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Mark Your Calendar for the 2016 Charles William Rasco, III Symposium on Colorectal Cancer and GI Malignancies . Physicians, nurses, researchers, pharmacists, social workers and other health care professionals are invited to attend . This professional symposium will review diagnostic and treatment options for various GI malignancies. Presentations will emphasize a multidisciplinary approach for optimal disease management. Registration will be opening soon. Registration is free of charge for this one day conference; CMEs and CEUs are available. Please join me in attendance: 7:30 a.m. – 4:30 p.m. Friday, March 11, 2016 Sam Walton Auditorium Winthrop ...
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I am posting this on behalf of Michelle Purdom, a colleague of mine who is doing her doctoral research on oncology clinical research nurses. Please consider participating if you fit the bill: If you are a nurse who is currently working in a position that is primarily focused on providing direct patient care to oncology clinical trial patients OR that is primarily focused on coordination aspects of oncology clinical trials OR a combination of both, you are eligible for participation in this study. This survey is part of an IRB approved research study to determine the activities performed by oncology nurses whose primary responsibility is direct (example: ...
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The new Apple wearable device is no longer on my "watch" list, and that's because it's now on my wrist! After one week with the Apple Watch, I find myself ramping up my search for news articles discussing health tracking features, along with updates concerning the ResearchKit SDK and the apps already available. And all of this information has got me thinking about where the Apple Watch will fit into the future of clinical research. But before we get to my vision, we need to start with where we are now. All of the entities involved in healthcare are trying to reach the right balance between safety, effectiveness, efficiency, and cost. For the purposes ...
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Boston University is offering three clinical research courses in Summer Term 2 (Jun 30 to Aug 8, 2015). These are evening, undergraduate courses that can be taken separately or folded into a 16- certificate in clinical research. Courses are also offered in fall and spring semesters. Contact the BLCS program if interested or you seek additional information: biomed@bu.edu www.bu.edu/summer/biomedical-clinical
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I know, I know all SAE's should be reported in 24 hours, but I had to say something to get your attention :-). Seriously though! If you have a PI that is a hospitalist (makes rounds at the hospital), and he admits a subject to the hospital (true SAE) on Saturday. Is he required to report the SAE by Sunday if his office doesn't open until Monday morning? Should he carry SAE forms for all studies in his car just in case? This has come up in an audit, and I am not sure how to respond. Thanks for the help! Jennifer
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How can I get started?

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See the original eForum Post
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Smarter Monitoring

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I have been working with a company called Patient Profiles for the last few months, and really wish I had found them earlier. I am really quickly becoming a bigger and bigger fan of the software, particularly as I delve more into Risk-Based Monitoring. So please excuse the shameless plug, but some things are just too good not to share. Last week, I sat in on the ACRP sponsored webinar "FDA/EMA Inspection Lessons: How Adequate Monitoring Can Reduce or Avoid Findings". The main focus was on warning letters received by Investigators, Sponsors (and/or CROs), and IRBs and how better quality monitoring could have mitigated or avoided the warnings all together. ...
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If you have attended any clinical trial conference in the last 2 years, you have heard about Risk Based Monitoring. You have heard people talk about being detectives, looking for trends, and centralized monitoring. But if your experience has been mine, I am always left wondering what tools there are to do this. Having worked on the sponsor side of the industry and managing the Clinical Operations for a small medical device company, I was on my own how to effectively remote monitor a study to be able to manage the monitors time on-site and identify which sites were the highest risk. We reviewed the data in fairly real-time of entry, we engineered tracking ...
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What are the Regulatory requirements for research coordinators to dispense study drug in Canada Can we dispense study medicine to patients in Canada CCRC certificate
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The ObamaCare Affect “A review of the facts” ABSTRACT to the article Prior to the initiation of ObamaCare in October 2013, Health Insurance coverage consisted of most retirees on Medicare or Pension funded Insurance and many employed people covered by private health insurance. Many uninsured and indigent people had the option to apply for Medicaid coverage. Uninsured persons who became ill or injured were responsible for paying all of the health expenses they incurred. Both private and public health care facilities and providers are hurt financially when uninsured patients cannot pay their bills. These losses are eventually passed on to patients ...
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At our site we get paid for an 8 hour day for the days that we travel for meetings as if we were at our daily job. It is not considered PTO and does not deduct from our own PTO balance in any way.
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We have recently opened our new site and would like to invite industry professional to learn more about our capabilities. We are a multi-specialty research practice and have Principal Investigators in several different medical specialties. Our current active specialties include Dermatology, Internal Medicine, Gastroenterology, Orthopedic, Endocrinology and Urology. In addition to these, we have Principal Investigators in the field of Cardiology, Respiratory, Pain Management, Infectious Disease, Gynecology and Allergy . Thursday, September 26 th , 2013 Starting at 7:30 am Cocktails 5:30 pm-7:30 pm ...
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SOP's

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Hello, I am a new site in the Texas area. I am needing help writing SOP's. I have not been in research in a couple of years. Would anyone be so kind to share your SOP's or your template. I would greatly appreciate. Thanks
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I need your help. I need to get my doctoral survey into the hands of investigators. The survey measures current practices by investigators in the management of clinical trial agreements. It contains 30 questions and takes about 10 minutes to complete. I know, contracts aren't an exciting topic but they are an essential part conducting clinical trials and there is very little data to measure the current practices. With the data collected, in addition to completing my Doctorate in Regulatory Science I hope to use the data for change and to create resources for investigators. Please forward the survey link below to investigators you know. https://uscpharmacy.qualtrics.com/SE/?SID=SV_6gulv3OYoI98vD6 ...
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Has anyone ever heard of this or know of existing federal guidance documents that address this?
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At Clinical List America, we make it a priority to stay up-to-date on the latest industry trends, standards and news in clinical research. Because we want to provide our clients with the most innovative patient recruitment for clinical trials , it is important for the Clinical List America team to maintain this industry knowledge. As a part of our initiative to maintain this knowledge, this year Clinical List America attended the Association of Clinical Research Professionals (ACRP) Global Conference and Exhibition in Orlando, F.L. The ACRP Global Conference and Exhibition, which focuses on the conduct of clinical trials and the professional growth ...
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Dear Friends, I need a sample template to collect the investigator details on the basis of speciality.
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Research Staffing

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Does anyone know of a national standard for research coordinator staffing?
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Hi, I would apprecite if you provide accredited,affordable post graduate online courses in clinical research.
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WE NEED ADVICE FOR NEWLY STARTED CRO LIKE MEASURES WHICH HAS TO BE CONCERN,CHECKLIST IF ANY,GRABBING BUSINESS OPPURTUNITIES ETC.
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