Online Course: Research Quality: Handling Investigational Drug Products - Certificate and CEUs
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Online Class: Research Quality: Handling Investigational Drug Products

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Course Cost
Basic Course: $35.00
with Certificate & CEUs: $60.00
An investigational drug product, often referred to as "IP", is the pharmaceutical form of an active ingredient generally tested in a clinical trial and used for an unapproved indication, or used to gain further information about an approved drug product. Most of the medication available to you from your physician and your pharmacist was at one time an 'investigational drug product'. Investigational drug products are developed and tested to provide relief to those suffering from various diseases such as ALS, AIDS, cancer, heart trouble, headaches, etc. to prove the investigational drug can ease the suffering brought on by these diseases.
 
This course is designed for all clinicians conducting clinical research. Specifically, CRAs, Research Coordinators, Investigators, Sub-Investigators, Auditors, Project Managers and any other individual involved with handling investigational materials will benefit from taking this course.
 
Good Clinical Practices regulations require that researchers have continuous training. This course may satisfy that requirement. We will discuss the regulatory requirements for sponsors handling investigational drug products and the requirements at an investigator's sites. We will learn how to perform drug accountability and drug compliance calculations. A sample Temperature/Humidity Log  will be included in this course to provide guidance on how to maintain required environmental records.
Enroll today! This is a self-paced, online course. You have 6 months to finish. An instructor will monitor your progress and assess your body of work at course completion. UniversalClass™ offers many wonderful learning tools to help you get the most out of your online course, including an online portfolio service that manages all your course completions.

If you would like to receive more information regarding this course, scroll down and fill out the "Request More Information" form and we'll try to answer any of your questions within the day.

Continuing Education Units (CEU)
1.0 CEUs

Course Description

Good Clinical Practices regulations require that researchers have continuous training. This course may satisfy that requirement. We will discuss the regulatory requirements for sponsors handling investigational drug products and the requirements at an investigator's sites. We will learn how to perform drug accountability and drug compliance calculations. A sample Temperature/Humidity Log  will be included in this course to provide guidance on how to maintain required environmental records. 

 

Who should attend?  This course is designed for all clinicians conducting clinical research. Specifically, CRAs, Research Coordinators, Investigators, Sub-Investigators, Auditors, Project Managers and any other individual involved with handling investigational materials will benefit from taking this course.

This course offers 1.0 CEUs upon successful completion. You may take this online course with or without CEU documentation. An online and hard-copy Certificate of Course Completion displaying your coursework and CEUs earned is included with the CEU Option. We also offer an expedited Transcript Service for sending your accomplishments to a third party.

Course Lessons

  1. Introduction to Handling Investigational Products - This class gives a quick overview of the sponsor and investigator investigational drug product handling requirements. It also reviews common clinical research terms found throughout the course.
  2. Labeling an Investigational Drug Product - This lesson will review the FDA and Health Canada Protection Branch content requirements for investigational product's label .
  3. Control of Investigational Drug Products - This class reviews the type of controls expected for investigational drug products.
  4. Storage and Environmental Monitoring - This class describes storage and documentation requirements for investigational products.
  5. Subject's Compliance and Accountability - This class shows how to calculate subjects' drug compliance and investigational product reconciliation. It also provides a sample inventory log.
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Optional Certificates Awarded

  1. Certificate of Attendance
  2. Certificate of Class Participation
  3. Certificate of Academic Excellence

Certificates awarded by the instructor will vary and are based upon student merit. Any awards you earn are considered unofficial (or temporary) unless you decide to make the award official. To make an award official, there is a $30.00 processing fee that covers the customization, printing, and shipping of a hard copy of the certificate as well as access to the UniversalClass™ Transcript Service. Official awards include a serial number that verifies the authenticity of the award you earned for a lifetime (great for employers to verify your achievement).

Additional Information

Course Title : Research Quality: Handling Investigational Drug Products
CEU Value : (Continuing Education Units)
Course Number : 33637
Course Type : Professional (Intermediate Level)
Course URL : http://qualitytrialsip.onlineclasses.com
Course Review :
Instructor : Sarah Wilson
Syllabus : View Syllabus
Duration : Continuous: Enroll anytime!
Course Fee :
Basic Course: $35.00
with CEUs & Certificate: $60.00
NOT FOR COLLEGE CREDIT
This is a non-credit course. This course may not fulfill any local, state, government, licensing, or educational requirements.
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Document your coursework with a Certificate of Course Completion. Pre-pay now for the Certificate Option and receive a $5.00 discount off the regular certificate price (normally $30.00). Includes both an online version and a hard-copy of your certificate, verified and tracked by a unique serial number.


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