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How Do You Develop an Ongoing Training Program for Clinical Research Staff?

Free classes The GCRC has many ongoing programs that people can attend to learn about GCP and practical applications of conducting clinical research safely, under compliance, and ethically. However, there are also some very interesting online courses you and your staff can take for free! When you develop your regulatory binders, make a section for your "Standard Operating Procedure" of how you ensure ongoing clinical trials education for your clinical research enterprise and include some of the following courses and resources.

Principal Investigators — take them all and put together the curriculum that you like best!

Online courses resulting in a printable Certificate of Completion

Great documentation for any visiting regulatory agency who may show up on your doorstep!

Good Clinical Practice Training Lots of the practical aspects of clinical research; regulations, responsibilities, what to expect at a site visit, rules of informed consent and more! There are quizzes at the end of each section and a score over 70% gets you a "Certificate of Completion". (Don't worry; they give you plenty of tries to pass the quizzes).
Collaborative IRB Training Initiative for Protection of Human Subjects Modules are based on issues in biomedical research or social and behavioral research. The course covers all the basics of issues relating to protection of human subjects. Finishing the course results in a "Certificate of Completion". By the way- a "must do" for researchers at UW.
Human Participant Protections Education for Research Teams A free, Web-based course developed at the National Institutes of Health for physicians, nurses, and other members of clinical research teams. A "Certificate of Completion" awaits you at the end of this online course.
Incorporating Cancer Clinical Trials into your Practice For those who are new to the clinical trials research process although cancer based, the information would be applicable to any clinical trial situation. And- when you finish you get a "Certificate of Completion".

Basic information and great food for thought

Interesting and informative lunch-time reading when you and your staff are just sitting around the computer.

General Clinical Research Information
Clinical Trials.gov If someone is coming into your clinical research enterprise with little clinical research experience, it is well worth the time to read each of these links. Describes the process from the patient's standpoint from start to stop.
Good Clinical Practice in FDA-Regulated Clinical Trials FDA's website gives information to investigators regarding their FDA-regulated research. Includes mailing addresses and Frequently Asked Questions.
FDA Warning letters and responses Seriously, this is one of the best sites to learn GCP. Well worth sitting around the campfire and getting yourself scared reading these.
Information for Clinical Investigators Lots and lots of basic, good information from the FDA's Center for Drug Evaluation.
Division of Bioresearch Monitoring (BIMO) Learn all about FDA inspections.
Standards for Clinical Research within the NIH Intramural Research Program An NIH website that lists and describes the standards required for performing clinical research
Clinical Research - The Several C's A video of a lecture by David G. Nathan, MD
Human Subjects Protection
IRB Computer Based Training Want to know what the IRB has to know? Take a computer based training course that NIH provides for it's IRB members but anyone is welcome to wander through.
Guidance for Institutional Review Boards and Clinical Investigators Big FDA index of guidance on protection of human subjects of research
Recommendations to GCRCs for Patient Safety in Clinical Research This document lists recommendations the NCRR has accepted as they relate to patient safety for studies using GCRCs. This site provides rationale and detailed descriptions of why the GCRC requires DSMBs, AE reporting, GMP for biologics and drug administration etc.

Good books on conducting clinical trials

These have been recommended to us by GCRC users:

Do you have a favorite book or resource to share? Send us an email!

More Certificate Programs

These programs offer training and certification at a fee.

UW certificate program in Clinical Trials Offered by the UW Extension
UW certificate program in Biomedical Regulatory Affairs Offered by the UW Extension
Certification by the Association of Clinical Research Professionals The site provides excellent online courses for a fee and membership. The Association offers certification exams.
Certification by SOCRA (Society of Clinical Research Associates) Another society that offers a certification exam. The website contains additional information that is helpful to those interested in clinical research.
top | Site Credits NCRR Funded under NCRR Grant M01-RR-00037 Updated: 10/10/2007 10:08 AM
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