clinical research sop table of contents

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Guideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). 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]-�ͪ. 7.2.3 The Table of Contents page numbers will be in lower case Roman numeral format, where the last number is the total number of pages in the table of contents (e.g. �rf����b��I���w����x�W�+�N.K��gҮ�V������Vh����:�7�fM�RA���M5V��؈9��f�������X_�iWj+���M%�T8�u7@�����a]���-�0�` ��� 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 . 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.) Number Name . Box 90519, Durham, NC 27708, Over 60 SOPs regarding laboratory equipment, supplies, and tests. RA 201-B: Table of ICH Essential Documents . Sample paragraphs are included for reference; however, it is important to note that the sample paragraphs were geared for illustration purposes toward a specific SOP example. An update on clinical research projects will be presented to the Division, at least twice a year, during the clinical research conferences. 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 … Clinical trial agreement log. (919) 681-7760globalhealth.duke.edu 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 3: Process for Obtaining Informed Consent . 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 0 Selected Articles from This Issue. 1, No. Table of Contents. The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. Interactions with IEC (Institutional Ethics Committee) SOP. 6: Submitting Changes in Research The documents below contain standards operating procedures (SOPs) for clinical research investigators and research … Regulatory and Study File Content Template . RA 202 . ... 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? Media to be used 10 6. 2911 0 obj <>stream %%EOF 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 Table of Contents . 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. 1 Purpose 1 2 Scope 1 3 Review of clinical trial protocol 1 4 Rights and responsibilities of participant 10 ... Clinical Cancer Research eISSN: 1557-3265 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. 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. %PDF-1.6 %���� SOP QA5 Fraud and Misconduct . Copy and paste just the body text of the new/revised SOP into the main portfolio; copying the header and the log of changes often led to formatting issues. Although most of these SOPs were developed for AIDS clinical trials, many of these documents can be modified and extrapolated to meet your specific project needs. IEC-SOP, VI – 4; Effective date: 01/02/2018 STANDARD OPERATING PROCEDURE [SOP] REVIEW OF CLINICAL TRIAL PROTOCOL Table of contents Sr. No. �{��3l�0^#��]��k�����6����_ �*����,�I�#�F��Dx�Ԥ=�I��h�I�'b�0Y;�NY������p*������`�藱�]X��^X�� � 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. Quality of essential documents 10 5. ... SOP QA4 Human Research Protection Program . This SOP defines the responsibilities of the investigator(s) conducting human-subjects research at 1: JHM Training/Certification Documentation . 4: Documenting Informed Consent . Words/SOP in Table 2 gives some indication of level-of-detail, but does not account for economy of expression. Use language and detail appropriate to the staff performing the task. ��"�r�8��L���Ql��`+��p�1�DX��",ξ�jg��űˬ>. The Campbell Foundation's SOPs help define the clinical research group’s standard RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. 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 … 4 Purpose The purpose of this SOP is to describe the processes involved in, … The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. A table of contents A scope and applicability section that explains why the SOP was prepared, to what the SOP applies, the regulations or laws it satisfies and any limitations on the use of the SOP 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 SOP vs. MOP •Founded in federal regulations and guidance, Good Clinical Practice guidelines, and institutional policies and guidance •General processes common to running all studies •Infrequent changes •Established in a grant, protocol, and/or IRB application •Study-specific processes to gather data for one study’s research aims 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- Study Conduct and Good Clinical Practice . Clin Cancer Res December 1 2020 26 (23) 6075-6075; CCR Translations. The guidance also applies to the legal representatives and contract research organisation (CROs), which according to the ICH GCP guideline includes any third party such as Human Subjects Research. Introduction 2 2. Highlights. Each section begins with a brief introduction of its purpose and then poses questions to consider to guide content. 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 b. 1 Research Manual 2 Research Steering Committee Terms of Reference 3 EMS Research Study Review Process standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances. 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