The Association of Clinical Research Professionals

Implementing a Patient-Centered Informed Consent Process

Pricing With Contact Hours

Member: $22.50 | Non-Member: $149

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This course is approved for 1.5 ACRP Contact Hours.

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

Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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

Course Description

Improve your consent process by learning how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and address culture, learning styles, emotional states and language.

An effective informed consent process involves more than simply reviewing a document with a potential participant and applying signatures.  This critical process lays the foundation for a subject’s participation in a clinical trial and directly impacts regulatory compliance and site performance with respect to the ability to meet recruitment requirements, achieve and maintain subject compliance, and retain trial subjects.

This eLearning course is essential for those who are directly involved in and responsible for conducting informed consent discussions and developing informed consent forms.  Use the included job aids to immediately take positive actions for your next informed consent discussion.

Estimated time to complete this activity: 90 minutes

Initial Release Date: Coming Soon

Expire Date: Coming Soon

Educational Objectives

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

  • Describe the three critical elements of patient-centered care, which are integral to the consent process.
  • List the ways to ensure understanding during the consent process.
  • Develop a personal action plan to improve your organizational policies and procedures around the consent process.

Competency Domains

This course builds competence in the following domains:

  • Clinical Trials Operations (GCPs)
  • Communication and Teamwork
  • Ethical and Participant Safety Considerations

Learn About Competency Domains for Clinical Research Professionals >>

Target Audience

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

The activity is also intended for clinical research site personnel.

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.

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.


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.



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.


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.