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Discussion Board: Comments & Questions

Anonymous wrote (2nd Sep, 2010) I saw a notice for FDA Clinical Investigator Training Course, has anyone does this, what were your thoughts on it?	delete reply
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Anonymous wrote (2nd Sep, 2010)

Thankfully I haven't had to deal with this (yet) in my research career, but I am sure it will come one day and this was a great read ""What to tell patients when a trial goes awry" http://www.nytimes.com/2010/08/24/health/24alzheimers. html

Anonymous wrote (9th Aug, 2010) Fascinating new work by Duke University on the presence of learning curves within a clinical trial - building on the work that's been done in clinical care. Shows protocol violations and data queries to be skewed towards the earlier days of the study.	delete reply
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Anonymous wrote (19th Jul, 2010)

A survey of 590 clinicians and medical students, attitudes toward industry and gifts were generally positive; 72.2 percent of participants found sponsored lunches appropriate. "Notably, many participants 74.6 percent found large gifts unacceptable and, like participants in previous surveys, believed that other physicians were more likely to be influenced by gifts and food from industry than they were," the authors write.

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Anonymous wrote (19th Jul, 2010) Has there been much discussion at your institution about the proposed changes to NIH conflict of interest discloscure requirements?	delete reply
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Anonymous wrote (30th Jun, 2010) Does the PI personally have to obtain informed consent?	delete reply
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Anonymous wrote (9th Jun, 2010)

FDA has issued revised information sheet guidance on "Clinical Investigator Administrative Actions - Disqualification." This document replaces a previous information sheet titled "Clinical Investigator Regulatory Sanctions." The revised document is now available from FDA's website using the following web link: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ UCM214008.pdf.

Anonymous wrote (9th Jun, 2010)

FDA has issued final information sheet guidance on "Frequently Asked Questions - statement of Investigator (Form FDA1572)." The document is now available from FDA's website using the following web link: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ UCM214282.pdf.

Anonymous wrote (7th Jun, 2010)

All of my experience in clinical research has been through pharmaceutical conpanies; one of the physicians in our group is interested in cancer prevention with an academic institute running all the tissue analysis. It is much more in the realm of government funded research. Does anyone know of a consultant or a consulting company that specializes in this area of research; including applying for or writing grants, etc. We are in the Southeast.

Anonymous wrote (29th May, 2010)

Has anyone got advice on applying for Small Business Innovative Research grants? We have a proposal that we think might fit but no experience applying.

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