The Association of Clinical Research Professionals

Introduction to Good Clinical Practice

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Member: $99 | Non-Member: $149

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This course is approved for 2.0 ACRP Contact Hours, 2.0 AMA PRA Category 1 Credit(s)™ for physicians, and 2.0 contact hours for nurses (full accreditation details below)

This eLearning course will be accessible for up to one year from the date of purchase.


Course Description

An essential course for all clinical research professionals. Good Clinical Practice is the international industry standard for designing, conducting, recording, and reporting clinical trials. This interactive self-paced course encompasses the recent Integrated Addendum to Good Clinical Practice, or E6(R2), as it’s commonly referred to.

Ensure patient safety and well-being and data quality and integrity by following the guidelines of the International Council for Harmonisation’s Good Clinical Practice (ICH GCP).

This course is an excellent starting point for anyone wanting to begin work in clinical research and a great refresher for those who have been in the role for some time.

Learn the globally recognized standard for conducting ethical and scientifically sound research and to “speak” the universal language of clinical research. Achieve excellence in your work through the proper application of International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) guidelines. This interactive eLearning course incorporates real-world scenarios you’re likely to encounter during a clinical trial.

This training meets the minimum criteria for ICH GCP Investigator Site Personnel training identified by TransCelerate BioPharma, Inc.

Estimated time to complete this activity: 120 minutes

Initial Release Date: Coming Soon

Expire Date: Coming Soon


Educational Objectives

After completing this activity, the participant should be better able to:

  • List the key drivers that led to the formation of International Council for Harmonisation (ICH) for GCP.
  • Explain the key considerations to be made with regard to GCP during a clinical trial.
  • Describe the roles and responsibilities of a sponsor, an investigator, and the IRB/IEC.
  • Explain the Adverse Event reporting requirements for both the sponsor and the investigator.
  • List the core requirements for securing the informed consent of study participants.
  • Describe the importance of protocol compliance and clear documentation in the clinical trial process.
  • Define the purpose of various documents and templates that members use in the clinical trial process.

Target Audience

This activity is intended for Physicians and Nurses engaged in the care of patients within a clinical research trial.

This activity is also intended for all clinical research professionals.


Accreditation Statements

The Association of Clinical Research Professionals (ACRP) provides contact hours for the completion of this live educational activity with the completion of the online evaluation form. These contact hours can be used to meet the ACRP certification maintenance requirement.

Joint Provider LogoIn support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and the Association of Clinical Research Professionals. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

  • Physician Continuing Medical Education

The Postgraduate Institute for Medicine designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  • Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 2.0 contact hours.

For any questions relating to CME (physician) or CNE (registered nurse) certification for this activity, please contact Postgraduate Institute for Medicine at: inquries@pimed.com or (303) 799-1930.


Method of Participation and Request for Credit

Once you have completed the interactive portion of the course you will need to complete the evaluation before a certificate of completion will be made available to you.


Faculty

Bridget Gonzalez, CCRC
Director, Training and Professional Development
Association of Clinical Research Professionals


Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Bridget Gonzalez, CCRC
Director, Training and Professional Development
Association of Clinical Research Professionals
Nothing to Disclose

Planners and Managers
The PIM planners and managers have nothing to disclose. The ACRP planners and managers have nothing to disclose.


Media

Internet


Computer System Requirements

This course is intended to be used with any internet browser such as Chrome, Firefox, Safari or Internet Explorer. For the interactive content of this course to work properly, you must enable Flash on this website. If adjusting the setting does not result in the course running properly, you may need to contact your Network or IT administrator for authorization to do this on your network. Indications that Flash is not enabled are: video with no audio, audio with no video, a click doesn’t respond, you are unable to resume, etc.


Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.


Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management.  Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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