Clinical Investigator: Module 1 - Study Preparation and Initiation

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Overview

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.

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 +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements

Click here for minimum system requirements.

Author(s)

Previous Next

Karen E. Woodin, PhD

President
JKK Consulting LLC, United States

Continuing Education

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

Postgraduate Institute for Medicine designates this educational activity for a maximum of 3.5 AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

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 3.5 contact hours or .35 CEUs. 286-000-12-085-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
Expiration Date: June 1, 2015*

*In order to receive any continuing education credit for this module, you must complete the module and pass the module exam by midnight on 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 mailed 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

Individual: $250.00

Group Discounts

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.

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.