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 Dalhousie University Division of EMS (Department of Emergency Medicine) SOP TABLE OF CONTENTS . h��XYo�8�+|lRއ�€�z`�U�-�A�UGXE6,u�����HFv���.��Ø��\�~6,\�FD��#� ���k�H"�EF�%2�p�r�p'r��y}G��}eDI'��(_����3��������cE���;8x�,�˪Y{>��֋( *s��n4��u����W�A)�X�>���*�T������.��t:)�rI��$j\�ʄ����iN>u[��}���5�� ����p����p��I��R���h�զ���������wEW�E��֛�n4B���l:�3tZl^���#�:+��)4��Ū����N&믗'�hF�.��+:/n����x[�s/ySܔ���.� �e����A��>�b��vE]-�ͪ. h޼��KSQǟ�vww�S��#Dԥ+�̌�R�P��3&z鎒A�F�a/�J#Dm���]�S��*[ƨQf�0&��$�7���k���9��x8 ��mH �����-���#�‹Lj���V�Wg3��?7�T_���v�&Nolܢ�3�Ha_���;�q2I���/�t����+���]z����9�WB2��v�e�6���fڌ����u�$�3z�{�s��W����H���?�K���NV�:Z܎�x|x����uV�\����2;����|!ȝq�:�fo�\�a�n������S�-�B����2Mn��u� �zU�'4��zC�mȆT��Z�l8��jY�Z����ŎtH���aI��`�r�:+I��أ����'����Û�{zV�-�Ѵ����z�*��J'�q��\E���+$j�D�� "�x,�""���D���8�fA��mT�U#ެ,j�W2 O*� B@Z�*L�`G �yW��E��/���ض�t�-���{E�W͸i���W۶�^[��-���EPZ��˧3���TR>�{�]��V3�3IX�IjM�6��ˈ1�pxRʞ@���ua���c���G"�sƵ�d������,��¼��' x]�{�����)�|�c�p�1 y?���o�M$)���_� R��p�����$�"m���k4GJ� After changes, remember to update the table of contents so that the page numbers are accurate. The NIMH Clinical Research Toolbox serves as an information repository for NIMH staff and the clinical research community, ... (SOP) template to document how investigational product (IP) will be received, ... Back to Table of Contents. Documents\SOP Portfolio\SOP Portfolio Source Files \SOP Portfolio.docx) a. 0 The Campbell Foundation's SOPs help define the clinical research group’s standard h�bbd``b`�$� �@�EH03��f �� ��X_A�'��� $B7�$�W4�`T�6 % .7��Ob`b�>�������}_ ǼF 1, No. 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. 1 Purpose 1 2 Scope 1 3 Review of clinical trial protocol 1 4 Rights and responsibilities of participant 10 CCR Translations. Study Conduct and Good Clinical Practice . SOP Table of Contents Page 1 of 2 Updated May 15, 2017 SOP# version Title Effective Date (dd-Mon-yyyy) N2 SOPs (001 – 019, 023 - 025) 001_08 Standard Operating Procedure (SOP) Administrative Management by Network of Networks 15-May-2019 002_08 Research Team Roles and Responsibilities 15-May-2019 003_08 Research Team Training 15-May-2019 Selected Articles from This Issue. Media to be used 10 6. 3: Process for Obtaining Informed Consent . Content Check the SOP to make sure it is clear, correct, concise, complete, and comprehensive. Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. Introduction 2 2. Clinical trial agreement log. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc...) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidance. SOP QA5 Fraud and Misconduct . SOP S3 Staff Responsibilities, Duties and Job Descriptions . Highlights. DGHI is pleased to share these documents with others who are working in resource-limited locations. RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. SOP TOC – titles only EMS Research Standard Operating Procedures (SOPs) Emergency Health Services . 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 7.2.2 The page number of the SOP in “Page X of Y” format for all pages except the table of content pages. Table of Contents. A Effective Date: 01 Jan 2012 Step Seven: Have the SOP reviewed, signed, and dated by a member of the research department that has the ability to approve SOPs (this will generally be a research direc- Use short sentences to express a single thought wherever possible. SOP-QA-24* V3: Managing a Change in Chief Investigator of a CTIMP or Medical Device Clinical Investigation - SOP-QA-1* V4: Managements of SOPs . (919) 681-7760globalhealth.duke.edu Regulatory and Study File Content Template . ... topic, which vary widely. ... SOP S1 Description of Organization Structure . Clinical Research Protocol Feasibility and Site Selection ; 15-May-2015 : 005_06 ; Study Initiation/Activation : 15-May-2015 : 006_06 : Informed ; Consent Forms : 15-May-2015 : 007_06 : Research Ethics Board: Submissions and Ongoing ... SOP Table of Contents Author: Office of Research … RA 202 . Use techniques that condense information, e.g., tables, matrices, bulleted lists, checklists, and diagrams. ... 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? Standard Operating Procedures Standard Operating Procedures. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) Guideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). 1 Table of Contents ... European Union Clinical Trial Directive1, ICH Good Clinical Practice ... distinguish between regulations for Clinical Trials of a Medicinal Products (CTIMPs) and for other research. Next-generation Sequencing of Cerebrospinal Fluid: How Can a Liquid be Like a Solid? 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 endstream endobj startxref Scope 2 3. Clin Cancer Res December 1 2020 26 (23) 6075-6075; CCR Translations. SOP S2 Staff CV . The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. Documents to be archived 2 4. Highlights. Table of Contents . 5 ... Clinical research sites may also be involved in … 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 RA 201-B: Table of ICH Essential Documents . 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. 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