Category: Study

Professional certification can provide added credentials for those who look for greater career success. The Certified Clinical Research Professional (CCRP) certification from the Society of Clinical Research Associates (SOCRA) is a professional certification for those in the clinical research industry. The ES SOCRA CCRP Exam Study Guide is a comprehensive study guide that may help with preparation for those who plan to take the SOCRA CCRP exam.

Why Do I Need A Study Guide When I Already Got the Reference Manual From SOCRA?

If you have already registered for the SOCRA CCRP exam, you should receive the SOCRA Certification Program Reference Manual in the mail. This manual is a good reference material. But imagine reading through the 21 CFR Parts 11, 50, 56, 312, 812, 45 CFR Part 46, and ICH GCP (E6) from start to finish, it can be quite grueling. By the end of it, how much information will you really get out of it? Also, the SOCRA Certification Program Reference Manual does not contain any industry experience from an industry insider whatsoever. Its just a printout of regulations, thats all it is.

What About SOCRA Clinical Research Professional Certification Preparation and GCP Review Course?

SOCRA offers a 1 day in-person Clinical Research Professional Certification Preparation and GCP Review Course at various locations and dates in the U.S. and Canada. I had attended this course prior to my SOCRA CCRP exam in September 2013. Although the information presented on this course can be beneficial, and I would recommend this to anyone taking the exam, there are limitations to this course:

The cost for this preparation course is quiet considerable ($295 for SOCRA member, $370 for non-member). This is in addition to the cost of SOCRA membership ($75/yr) and the CCRP exam fee ($195).

The course is offered only a hand full of times per year in different locations. If you do not live near the location where the course will be held, traveling is involved. This means more costs for flight, hotel, car rental, and daily expenses.

The information is condensed into compact format in order to fit the 1 day time limit.

The information presented can be found from publicly available sources and is not a substitute to ones own studying.

In my opinion, my own time in studying and taking notes from publicly available relevant information (various GCP trainings, CFR, ICHs GCP, industry websites, etc.) and years of industry experience helped me much more. Another reason is that it was impossible for me to retain information from a 1 day compact course. It was useful for me to summarize key information from my own studying and absorb them at my own pace. If I were to attend this 1 day course without spending the time to study on my own prior to the exam, I would not have aced this exam or even passing it.

How ES SOCRA CCRP Study Guide Can Help Save You Time and Sanity

Instead of trying to plow through countless FDA regulations, guidelines, and industry practices, imagine if there is a Study Guide that helps summarize all those materials in an easy to digest format in bullet points. Imagine if you can click and search different topics in seconds. Imagine if you can browse through and learn the information at your own place in the comfort of your home. Imagine if there are tips and suggestions from someone in the industry who had gone through the exam and aced it with flying colors.
Imagine no more

Imagine no more. I have compiled the note I took when I was studying for the SOCRA CCRP exam in September 2013. I have named it ES SOCRA CCRP Study Guide (ES stands for Ernie Sakchalathorn). From these notes, I was able to pass the SOCRA CCRP exam with a score of 96% (I answered 130 questions correctly out of 135 questions total, click HERE to see my score letter). Inside this Study Guide, there are:

100+ Pages of Complete and Outlined Summaries of Materials for the SOCRA CCRP Exam

Sidebar Navigation Menu with Clickable & Expandable Links to Any Section

A Complete Bullet Outline of The Entire SOCRA CCRP Certification Process

Personal Tips From My Industry Experience Both As a CRC And a CRA

Updated to apply to new exam outline for exams to be held after June 1, 2014

For todays education system, which has vast syllabus and excess competition, proper study skills have become a major requirement. Only then can one achieve good results. Every student has a different way of learning and working which can be optimized only with an effective study skill. On comparing two students what we get to know is that one student has the ability to grasp the significance of good study skills. But the other is confused as he doesnt know from where to start. This becomes the reason for the difference in their results.
There are certain things that we need to correct first before
improving study skills of the students. This includes the sources of distraction that divert their minds. It is very much in our notice today that the new technologies and advancement of gadgets have taken the first position in the lives of students. The best example of this is cell phones and iPods. These gadgets serve as the perfect way to turn away the minds of the students from their obligation of studies.
Teachers complain that the study habits of the students are not good and effective enough. This is very much clear from the results of the first test of the school year. Every parent has a wish for their son/daughter to earn an A+ in every class. But have they ever tried out an effective study planning for their child? Here are certain study skills tips that can help a child improve his grades:
1. While reading a particular text book, write notes about important points for proper understanding. Go through the notes everyday as this will help you to keep the topic fresh in mind.

2. Create study skill activities to be used on weekly basis. For example have a weekly session where you write down important facts that you have learnt that week, using your memory alone.
3. Give some extra time to thee subject you are weak at and dont miss out testing your self every week on that subject particularly.
4. Dont allow test anxiety to crawl into your emotions. Reduce it by spending more time preparing for each of your tests. At least keep five days of preparation time for these tests.

5. There is one very big problem with the students and that is of being reluctant to ask questions from teachers when they dont understand any topic. You should keep in mind that approaching the teacher will give you even a better understanding of the topic. Dont feel shy to do so.
7. Write down notes on important facts so that you can review them the morning of your test. If you are involved in a math or science course write out all of the important formulas on one sheet of paper and review these formulas the morning of your next test.
Following these tips and a habit of regular studies place you among the rank holders of your class and also you will be stress free during your exam days.

INTRODUCTION

In recent years, breast cancer awareness has grown considerably but the disease itself remains deadly and is the second leading cause of cancer related deaths among women in the US. Approximately 30% of breast cancer diagnoses, particularly the more aggressive cases, are characterized by overexpression of human epidermal growth factor receptor 2 (HER2). HER2 is one of a family of four HER cell surface tyrosine kinase receptors, which is also know as Neu, erbB-2, CD40, and p-185. Unlike the other HER family members, HER2 does not bind any known ligands but rather remains constitutively in a conformation that favors dimerization with other HER receptors.

HER dimers that include HER2 are more potent activators of their downstream signaling cascades, which favor cell proliferation and differentiation. In breast cancers, overexpression of HER2 correlates with a poor prognosis and shorter disease free survival. For these reasons, the search for breast cancer treatments has focused largely on identifying inhibitors of HER2 activity.

MECHANISM OF HER2 INHIBITION

The first drug to be developed for inhibition of HER2 was Herceptin (transtuzumab), which was a monoclonal antibody that binds the extracellular domain of HER2 to inhibit dimerization. Herceptin remains the first line treatment for HER2 positive breast cancers.

Afatinib and Lapatinib are the second generation HER2 inhibitors that are commonly used to treat cases that have progressed after initial treatment with herceptin. Both afatinib and lapatinib are tyrosine kinase inhibitors that block the downstream signaling of HER2.

A new second generation drug, Neratinib, is currently in clinical trials where it is demonstrating better results than either of its predecessors.

NERATINIB

In 2009, the first results of an ongoing Phase I/II trail studying the efficacy of Neratinib in breast cancer were reported. This study showed that neratinib in combination with a pre-existing therapeutic had an overall response rate of 69%.

A second report from a Phase II clinical trial was published in the Journal of Clinical Oncology in 2010. The study enrolled 136 patients with stage III or IV, HER2 positive, breast cancer. Approximately half of the patients enrolled had received previous herceptin treatment. In this study, neratinib was used as a stand alone therapeutic. The results showed that 16-week progression-free survival was 59% among women who had previously been treated with herceptin and 78% among women with no prior treatment. Furthermore, 24% of women who had previously been treated with herceptin responded to the therapy as did 56% of women who had had no previous treatment. The conclusions of this study stated that neratinib is an active and reasonably well tolerated therapeutic for advanced, HER2 positive breast cancer. Because of these favorable outcomes, neratinb proceeded to Phase III trials.

I-SPY2 STUDY

In March, 2010 a study called Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis, or I-SPY2, launched as a collaboration between three pharmaceutical companies, the FDA, the National Institute of Health (NIH), and non-profit groups. The goal of I-SPY2 is to use DNA to match one of five drugs to each individual patient for the best outcome. The study is expected to last five years and cost $26 million.

Neratinib is one of the drugs being studied in I-SPY2, along with veliparib (a PARP inhibitor), conatumumab, AMG386, and figitumumab (a IGFR inhibitor). Patients at 20 cancer centers will have DNA testing done on their biopsy specimens and will be treated with one of the drugs pre-surgery to determine if the drug used can prevent progression of the tumor.

SUMMARY

The I-SPY2 study is the first of its kind in that the FDA has granted approval for up to 12 different drugs to be tested without having to halt the trial and write a new protocol. The hope is that level of deregulation will make the trial more efficient and allow it to have faster and greater impacts on a number of diseases. It is the first study to combine the study of biomarkers and therapeutics in order ot forge a path to personalized medicine.

REFERENCES

1. Burstein HJ, Sun Y, Dirix LY et al. Neratinib, an irreversible ErbB Receptor tyrosine kinase inhibitor, in patients with advanced ErbB2-positive breast cancer. Journal of Clinical Oncology. 2010; 28: 1301-1307.
2. Rabindran SK, Discafani CM, Rosfjord EC, et al. (June 2004). Antitumor activity of HKI-272, an orally active, irreversible inhibitor of the HER-2 tyrosine kinase. Cancer Res. 64 (11): 395865.
3. Minami Y, Shimamura T, Shah K, et al. (July 2007). The major lung cancer-derived mutants of ERBB2 are oncogenic and are associated with sensitivity to the irreversible EGFR/ERBB2 inhibitor HKI-272. Oncogene 26 (34): 50237.
4. Mnard S, Tagliabue E, Campiglio M, Pupa SM. Role of HER2 gene overexpression in breast carcinoma. J Cell Physiol. 2000;182:150-162.
5. Seshadri R, Firgaira FA, Horsfall DJ, et al. Clinical significance of HER-2/neu oncogene amplification in primary breast cancer. The South Australian Breast Cancer Study Group. J Clin Oncol. 1993;11:1936-1942.
6. Baselga J. A new anti-ErbB2 strategy in the treatment of cancer: prevention of ligand-dependent ErbB2 receptor heterodimerization. Cancer Cell. 2002;2:93-94.
7. Tsou HR, Overbeek-Klumpers EG, Hallett WA, et al. Optimization of 6,7-disubstituted-4-(arylamino)quinoline-3-carbonitriles as orally active, irreversible inhibitors of human epidermal growth factor receptor-2 kinase activity. J Med Chem. 2005 Feb 24;48(4):1107-31.

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Books that are prescribed by Central Board of Secondary Education for students studying under this board are referred to as CBSE books. To perform well in CBSE examinations or for that matter any other school exam, it is very important for students to thoroughly go through the CBSE books. The questions asked in the final CBSE examinations are either directly picked from the end-of-chapter exercises in these books or are based on the NCERT questions with minor modifications. To score top marks and gain the maximum from the learning activity, it is essential for students to prepare quality notes from the CBSE books.

Students can follow this simple five-step process to learn how to prepare quality notes from CBSE books. These steps will help students approach their studies and related activities in the correct manner and will also enable them to score great marks in the final examinations; thereby making their learning activity a thoroughly enriching one.

The first and foremost step is to thoroughly go through the entire chapter in the CBSE book. This will acquaint students with the concepts, processes and other important information in the chapter. It will also help students to obtain a fair idea of the efforts required to proficiently complete the chapter and related topics.

After going through the chapter, the next step is to then assess knowledge levels with respect to understanding of key concepts, retention of important information etc. Such an assessment at this level will enable students to work efficiently towards completing their syllabus within the stipulated time period. It will also ensure that students do undertake other important activities related to studies.

After making an assessment of the knowledge levels, comes the time to prepare notes from the CBSE books. While preparing notes from the CBSE books, students should make sure that they are reproducing word-by-word from it. Ideally, such notes should be based on students understanding of concepts. Students should first try to understand the concepts in CBSE books then prepare a list of all important concepts and finally prepare notes for all these concepts in their own language. While preparing such notes students should keep the following points in mind.

-Students should try to keep these notes crisp and to-the-point. It will not only promote effective understanding but will also be useful for quick revision.
-While making notes from CBSE books students should make sure that they are as per their learning styles. Notes according to the preferred learning style will help students learn and process information quickly and efficiently.
-Students should try to support their notes with value-adding illustrations and videos. It will promote comprehensive learning and will also help students score extra marks in exams.

Once through with preparing notes from CBSE books, students should try to solve questions available in end-of-chapter exercises. A practice session like this will help students identify their knowledge gaps, clear all their doubts and fill those gaps to solidify learning.

Students can also seek help from a variety of websites that provide CBSE-aligned learning and assessment solutions. The learning solutions by such websites include free NCERT solutions, study material, formative assessments, interactive puzzles, tests, revision notes etc. Referring to such content can make learning a thoroughly enriching experience.

All the best!

Work on your Anki every day along with your anime watching. You’ll learn a great deal of language and you’ll find you very often remember the circumstance in which you first noticed it. This can be a significant aspect of studying Japanese through anime as it offers you a good knowledge of how a term is obviously used, and will even make it easier to recall. As you continue learning Japanese via anime you will experience exactly the same word again in different contexts. This may improve your understanding of the words range of meaning and inference and also make it increasingly easy to remember.
The causes for seeking learn other languages are various and understanding Japanese is not any exception. One of many key causes of learning this language is unique and engaging. Once you have made a decision to study a new language then it’s necessary to find a very good means of mastering it. You can find plenty of various ways to learn a new language. Among several through the use of internet is one of the very best ways to learn Japanese. In your home of web you may find several bedrooms of sites that may give you a best company to help understanding Japanese.
When learning a fresh language, its nearly impossible not to acquire an understanding of the culture that created it. The structural attributes in Japanese, like honorific verbs and unique kinship terms provide insight to their culture. As you digest more Japanese media, you’ll broaden your understanding of not just the language, but the lifestyle this language shows. This opens the mind to variations in society, and enables you to also reflect on the societal norms contained in your personal country. Businesses seek staff which are able to empathise with distinct cultures, and who can perhaps work efficiently in a interconnected world. 3. Its enjoyment.
Understanding how to interact with people may be complicated, its tough to understand this out of your notebook in your bedroom. You need to be out, speaking with anyone you can. From the ticket seller at the stop for the person where you purchase your morning caffeine, know about your surroundings, and take clues on how best to act from those around you. Follow the exemplory case of others in how they greet people. Or how they bow to the people they are speaking with. Backup their illustrations, but guarantee you are burning somebody who is of the somewhat same age and gender as you.
Welcome to Understand Japanese Pod, a podcast, website and community for people who desire to study Japanese the fun and easy way. The podcast is hosted by Asuka and Alex who educate you on useful Japanese phrases and vocabulary to greatly help with daily discussions and connection. Whether you are an anime or manga lover, students of Japanese or planning to visit Japan, this podcast and website is right for you. Click-Here for useful articles for howto study Japanese. ???? ??? ?? (Learn Japanese Pod) ???? ???? ?? ??? ??? ??? ?? ????, ???? ??? ????? Learn Japanese Pod? ?? ?? ?????.
All About Particles is a superb lightweight book which explains those devilish particles that american individuals of Japanese locate rather complicated to perfect. I like the instances, the facts and ofcourse the dimension. It doesnt waffle and is to the idea with the essential information you need for both spoken or written Japanese. Take a look. Another excellent book from the same creator, Naoko Chino, is A Dictionary of Basic Japanese Sentence Patterns (Kodansha Dictionary) that will be worth a look. I ought to mention two common points about learning contaminants in Japanese. 1) Make sure to not get too bogged down with particles. 10) Pratical Business Japanese.