%PDF-1.6 %���� 2898 0 obj <>/Filter/FlateDecode/ID[<578E4550E7C14A4482DD46A1F2446567><7115889D802B744DAF1633C080D4DCBE>]/Index[2878 34]/Info 2877 0 R/Length 96/Prev 1029894/Root 2879 0 R/Size 2912/Type/XRef/W[1 2 1]>>stream 2878 0 obj <> endobj Words/SOP in Table 2 gives some indication of level-of-detail, but does not account for economy of expression. ... Clinical Cancer Research eISSN: 1557-3265 All clinical research investigators and staff are subject to review of their clinical research practices by local, regional, and/or federal regulatory authorities as well as sponsors, as appropriate. Title of SOP: Clinical Research Study Files Revision Letter: Rev. ... topic, which vary widely. DGHI is pleased to share these documents with others who are working in resource-limited locations. �{��3l�0^#��]��k�����6����_ �*����,�I�#�F��Dx�Ԥ=�I��h�I�'b�0Y;�NY������p*������`�藱�]X��^X�� � b. Content Check the SOP to make sure it is clear, correct, concise, complete, and comprehensive. Number Name . 1 Research Manual 2 Research Steering Committee Terms of Reference 3 EMS Research Study Review Process Table of Contents. 2911 0 obj <>stream endstream endobj startxref An update on clinical research projects will be presented to the Division, at least twice a year, during the clinical research conferences. Research Standard Operating Procedures (SOPs) were developed, and are maintained and updated as necessary, to provide consistency for designing and managing clinical trials: from initial concept through submission to research committees, recruitment, managing subjects and data, to source documentation and final … Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. Standard Operating Procedures Standard Operating Procedures. The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. Research Briefs: Clinical Trial Brief Report Race-Dependent Differences in Risk, Genomics, and Epstein–Barr Virus Exposure in Monoclonal Gammopathies: Results of SWOG S0120 Madhav V. Dhodapkar , Rachael Sexton , Antje Hoering , Frits Van Rhee , Bart Barlogie and Robert Orlowski 2: Delegation of Responsibility . standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances. Highlights. Quality of essential documents 10 5. Guideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). RA 202 . 0 : i of iv, ii of v, iv of xii), for SOPs that have a table of contents. Florida Atlantic University and Memorial Healthcare System have formed a “Research Partnership to Advance Clinical Trials” (Research PACT), which combines their expertise and resources in clinical research, clinical trials, basic research and translational biomedical research. Selected Articles from This Issue. Documents\SOP Portfolio\SOP Portfolio Source Files \SOP Portfolio.docx) a. Use techniques that condense information, e.g., tables, matrices, bulleted lists, checklists, and diagrams. Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. 4, April 2005 SOMETHING FOR EVERYONE: ... no purchase decision should be made without reviewing an SOP’s table of contents and at least one sample SOP. Study Conduct and Good Clinical Practice . endstream endobj 2879 0 obj <>/Metadata 219 0 R/Outlines 461 0 R/PageLayout/OneColumn/Pages 2864 0 R/StructTreeRoot 499 0 R/Type/Catalog>> endobj 2880 0 obj <>/ExtGState<>/Font<>/XObject<>>>/Rotate 0/StructParents 0/Type/Page>> endobj 2881 0 obj <>stream Introduction . Next-generation Sequencing of Cerebrospinal Fluid: How Can a Liquid be Like a Solid? CCR Translations. Regulatory authorities require that clinical research sites utilize standard operating procedures (SOPs) to ensure that their research is conducted in manner that protects the rights and safety of study subjects and the integrity of the research data collected. Documents to be archived 2 4. TABLE OF CONTENTS Section 1 Definitions and ... Research OCR-ADM-002 •Training on, Availability of, and Interpretation of SOPs •Certificate of Acknowledgment •Research SOP Training Attestation Log: Change of SOP. EHS Operations Management . After changes, remember to update the table of contents so that the page numbers are accurate. Use language and detail appropriate to the staff performing the task. Use short sentences to express a single thought wherever possible. Each section begins with a brief introduction of its purpose and then poses questions to consider to guide content. 7.2.2 The page number of the SOP in “Page X of Y” format for all pages except the table of content pages. 1, No. TABLE OF CONTENTS 1. 4 Purpose The purpose of this SOP is to describe the processes involved in, … SOP Table of Contents SOP Table of Contents – 01-Sep-2012 Page 4 of 4 SOP# version Title Effective Date (dd-Mon-yyyy) Clinical Trials SOPs (201 - 207) 201_01 Labelling and Tracking Biospecimens for Clinical Trials 01-Sep-2012 202_01 Destruction of Human Specimen Material 01-Sep-2012 203_01 Blood Collection for Clinical Trials 01-Sep-2012 RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. DGHI is pleased to share these documents with others who are working in resource-limited locations. Clinical Trial Site SOPs - Contents . Box 90519, Durham, NC 27708, Over 60 SOPs regarding laboratory equipment, supplies, and tests. �rf����b��I���w����x�W�+�N.K��gҮ�V������Vh����:�7�fM�RA���M5V��؈9��f�������X_�iWj+���M%�T8�u7@�����a]���-�0�` ��� ... INTRODUCTION 3 3.1 Scope of the SOP Project and why it was developed 4 3.2 What is Good Clinical Practice (GCP) 4 3.3 How these SOPs fit into an overall structure of a Quality System? Administrative  (Download PDF Bundle - 93KB Zip File), Clinical  (Download PDF Bundle - 1.6MB Zip File), Data Management (Download PDF Bundle - 92KB Zip File), Laboratory (Download PDF Bundle - 2.9MB Zip File), Pharmacy (Download PDF Bundle - 316KB Zip File), DUKE GLOBAL HEALTH INSTITUTE Quality assurance for clinical trials. 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