Online Training Tools for Clinical Research Coordinators

by Andrew Milroy – HRPP and CQA Manager (Merita CQA)

Online training is becoming increasingly popular in nearly every field allowing for training of professionals from the comfort of their own office or home. In the field of clinical research there are several well known online training tools such as the TCPS 2 CORE Tutorial offered by the Interagency Advisory Panel on Research Ethics, and the Collaborative Institutional Training Initiative’s (CITI) ICH GCP training.

Listed below are six online training tools, including those mentioned above, that offer clinical research coordinators a means by which they can upgrade their credentials, refresh their knowledge, or just remain current with the latest developments and ideas.

The TCPS 2 Tutorial – Course on Research Ethics (CORE)

CORE provides an applied approach to the guidance provided in TCPS 2. This self-paced course is a media-rich learning experience that features interactive exercises and multi-disciplinary examples. CORE consists of eight modules ranging from Core Principles to REB Review. It is designed primarily for the use of researchers and REB members – though anyone may take this course and print their own certificate of completion.

http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/

Collaborative Institutional Training Initiative’s (CITI) Program’s Good Clinical Practice (GCP)

GCP courses are suitable for research teams involved in clinical trials of drugs, biologics, and devices.

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA focus) is suitable for individuals proposing to conduct clinical trials of drugs and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.

GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) is suitable for individuals involved in clinical trials on drugs and biologics when the research may be international or where the individuals would prefer a more ICH-focused curriculum. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

GCP for Clinical Trials with Investigational Medical Devices is most appropriate for organizations or individuals who desire a more international-focused GCP curriculum or a more device-focused program.

https://www.citiprogram.org/

 

Ethical and Regulatory Aspects of Clinical Research

This course is offered by the NIH to anyone interested or involved in the ethics of clinical research with human subjects. Participants represent multiple disciplines including research teams, IRB members, physicians, psychologists, nurses, social workers, administrative staff, students, and others.

http://www.bioethics.nih.gov/courses/index.shtml#ethical

Introduction to the Principles and Practice of Clinical Research (IPPCR)

The Introduction to the Principles and Practice of Clinical Research (IPPCR) is offered by NIH and is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. Other areas covered include data management and ethical issues, including protection of human subjects, building a budget, plus many special topics.

http://clinicalcenter.nih.gov/training/training/ippcr.html

Training and Resources in Research Ethics Evaluation (TRREE)

TRREE is headed by a consortium of interested persons from Northern and Southern countries. It aims to provide basic training, while building capacities, on the ethics of health research involving humans so that research meets highest standards of ethics and promotes the welfare of participants. TRREE achieves this goal primarily by developing a training programme with local collaborators. In its initial stages TRREE focused primarily, but not exclusively, on the needs of African countries.

TRREE provides free-of-charge access to:

e-Learning: a distance learning program and certification on research ethics evaluation

e-Resources: a participatory web-site with international, regional and national regulatory and policy resources

The e-learning programme is based on internationally recognized ethical principles and regulations. It integrates local issues and perspectives from low-and middle-income countries, most notably from African countries, that are relevant to all those who must ensure the protection of research participants and who promote highest ethical standards.

http://elearning.trree.org/

The Lab: Avoiding Research Misconduct

In “The Lab: Avoiding Research Misconduct,” you become the lead characters in an interactive movie and make decisions about integrity in research that can have long-term consequences. The simulation addresses Responsible Conduct of Research topics such as avoiding research misconduct, mentorship responsibilities, handling of data, responsible authorship, and questionable research practices.

http://ori.hhs.gov/thelab

This list is not exhaustive and if you are aware of other available online training tools please feel free to contact me so that I can review and consider utilizing them for training purposes.

I can be reached at amilroy@meritacqa.com if you have any questions or would like to share additional online training tools.

References:

TCPS 2 Tutorial :: The Interagency Advisory Panel on Research Ethics (PRE). (n.d.). Retrieved December 3, 2014, from http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/

Collaborative Institutional Training Initiatives. (n.d.). Retrieved December 3, 2014, from https://www.citiprogram.org/

Courses, Lectures, & Training. (n.d.). Retrieved December 3, 2014, from http://www.bioethics.nih.gov/courses/index.shtml#ethical

NIH Clinical Center: IPPCR. (n.d.). Retrieved December 3, 2014, from http://clinicalcenter.nih.gov/training/training/ippcr.html

TRAINING AND RESOURCES IN RESEARCH ETHICS EVALUATION. (n.d.). Retrieved December 3, 2014, from http://elearning.trree.org/

The Lab. (n.d.). Retrieved December 3, 2014, from http://ori.hhs.gov/thelab