Guide for Investigator Initiated Trials

Guide for Investigator Initiated Trials PDF Author: G. Fortwengel
Publisher: Karger Medical and Scientific Publishers
ISBN: 3805596855
Category : Medical
Languages : en
Pages : 189

Book Description
For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the ‘International Conference on Harmonization and Good Clinical Practice’. This makes the publication at hand an essential ‘cookbook’ for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.

Madame Blavatsky on the Trials and Triumph of Initiation

Madame Blavatsky on the Trials and Triumph of Initiation PDF Author: Helena Petrovna Blavatsky
Publisher: Philaletheians UK
ISBN:
Category : Religion
Languages : en
Pages : 66

Book Description
1. The Origin of the Mysteries. The last incarnation of one of seven “Lords of the Flame” was Baladeva, Krishna’s brother. Hercules is none other than Baladeva in Greek dress. In the Golden Age, Esoteric Knowledge was common property. Initiation arose later on from the necessity to limit the number of those who knew. The Initiate’s maxim was “All for the people and with the people.” The old Initiates were real philosophers, priests, and healers. They commemorated the secrets of their Mysteries in hieroglyphics. Only those, whose purity allowed them to look at the great Isis unveiled, were admitted to the secrets of Nature and Man. But what Gods and Angels had revealed, Moses reveiled and hid from the sight of the world. 2. The Trial of the Sun-Initiate. Vishvakarman (Hierophant or Logos Demiourgos) cut off seven locks of the neophyte’s long hair (Second Sun’s rays) and replaced them with a crown of brambles — thus making him Vikartana, “shorn of his rays.” The neophyte who can overcome the dreadful trials of Initiation (on the cross of his worldly passions) dies in the Chrestos condition (freed from the clutches of matter) before his second and triumphant birth in Spirit as Christos. The Masonic rite of Initiation is based upon the construction of the Temple of Solomon, a narrative modelled upon Egyptian and still earlier symbolisms. Yet, there never was an Occult Society, however open and sincere, that has not felt the hand of the Jesuit trying to pull it down by every secret means. The Jesuits infected mankind with passivity, ignorance, and superstition in order to impose their Universal Despotism unopposed. 3. The Mystery of the “Sun of Initiation.” In the days of Aristotle, few were the true Adepts left in Europe and even in Egypt. Solus-Sol-Sun is “The One” and the Greek name for Helios, the Most High. But there is a great difference between our Sun and its prototype, the Central Spiritual Sun. 4. The Objects of the Mysteries. Whether lesser or greater, Mysteries have always been graded. Theophany is the appearance of God to man; Theopathy, man’s assimilation of his divine nature; Theopneusty, inspiration or rather the power to hear the Voice of God. The last two are experienced when the neophyte passes through the crucifixion of flesh or matter. The Grecian Mysteries were identical with the Initiations of Buddhist and Hindu Adepts. In India, the candidate of the third degree of Initiation has two Gurus. But whether Eastern or Western, the Initiate dares all and keeps silent. Masonic Initiation was modelled on that of the Lesser Mysteries and remains an authority upon the three fundamental degrees. The triple duty of a Mason is to study whence he comes, what he is, and whither he goes. 5. Traces of the Mysteries. The Round Towers in Ireland and Asia were connected with the Vishvakarman and Vikartana rites. In later ages, the Initiates of the Left Path and the anthropomorphists turned them into phallic monuments. The key to the mystery of Initiation (and to the real Christ, not the blasphemous caricature of the Churches) lies on the difference between the terms Chrestos and Christos. There were two Messiahs, Chrest and Christ. Jesus was an Initiate of the Egyptian Mysteries, where the rite of the suffering Chrestos on his trial, and second birth as Christos (by regeneration), were enacted. It was on the seventh day, the third of his ultimate trial, that the Eastern neophyte arose as a regenerated man and returned to earth as triumphant conqueror of death, a Hierophant. Initiates are said to have “crushed the serpent’s head,” i.e., conquered their sensual nature. The Egyptian Initiates held the Rose as symbol of Nature, the mother and nourisher of man, represented as a virgin woman. The Brothers of the Rosy Cross, as a symbol of sexual procreation. The old Indian Mysteries of Initiation were brought to Greece by Orpheus, nine millennia before Homer and Hesiod. 6. The Last of the Mysteries in Europe. Alesia, Arles, and Bibractis, the last bastions of the Ancient Mysteries in Europe, are no more. Occult Wisdom is now replaced by absolute theocracy that displays its crowned priests to the ignorant masses. Whatever else Cheops might have done, he has not built the pyramid bearing his name. Neither Solomon his temple, nor Noah his arc, for that matter. The strict silence of the Initiates and the total loss of all written memorials of secret knowledge may explain why so little is known of the Ancient Mysteries. Yet, there is spiritual Alchemy and physical transmutation: their cradle is to be sought in the most distant times. 7. The Post-Christian Successors to the Mysteries. The Neo-Platonic School of Ammonius Saccas became the successor of the Eleusinian Mysteries and herald of the Eastern Secret Teachings — unveiling the long and laborious descent and re-ascent of the Divine Monad or Soul. Each of us have to pass through the “Valley of Thorns” before he emerges into the plains of divine light and rest. The Eclectic doctrines are strongly reflected in the Epistles of Paul and John the Evangelist. For it is not Judaism and Christianity that remodelled the ancient Pagan Wisdom, but rather the latter that put its heathen curb on the new “faith” and was further influenced by the Eclectic Theosophical system, the direct emanation of the Wisdom-Religion. Ammonius, Plotinus, Iamblichus, Proclus, were prominent Theosophists though they never claimed the title. All that is grand and noble in Christian theology comes from Neo-Platonism. Ammonius was a true Philaletheian, one of us. His Eclectic Theosophical School, a precursor and prototype of the modern Theosophical Movement, was made of the crumbs permitted to be gathered from the antediluvian lore. Woe to those who mock Divine Knowledge and betray her secrets. But those who are pure in thought and deed, and have trust and confidence in their immortal spirit, have nothing to fear.

Teaching and Behavior Support for Children and Adults with Autism Spectrum Disorder

Teaching and Behavior Support for Children and Adults with Autism Spectrum Disorder PDF Author: James K. Luiselli
Publisher: OUP USA
ISBN: 0199736405
Category : Medical
Languages : en
Pages : 239

Book Description
This guide is an indispensible asset, appropriate for any behavioral specialist, on all aspects of this increasingly prevalent disorder. Teaching and Behavior Support for Children and Adults with Autism Spectrum Disorder brings together contributed chapters on assessment, instruction, and behavioral intervention procedures unique to the autism population.

Clinical Trial Project Management

Clinical Trial Project Management PDF Author: Ashok Kumar Peepliwal
Publisher: Elsevier
ISBN: 0443136289
Category : Business & Economics
Languages : en
Pages : 352

Book Description
Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. Covers how to conduct clinical trials in detail Present useful, basic, and advanced statistical tools Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book

Oncology Clinical Trials

Oncology Clinical Trials PDF Author: William Kevin Kelly, DO
Publisher: Springer Publishing Company
ISBN: 0826168736
Category : Medical
Languages : en
Pages : 568

Book Description
The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials. Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology. NEW TO THIS EDITION: Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more Comprehensively covers all regulatory aspects in the pursuit of global oncology trials Digital access to the ebook included

Companion Guide to Measurement and Evaluation for Kinesiology

Companion Guide to Measurement and Evaluation for Kinesiology PDF Author: David Tomchuk
Publisher: Jones & Bartlett Learning
ISBN: 0763776106
Category : Family & Relationships
Languages : en
Pages : 256

Book Description
This practical guide is perfect for use in conjunction with a measurement and evaluation text or as a standalone quick-reference for athletic trainers, coaches, strength and conditioning professionals, personal trainers, fitness professionals, and physical education teachers. --Book Jacket.

Report

Report PDF Author:
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 904

Book Description

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