| Online Class: Research Quality: Handling Investigational Drug Products 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.
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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.
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Course Lessons Optional Certificates Awarded - Certificate of Attendance
- Certificate of Class Participation
- 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 |
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