• What is HIPAA?
• How Do You Register Clinical Trials with The FDA?
• Clinical Trial Terminology - Glossary and Acronyms
• How can I get into clinical research?
• Are there any clinical research courses?
• Are there any schools with specifically designed curriculums in clinical research offered by institutions of higher learning?
• What salary might I expect in clinical research?
• GCP Fact or Fiction Review Document (PDF)
• GCP Questions for The FDA
• New FDA Guidance on Investigator Responsibilities
• Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions - Statement of Investigator (Form FDA 1572)
• How do I get answers to questions I have concerning the FDA regulations?
• Are there any books on clinical research and/or clinical trials?

What is HIPAA?

Click Here for an article (PDF) on the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, which focuses on its impact on research and researchers.

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How Do You Register Clinical Trials with The FDA?

Click Here to learn more.

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Clinical Trial Terminology - Glossary and Acronyms

Click Here for Clinical Trial Terminology - Glossary and Acronyms!

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How can I get into clinical research?

• Join SoCRA - this will allow you to begin networking and understand the roles in clinical research.  You will receive four SoCRA Source magazines per year and the opportunity to attend our annual conference, which has educational sessions at a reduced rate.
• Attend our educational programs beginning with the Clinical Science Course which is a five day workshop aimed at those new to the field and those wanting a refresher.   See Educational Workshops for more information.
• Certification is recommended.  If eligible (see Certification for more information), the member will have the opportunity to sit for the certification exam.  For those not eligible, the opportunity will still be there when they meet eligibility requirements.  A study guide is available and this is a good reference tool to have even if not taking the exam.  The cost is $50.00 if purchased separately, and it is included in the cost of registration to take the examination.
• Subscribe to Applied Clinical Trials (web site www.actmagazine.com) and perhaps Research Nurse (web site www.researchnurse.com). Both journals are excellent in the way of educating the clinical research professional and introducing the reader to the many career opportunities.
• Internet: Do your homework... browse and read about clinical research companies, associations, latest technologies and other like organizations to keep up with what is going on in the field.
• Lastly, talk to others in the field and ask them what they do and how. Become familiar with all the different aspects of clinical research and position yourself to be "in the know."

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Are there any clinical research courses?

Yes, many clinical research courses with non-profit organizations like SoCRA, ACRP, DIA, SCDM, and SCT offer courses in the form of one to two day workshops for specific topics and a combination of topics.  SoCRA offers a 5-day course.  Other courses are available through commercial training companies like Center Watch and The Center for Clinical Research Practice.

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How do I get answers for FDA regulations questions?

Click here for a listing of FDA small business representatives in your area.

www.fda.gov/ora/fed_state/Small_business/sb_guide/smbusrep.html

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Are there any schools with specifically designed curriculums in clinical research offered by institutions of higher learning?

Structured curriculums are available at colleges and universities throughout the U.S.

Information about programs of which we are aware follows. This is by no means a complete listing - but just a starting point from which you may begin your search for educational opportunities in the field of Clinical Research.

What salary might I expect in clinical research?

See www.salary.com, where you can select a position and location and receive the latest results of their studies.

Click Here for the SoCRA Salary Survey (PDF, 506KB).

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GCP Fact or Fiction Review Document

Click Here for the review document (PDF, 74KB).

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GCP Questions for The FDA

Send the FDA your GCP Question:
gcpquestions@oc.fda.gov

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New FDA Guidance on Investigator Responsibilities

FDA has issued final guidance on "Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects." The guidance document is now available from FDA's website using the following web link: Click Here (PDF).

This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). The goal of this guidance is to help investigators better meet their responsibilities with respect to protecting human subjects and ensuring the integrity of the data from clinical investigations. This guidance is intended to clarify for investigators and sponsors FDA’s expectations concerning the investigator’s responsibility (1) to supervise a clinical study in which some study tasks are delegated to employees or colleagues of the investigator or other third parties and (2) to protect the rights, safety, and welfare of study subjects.

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Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs
Frequently Asked Questions - Statement of Investigator (Form FDA 1572)

Click Here for the review document (PDF, 673KB).

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Books by Bert Spilker, PhD, MD

• Guide to Clinical Studies and Developing Protocols, Raven Press, 1984
• Guide to Clinical Interpretation of Data, Raven Press, 1986
• Guide to Planning and Managing Multiple Clinical Studies, Raven Press, 1987
• Multinational Drug Companies: Issues in Drug Discovery and Development, Raven Press, 1989
• Inside the Drug Industry With Pedro Cuatrecasas, Prous Science Publishers, 1990
• Quality of Life Assessments in Clinical Trials, Editor, Raven Press, 1990
• Presentation of Clinical Data, With John Schoenfelder, Raven Press, 1990
• Patient Compliance in Medical Practice and Clinical Trials, Edited with Joyce Cramer, Raven Press, 1991
• Guide to Clinical Trials, Raven Press, 1991 and CD Rom version in 1997
• Data Collection Forms in Clinical Trials, with John Schoenfelder, Raven Press, 1991
• Patient Recruitment in Clinical Trials, with Joyce Cramer, Raven Press, 1992
• Multinational Pharmaceutical Companies: Principles and Practices (2nd Ed.), Raven Press, 1994
• Medical Dictionary in Six Languages, Raven Press, 1995
• Quality of Life and Pharmacoeconomics in Clinical Trials (2nd Ed.), Lippincott-Raven, 1996
• Introduction to Quality of Life and Pharmacoeconomics, With Joyce Cramer, Lippincott-Raven, 1997
• Guide to Drug Development: A Comprehensive Review and Assessment, Lippincott, Williams & Wilkins, 2008

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