• What is HIPAA?
• How does AAHRPP’s Standard I.7.A. pertain to IRB approval of protocols for Phase 1 trials?
• 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?
• Is there any development in new Regulatory Science Courses? New!
• 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 does AAHRPP’s Standard I.7.A. pertain to IRB approval of protocols for Phase 1 trials?

To Accredited Independent IRBs:

Recently, we were asked to clarify AAHRPP’s Standard I.7.A. pertaining to IRB approval of protocols for Phase 1 trials, specifically the issue of whether an IRB can approve advertising, recruiting, and screening procedures to begin prior to the end of the 30-day FDA review period or prior notification from FDA. The IND regulations at 21 CFR 312.20(b) state "A sponsor shall not begin a clinical investigation subject to 312.2(a) until the investigation is subject to an IND which is in effect in accordance with 312.40." Recruiting, obtaining consent and screening subjects for a specific study that is subject to an IND is considered "beginning the clinical investigation" and such activities cannot be performed until an IND is in effect (30 days after FDA receives the IND, or earlier if the sponsor is so notified by FDA). Recruiting, obtaining consent and screening subjects for an IND study prior to the IND being in effect is not in compliance with the FDA regulations or AAHRPP Standard I.7.A.

This means that your IRB(s) may not approve a Phase 1 trial and allow the CRO or research site to start recruiting, enrolling or screening subjects prior to the IND going into effect. If you issue IRB approval for a Phase 1 trial prior to the IND going into effect, you must advise the CRO or research site that the IRB approval is not effective until the IND goes into effect and any other approvals are obtained. You have options, though, as to how you may handle these protocols. For example, you may approve the trial and inform the CRO and site not to begin, you may withhold IRB approval until the IND goes into effect, or you may approve the trial but delay sending the approval letter until the IND goes into effect.

If you have questions you may contact me or the Office of Good Clinical Practice at FDA at gcp.questions@fda.hhs.gov. If sponsors, CROs or investigators challenge you on this position, please refer them to the Office of Good Clinical Practice at FDA.

I would like to point out that you may approve general screening protocols for Phase 1 units as long as they are not specific to a particular study and not subject to an IND. Additional information can be found in FDA's Information Sheets at the following web link: www.fda.gov/RegulatoryInformation/Guidances/ucm126430.htm.

Marjorie A. Speers, Ph.D.
President and CEO

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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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Is there any development in new Regulatory Science Courses?

University of Pennsylvania Survey for Master’s of Science Degree Program in the Field of Regulatory Science

This survey may be accessed at www.surveymonkey.com/s/WKC9N8K

The University of Pennsylvania is designing a Master’s of Science degree program in the field of Regulatory Science in partnership with the FDA. A 25 question (5 minutes or less to respond) survey has been created to ascertain the interest level for such a program and obtain input from research professionals. The developing field of regulatory science is designed to address the gap in knowledge between science and research regulations. In essence it is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of all FDA-regulated products. The overall goal of the Master’s program is to provide the skills and knowledge needed to facilitate the evolution of science into healthcare.

The program design will be based heavily on responses received from this survey. The survey consists of 25 questions asking the completer to provide feedback on career goals, curriculum topics, and the program time commitment. Those willing to complete the survey can remain anonymous or, if they are willing to help further, they can sign up to participate in a focus group to discuss the program (they will be given this choice as the last question in the survey). The survey does not retain IP addresses. It retains contact information (name, phone, email) only for those people who sign up for a focus group.
The survey will collect feedback that will be used to design a Master’s of Science program in Regulatory Science. Statistical analysis will be simple and restricted to descriptive statistics and graphical displays.

A paper will be developed for the SoCRA SOURCE regarding the survey and the survey results. The report outline will consist of background and method, highlights and detailed question analysis (gender, age, education, region of US, job title, and employer).

Thank you for your consideration.

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Is there any new development?

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 2010 Salary Survey.

Click Here for the SoCRA 2004 Salary Survey.

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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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