SOP S4 Site Staff Education and Training . 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 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. 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. 2911 0 obj <>stream 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.) 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\SOP Portfolio\SOP Portfolio Source Files \SOP Portfolio.docx) a. Box 90519, Durham, NC 27708, Over 60 SOPs regarding laboratory equipment, supplies, and tests. IEC-SOP, VI – 4; Effective date: 01/02/2018 STANDARD OPERATING PROCEDURE [SOP] REVIEW OF CLINICAL TRIAL PROTOCOL Table of contents Sr. No. 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 … Research staff includes the Director of Clinical Research, research coordinators, clinical trial coordinators (data managers), and Unit Business Managers. Title of SOP: Clinical Research Study Files Revision Letter: Rev. 3: Process for Obtaining Informed Consent . EHS Operations Management . 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- Standard Operating Procedures Standard Operating Procedures. Quality assurance for clinical trials. 1 Research Manual 2 Research Steering Committee Terms of Reference 3 EMS Research Study Review Process 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. 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. RA 201-B: Table of ICH Essential Documents . Dalhousie University Division of EMS (Department of Emergency Medicine) SOP TABLE OF CONTENTS . Content Check the SOP to make sure it is clear, correct, concise, complete, and comprehensive. %%EOF SOP QA5 Fraud and Misconduct . 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 . ... SOP S1 Description of Organization Structure . SOP TOC – titles only EMS Research Standard Operating Procedures (SOPs) Emergency Health Services . 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 0 The Campbell Foundation's SOPs help define the clinical research group’s standard 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 Regulatory and Study File Content Template . �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� In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) 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. 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