News from the Office of Research Compliance
- Modifications to the Application for Expedited or Full Committee Review (and the Five Year Application as well)
- What content needs to be included in the protocol for an investigator-initiated study?
- Does your research impact departments other than your own?
- Are you involved in research that is conducted internationally?
- Would you like to schedule an in-person meeting with a member of the ORC Staff?
News from the Food and Drug Administration
- FAQ's and Guidance Document on the FDA Form 1572 (Statement
News from the Office of Research Compliance
1. Modifications to the Application for Expedited or Full Committee Review (and the Five Year Application as well)
Section XI.8 (Special Topics: ICH-Good Clinical Practice Guidelines) (Modified): For our biomedical investigators: In accordance with AAHRPP recommendations, we are clarifying that compliance with FDA's ICH-GCP guidance is expected only when the funding entity (usually Industry, conducting international research) requires it.You will know if your protocol must comply via specific reference in the sponsor's protocol and/or in the protocol's investigator signature page. If your study must be conducted in compliance with these guidelines, you will need to complete Section XI.8 of the application. Your responsibilities relating to ICH-GCP are outlined in Sections 4.1-4.13 of FDA's guidance,
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129515.pdf As confirmation that you are aware of your responsibilities as an investigator conducting a study in compliance with ICH-GCP, you will also need to complete the new Supplemental Form D (available in the IRBNet Designer Library) and upload it into your IRBNet package when applying for approval.
Section XI.9 (Special Topics: Does your study involve investigational devices)(New): In response to comments made by our AAHRPP site visitors, we needed to gather additional information to review above and beyond what is captured in the registration document. Section XI.9 now asks if your study involves the use of investigational devices, and if it does, you need to provide information concerning where the device(s) will be stored, the security of the storage unit/facility, and how the dispensing of the device(s) will be controlled and documented.
2. What content needs to be included in the protocol for an investigator-initiated study?
The IRBNet Designer Library now contains a document ('Protocol Template for Investigator-Initiated Studies') that provides guidance on sections you should include to ensure a complete study protocol.
3. Does your research impact departments other than your own?
Are you using their facilities or patient populations? Do you list co-investigators from other departments? If yes to any of those questions, you must obtain approval from the chairs of those departments (by sharing your project with them in IRBNet, and obtaining their e-signature as endorsement). By having all impacted parties in the know, you will help ensure the smooth conduct of your study.
4. Are you involved in research that is conducted internationally?
You might be interested in reviewing the powerpoint presentation from the March 2010 AAHRPP Webinar on the topic of human subject protections in transnational (international) sites. It provides an interesting perspective on providing such protections when faced with unique challenges, cultural norms, and local laws that factor into play when dealing with international populations. You can access the PPT here: http://www.stonybrook.edu/research/orc/docs/AAHRPP-International-Research-Webinar-Handout.pdf
5. Would you like to schedule an in-person meeting with a member of the ORC Staff?
We would be happy to accommodate your request. Since our office is currently undergoing renovation for a period of approximately two months, please e-mail the staff member with whom you'd like to meet, or call 631-632-9036 to leave a message, to schedule a convenient time and place to meet. If you need to drop off paperwork, you may do so in our temporary location in Melville Library, 5th Floor, Suite S5421
News from the FDA
The Food and Drug Administration has finalized a 2008 Frequently Asked Questions guidance document and information sheet related to FDA Form 1572, "Statement of Investigator." According to one FDA expert, the guidance contains "significant changes" from the 2008 version, including requiring study coordinators to be listed on the 1572, which means they must file financial disclosure information.
Link to guidance: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf
Any questions, comments, etc, please feel free to contact me.
Judy Matuk, M.S.
Assistant Vice President
for Research Compliance
Office of Research Compliance
Stony Brook University
Stony Brook, NY 11794-3368