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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

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- 12/31/2014
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- 04/14/2015
Location: Online
None Available4.00
CDER Town Meeting: Safety Hot Topics
01/29/2014- 07/28/2014
Location: Online
None Available1.00
Emerging Technologies to Rare Disorder Drug Development: Promises and Pitfalls
02/25/2014- 02/24/2015
Location: Online
None Available1.00
Emerging Technologies to Rare Disorder Drug Development: Promises and Pitfalls
02/25/2014- 02/24/2015
Location: Online
None Available1.00
Key Considerations for the Development and Marketing of Biosimilar Products
04/24/2014- 04/25/2014
Location: Horsham, PA, United States
IACET 13.508.00
Designed for Success: Utilizing Protocol Quality by Design (QbD) to Plan Clinical Studies
05/01/2014- 05/01/2014
Location: Online
IACET 1.501.00
Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline
05/07/2014- 05/09/2014
Location: North Bethesda, MD, United States
ACPE 16.50, CME 16.50, IACET 16.5010.00
Big Data: Impact of Health Care Reform on Collaborations and Strategies
05/19/2014- 05/19/2014
Location: Online
IACET 1.501.00
#32: Pharmacogenomics and Companion Diagnostics: The Future of Clinical Trials, New Product Development and the Practice of Medicine
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
ACPE 3.25, CME 3.25, IACET 3.25, RN 3.252.00
#33: Bayesian Evidence Synthesis and Network Meta-analysis
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#35: Understanding Translational Medicine: Benefits and Innovative Approaches
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
CME 3.25, IACET 3.25, RN 3.252.00
#40: Analysis of Safety Data from Clinical Trials
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
#41: Quality Oversight of CROs-Clinical Vendors
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
IACET 6.504.00
#43: Clinical Statistics for Nonstatisticians
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
ACPE 6.50, CME 6.50, IACET 6.50, RN 6.504.00
DIA 2014 50th Annual Meeting "Celebrate the Past - Invent the Future"
-
Location:
ACPE 18.00, CME 18.00, IACET 24.00, PMI 15.00, RN 18.0012.00
#22: Preparing for a US FDA Advisory Committee Meeting
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
IACET 3.252.00
#24: Successful Drug Development: Best Practices for Clinical Trial Design, Agency Interactions, and Regulatory Document Writing
06/15/2014- 06/15/2014
Location: San Diego, CA, United States
IACET 3.252.00
Advanced Clinical Statistics for Nonstatisticians
07/15/2014- 07/23/2014
Location: Online
ACPE 10.00, IACET 10.008.00
Regulatory Affairs: The IND, NDA, and Postmarketing
08/18/2014- 08/21/2014
Location: Boston, MA, United States
IACET 29.0016.00
Key Considerations for the Development and Marketing of Biosimilar Products
09/09/2014- 09/10/2014
Location: Horsham, PA, United States
IACET 13.508.00
Regulatory Affairs: The IND, NDA, and Postmarketing
11/10/2014- 11/13/2014
Location: Bethesda, MD, United States
IACET 29.0016.00
The Leadership Experience
11/10/2014- 11/12/2014
Location: Bethesda, MD, United States
IACET 22.25, PMI 22.2512.00