Location: Online
None Available1.00
Clinical Trials Transparency 3-Part Series: Moving the Debate Forward-Realizing the Benefits of Providing Greater Access to Clinical Trial Data: Part 2-Connecting the Research Community: Data Sharing–Perspectives from Academia and Patient Advocacy Groups
10/22/2014- 02/01/2016
Location: Online
None Available1.00
Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 5: Assessment of QT Prolongation
11/06/2014- 11/05/2015
Location: Online
None Available1.00
Implementing Risk-Based Monitoring: Practical Approaches
11/13/2014- 12/08/2015
Location: Online
None Available1.00
Clinical Trials Transparency 3 Part Webinar Series - Part 3: Understanding the Legislation Landscape: Regulatory Updates from the FDA, EMA and Health Canada
02/11/2015- 02/01/2016
Location: Online
None Available1.00
Novel Data Sources: The Positive Impact of Social Media and Online Networks for Engaging with Patients
03/04/2015- 03/01/2016
Location: Online
None Available1.00
Oversight of Clinical Monitoring: Trends and Strategies
05/05/2015- 05/07/2015
Location: Online
IACET 6.003.00
DIA Canadian Pharmacovigilance & Risk Management Meeting
05/21/2015- 05/21/2015
Location: Toronto, Canada
IACET 5.504.00
DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.
06/14/2015- 06/18/2015
Location: Washington, DC, United States
ACPE 18.00, CME 18.00, IACET 24.00, PMI 10.00, RN 18.0012.00
#22: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
06/14/2015- 06/14/2015
Location: Washington, DC, United States
IACET 3.252.00
#23: How to Prepare for an FDA Inspection
06/14/2015- 06/14/2015
Location: Washington, DC, United States
CME 3.25, IACET 3.25, RN 3.252.00
#24: Pharmacogenomics and Companion Diagnostics: The Future of Clinical Trials, New Product Development and the Practice of Medicine
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#25: Signal Detection: Identifying and Managing Safety Signals
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#31: Preparing for a US FDA Advisory Committee Meeting
06/14/2015- 06/14/2015
Location: Washington, DC, United States
IACET 3.252.00
#34: Preparation of Risk Evaluation and Mitigation Strategies Assessment Reports
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#35: Ethical Issues in Clinical Trials
06/14/2015- 06/14/2015
Location: Washington, DC, United States
CME 3.25, IACET 3.25, RN 3.252.00
#40: Analysis of Safety Data from Clinical Trials
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
#41: Quality Oversight of CROs-Clinical Vendors
06/14/2015- 06/14/2015
Location: Washington, DC, United States
IACET 6.504.00
#42: Fundamentals of ANDA Submissions and FDA Expectations Under GDUFA
06/14/2015- 06/14/2015
Location: Washington, DC, United States
CME 6.50, IACET 6.50, RN 6.504.00
#43: Clinical Statistics for Nonstatisticians
06/14/2015- 06/14/2015
Location: Washington, DC, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
Regulatory Affairs: The IND, NDA, and Postmarketing
08/10/2015- 08/13/2015
Location: Boston, MA, United States
IACET 30.7516.00
Regulatory Affairs: The IND, NDA, and Postmarketing
11/09/2015- 11/12/2015
Location: Philadelphia, PA, United States
IACET 30.7516.00
Advanced Clinical Statistics for NonStatisticians
11/11/2015- 11/12/2015
Location: Philadelphia, PA, United States
ACPE 11.75, IACET 11.758.00