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Premarketing Clinical Trial Safety

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This module is part of the DIA Drug Safety eLearning Program. The Premarketing Clinical Trial Safety module provides a framework and details around drug safety requirements for clinical trials for drugs in humans. This module provides information about safety and ethical safeguards in place to protect human subjects in clinical trials: informed consent, institutional review boards and ethics committees, and data safety monitoring boards. It will provide the details on individual case reporting and aggregate reporting requirements. Finally, the module will discuss risk assessment and the premarketing review of safety data in an application.

Featured Topics 

  • Informed Consent
  • Institutional Review Board and Ethics Committee
  • Data and Safety Monitoring Boards
  • Individual Case Reporting
  • Aggregate Reporting
  • Risk Assessment
  • Premarketing Review of Safety Data in an Application

Who Should Attend 

Professionals working in the area of:

  • Drug safety & pharmacovigilance
  • Clinical research and development
  • Marketing approval
  • Regulatory affairs
  • Medical affairs
  • Quality assurance/compliance
  • Anyone who would like to enhance their knowledge and understanding of drug safety

Learning Objectives 

Upon completion of this course, participants should be able to:

  • Discuss the purpose of  informed consent in clinical trials
  • Identify the elements of informed consent in clinical trials
  • Define the roles of institutional review boards, ethics committees, and data and safety monitoring boards in clinical trials
  • Explain premarketing individual case reporting and aggregate reporting requirements
  • Discuss risk assessment in clinical trials
  • Explain the premarketing review of safety data in an application

Special Offers 

Save 20% by purchasing all six modules in Drug Safety eLearning Program for $1,920 (a $480 savings).  Save 10% on the purchase of two to five modules.

Contact Information 

Linda Belmont, DIA
Phone +

Technical Requirements 

Click here for minimum system requirements.

Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 4.0 contact hours or .4 CEUs. 0286-0000-14-413-H04-P Type of Activity: Application

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .4 CEUs for this program.

This eLearning module is part of DIA’s Certificate Program and is awarded the following: • Clinical Safety and Pharmacovigilance Certificate Program: 2 Elective Units
If you successfully complete all six modules in the Drug Safety eLearning Program, the Elective Units will be converted into the required Core Units in the Clinical Safety and Pharmacovigilance Certificate Program. For more information go to www.diahome.org/certificateprograms

Release Date: June 30, 2014
Expiration Date: June 30, 2017*

*Continuing education credit is available to participants who successfully complete the eLearning program before the expiration date.

Name Credit Type Max Credits CEU
Premarketing Clinical Trial Safety ACPE 4.00 0.400
Premarketing Clinical Trial Safety IACET 4.00 0.400

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

In order to receive a statement of credit (before the one year purchase expiration date and before the expiration date listed above), please review the entire module, complete the exam and evaluation form. You must receive a passing score of 80% or better to receive a statement of credit. A statement of credit will be emailed within one month of receipt of exam and evaluation form. Please note: If you do not complete the module, pass the module exam, AND complete the evaluation form, you will not receive a statement of credit.

Registration Fees 

Other Fees

Group Discounts\Registration

Save 20% by purchasing all six modules in Drug Safety eLearning Program for $1,920 (a $480 savings).  Save 10% on the purchase of two to five modules.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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