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Clinical Investigator: Module 1 - Study Preparation and Initiation

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This eLearning program is designed to provide a practical, realistic context in which to help clinical research professionals learn about conducting clinical trials. Using an interactive case study, the program follows the activities of a fictitious clinical investigator and his staff as they conduct a clinical trial for a fictitious drug.

The program is divided into two modules:

  • Module 1 deals with the activities that occur before a clinical trial begins: study preparation and study initiation.
  • Module 2 focuses on activities that occur during the trial.

As learners make decisions during the clinical trial, the program explains how each realistic scenario relates to the regulations, guidelines, and practices for conducting clinical trials.

Featured Topics 

  • Ethics and regulations in clinical research
  • Informed consent process
  • Clinical trial site preparation

Who Should Attend 

  • Physicians
  • Pharmacists
  • Physician assistants
  • Nurse practitioners
  • Research scientists
  • Clinical research professionals

Learning Objectives 

Participants who complete this course should be able to:

  • Differentiate the roles and responsibilities of the clinical investigator, the study staff, and the sponsor with regard to a clinical trial
  • Identify the clinical phases of drug development and what is done at each phase
  • Describe the role and responsibilities of the Institutional Review Board/Independent Ethics Committee with regard to a clinical trial
  • Discuss the regulations and Good Clinical Practice guidelines on conducting a clinical trial
  • Explain the foundations of ethical conduct in clinical research including its impact on clinical research
  • Apply the informed consent process during a clinical trial
  • Explain the history behind human subject protection
  • Prepare a site to conduct a clinical study
  • Organize a site for study initiation, the study initiation meeting, and the investigator meeting

Special Offers 

Save $100.00 by purchasing both Clinical Investigator modules.

Contact Information 

Linda Belmont, DIA
Phone +

Technical Requirements 

Click here for minimum system requirements.


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Continuing Education 

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine (PIM) and DIA. PIM is accredited by the ACCME to provide continuing medical education for physicians.

PIM designates this enduring material for a maximum of 3.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. DIA designates this educational activity for up to 3.5 contact hours or .35 CEUs. 286-000-15-060-H04-P Type of Activity: Application

Release Date: February 2004
Reviewed and Updated: February 22, 2005
Reviewed and Updated: February 27, 2006
Reviewed and Updated: February 26, 2007
Reviewed and updated June 12, 2009
Reviewed and updated March 23, 2010
Reviewed and updated June 1, 2012
Reviewed and updated June 1, 2015
Expiration Date: June 1, 2018*

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

Name Credit Type Max Credits CEU
Clinical Investigator: Module 1 - Study Preparatio ACPE 3.50 0.350
Clinical Investigator: Module 1 - Study Preparatio CME 3.50 0.000

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. Statements 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

The entire Clinical Investigator eLearning Program can be purchased at a 20% discount ($400), which is a $100 discount from the price if each module were purchased individually.

Register Online

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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