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"All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals."

"The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically–relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up. Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. Confidently apply gold standard treatment for 10 of the most critical areas of cardiology Written by an international team of experts, Cardiovascular clinical trials : putting the evidence into practice, provides a succinct overview of recent major clinical trials, the gold standard for all medical treatment, across all the major cardiovascular subspecialties, to ensure you’re up–to–date on the most critical findings Guides cardiology trainees and clinicians on how cardiovascular clinical trials are designed and conducted, including statistical methodology."

"Penelitian ini menguji keberadaan anomali akrual pada perusahaan yang terdaftar di Bursa Efek Indonesia pada tahun 2009, pengaruh kualitas audit terhadap anomali akrual tersebut, serta pengaruh strategi trading yang memanfaatkan keberadaan anomali akrual. Kualitas audit diukur dengan ukuran Kantor Akuntan Publik (Big-4 dan Non Big-4). Sedangkan anomali akrual diukur dengan besarnya abnormal returns yang terjadi, seperti dalam penelitian Sloan (1996). Hasil penelitian ini menunjukkan bahwa anomali akrual memang terjadi di Indonesia, dengan bentuk yang berlawanan dengan yang pada umumnya terjadi di luar negeri (overweighting akrual), yakni underweighting akrual. Dalam penelitian ini juga terbukti bahwa kualitas audit berpengaruh terhadap anomali akrual yang terjadi tersebut. Selanjutnya, ditemukan juga bahwa anomali akrual tersebut dapat memberikan keuntungan melalui strategi trading tertentu.

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This study examines the existence of accrual anomaly in companies listed in Indonesian Stock Exchange 2009, the effect of audit quality on the anomaly, and the effect of trading strategy that exploit the existence of the anomaly. Audit quality was measured by size of auditor (Big-4 or Non Big-4). Accrual anomaly was measured by magnitude of abnormal returns formed. It was found that the accrual anomaly does occur in Indonesia, but with a form contrary to that generally occur in foreign countries (overweighting accrual), which is underweighting accrual. In this study also shown that the quality of audits will affect the occured accrual anomaly, but only in companies that receive lowquality audits. Furthermore, it was also found that the accrual anomaly can provide benefits through a particular trading strategy."

"This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals.The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives."

"This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials."

"Penelitian ini membahas mengenai pengaruh Pendidikan Profesional Berkelanjutan PPL dan Audit Capacity Stress ACS terhadap kualitas audit. Penelitian ini adalah penelitian kuantitatif menggunakan analisis regresi logistik binomial dengan SPSS 20. Hasil penelitian menunjukkan bahwa PPL berpengaruh positif terhadap kualitas audit dengan 3 pengukuran ukuran Kantor Akuntan Publik KAP yang berbeda yaitu KAP Big 4, KAP Big 20, dan KAP yang bekerjasama dengan Kantor Akuntan Publik Asing KAPA / Organisasi Audit Asing OAA . Audit Capacity Stress berpengaruh negatif terhadap kualitas audit dengan pengukuran KAP Big 20 dan KAP yang bekerjasama dengan KAPA/OAA. Sedangkan untuk ukuran KAP Big 4, audit capacity stress ditemukan tidak memiliki hubungan terhadap kualitas audit. Implikasi dari penelitian ini bahwa regulator perlu membatasi jumlah klien yang ditangani oleh Akuntan Publik per tahunnya agar kualitas audit dapat tetap terjaga.

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This study investigates the influence of Continuing Professional Education CPE and Audit Capacity Stress ACS on Audit Quality. This study uses binomial logistic regression using SPSS 20 software. The results show that CPE has positive significant influence to audit quality in three different measurements with regards to the size of Public Accounting Firms that are Big 4 Accounting Firms, Big 20 Accounting Firms and International Accounting Firm Affiliations. Audit Capacity Stress is found to have significant negative influence in Big 20 Accounting Firms and International Accounting Firm Affiliations. While in Big 4 Accounting Firms, Audit Capacity Stress is found to have no impact on audit quality. Implication from this study is that there should be regulations regarding the maximum number of clients per Public Accountant per year in order to mantain audit quality."