clinical research sop table of contents

... SOP S1 Description of Organization Structure . 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. 1: JHM Training/Certification Documentation . 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- Dalhousie University Division of EMS (Department of Emergency Medicine) SOP TABLE OF CONTENTS . RA 202 . SOP. ... 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? 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 Quality of essential documents 10 5. Documents\SOP Portfolio\SOP Portfolio Source Files \SOP Portfolio.docx) a. 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. Words/SOP in Table 2 gives some indication of level-of-detail, but does not account for economy of expression. 2878 0 obj <> endobj An update on clinical research projects will be presented to the Division, at least twice a year, during the clinical research conferences. 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 7.2.2 The page number of the SOP in “Page X of Y” format for all pages except the table of content pages. Study Conduct and Good Clinical Practice . Journal of Clinical Research Best Practices Vol. ... topic, which vary widely. 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. Use language and detail appropriate to the staff performing the task. �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� Introduction 2 2. Selected Articles from This Issue. SOP S2 Staff CV . 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. Research staff includes the Director of Clinical Research, research coordinators, clinical trial coordinators (data managers), and Unit Business Managers. Human Subjects Research. 5 ... Clinical research sites may also be involved in … Clinical Trial Site SOPs - Contents . Title of SOP: Clinical Research Study Files Revision Letter: Rev. 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 4: Documenting Informed Consent . Use short sentences to express a single thought wherever possible. SOP S4 Site Staff Education and Training . SOP TOC – titles only EMS Research Standard Operating Procedures (SOPs) Emergency Health Services . 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 2: Delegation of Responsibility . Clinical trial agreement log. (919) 681-7760globalhealth.duke.edu 4 Purpose The purpose of this SOP is to describe the processes involved in, … 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 The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. Standard Operating Procedures Standard Operating Procedures. 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 SOP QA5 Fraud and Misconduct . Next-generation Sequencing of Cerebrospinal Fluid: How Can a Liquid be Like a Solid? Introduction . Use techniques that condense information, e.g., tables, matrices, bulleted lists, checklists, and diagrams. Clin Cancer Res December 1 2020 26 (23) 6075-6075; CCR Translations. SOP S3 Staff Responsibilities, Duties and Job Descriptions . 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. 1 Purpose 1 2 Scope 1 3 Review of clinical trial protocol 1 4 Rights and responsibilities of participant 10 3: Process for Obtaining Informed Consent . Box 90519, Durham, NC 27708, Over 60 SOPs regarding laboratory equipment, supplies, and tests. %%EOF Each section begins with a brief introduction of its purpose and then poses questions to consider to guide content. 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. Table of Contents. Interactions with IEC (Institutional Ethics Committee) SOP. Highlights. This SOP defines the responsibilities of the investigator(s) conducting human-subjects research at 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. RA 201-B: Table of ICH Essential Documents . Document Types Form: Typically, a Microsoft Word or Adobe PDF document containing fields that can be filled-in by the user Guidance: A descriptive narrative offering advice on how to fill out a form correctly, or suggestions on how to manage a certain process List: Contains organized text with reference information Log: May contain lists of events (SAEs, deviations, etc.) 1, No. The Campbell Foundation's SOPs help define the clinical research group’s standard 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 to be archived 2 4. 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 . 6: Submitting Changes in Research Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. Regulatory and Study File Content Template . 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�� � 310 Trent Drive, Durham, NC 27710 Media to be used 10 6. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) Clinical Data Review DZHK-SOP-P-01 Effective date: 01/03/2017 Version: 1.0 Author: Thomas Franke Page 3 of 10 1.1 INTRODUCTION This SOP describes the tools that the data capture system secuTrial®, currently used for DZHK studies, provides to support quality assurance processes regarding clinical … EHS Operations Management . Scope 2 3. endstream endobj startxref 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 … Guideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). 1 Research Manual 2 Research Steering Committee Terms of Reference 3 EMS Research Study Review Process 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. 0 standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances. 2911 0 obj <>stream STANDARD OPERATING PROCEDURES (SOP) TABLE OF CONTENTS Standard Operating Procedures (SOPs) are uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed within a business organization. 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