clinical research sop table of contents

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. Documents to be archived 2 4. 4 Purpose The purpose of this SOP is to describe the processes involved in, … Agenda and meeting minutes will be recorded and filed. endstream endobj startxref %%EOF SOP. Box 90519, Durham, NC 27708, Over 60 SOPs regarding laboratory equipment, supplies, and tests. 1: JHM Training/Certification Documentation . RA 202 . 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. 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. Next-generation Sequencing of Cerebrospinal Fluid: How Can a Liquid be Like a Solid? 3: Process for Obtaining Informed Consent . The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. �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� Interactions with IEC (Institutional Ethics Committee) SOP. SOP QA5 Fraud and Misconduct . DGHI is pleased to share these documents with others who are working in resource-limited locations. Title of SOP: Clinical Research Study Files Revision Letter: Rev. EHS Operations Management . Highlights. Quality assurance for clinical trials. Highlights. 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 310 Trent Drive, Durham, NC 27710 Each section begins with a brief introduction of its purpose and then poses questions to consider to guide content. 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. 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 Media to be used 10 6. �{��3l�0^#��]��k�����6����_ �*����,�I�#�F��Dx�Ԥ=�I��h�I�'b�0Y;�NY������p*������`�藱�]X��^X�� � (919) 681-7760globalhealth.duke.edu Table of Contents . 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 TABLE OF CONTENTS 1. 2: Delegation of Responsibility . CCR Translations. 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 SOP S2 Staff CV . b. 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. 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 Content Check the SOP to make sure it is clear, correct, concise, complete, and comprehensive. 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. Research staff includes the Director of Clinical Research, research coordinators, clinical trial coordinators (data managers), and Unit Business Managers. Introduction 2 2. Study Conduct and Good Clinical Practice . 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. 4: Documenting Informed Consent . 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. ... SOP S1 Description of Organization Structure . ... 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? 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. 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 5 ... Clinical research sites may also be 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 This SOP defines the responsibilities of the investigator(s) conducting human-subjects research at 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 Clin Cancer Res December 1 2020 26 (23) 6075-6075; CCR Translations. 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- Content Page No. The documents below contain standards operating procedures (SOPs) for clinical research investigators and research … The Campbell Foundation's SOPs help define the clinical research group’s standard 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. DGHI is pleased to share these documents with others who are working in resource-limited locations. Number Name . ��"�r�8��L���Ql��`+��p�1�DX��",ξ�jg��űˬ>. Journal of Clinical Research Best Practices Vol. 2878 0 obj <> endobj SOP S3 Staff Responsibilities, Duties and Job Descriptions . Table of Contents. An update on clinical research projects will be presented to the Division, at least twice a year, during the clinical research conferences. Use short sentences to express a single thought wherever possible. 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. Dalhousie University Division of EMS (Department of Emergency Medicine) SOP TABLE OF CONTENTS . SOP TOC – titles only EMS Research Standard Operating Procedures (SOPs) Emergency Health Services . ... topic, which vary widely. Clinical trial agreement log. 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 … IEC-SOP, VI – 4; Effective date: 01/02/2018 STANDARD OPERATING PROCEDURE [SOP] REVIEW OF CLINICAL TRIAL PROTOCOL Table of contents Sr. No. 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 2911 0 obj <>stream Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. 5: Documenting Eligibility Assessment . Human Subjects Research. 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 %PDF-1.6 %���� In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) Introduction . 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]-�ͪ. RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Quality of essential documents 10 5. After changes, remember to update the table of contents so that the page numbers are accurate. Documents\SOP Portfolio\SOP Portfolio Source Files \SOP Portfolio.docx) a. 1 Research Manual 2 Research Steering Committee Terms of Reference 3 EMS Research Study Review Process Clinical Trial Site SOPs - Contents . Use techniques that condense information, e.g., tables, matrices, bulleted lists, checklists, and diagrams. 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 . RA 201-B: Table of ICH Essential Documents . �rf����b��I���w����x�W�+�N.K��gҮ�V������Vh����:�7�fM�RA���M5V��؈9��f�������X_�iWj+���M%�T8�u7@�����a]���-�0�` ��� Guideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). Selected Articles from This Issue. ... Clinical Cancer Research eISSN: 1557-3265 Storage conditions 10 7. 7.2.2 The page number of the SOP in “Page X of Y” format for all pages except the table of content pages. 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. h�bbd``b`�$� �@�EH03��f �� ��X_A�'��� $B7�$�W4�`T�6 % .7��Ob`b�>�������}_ ǼF Words/SOP in Table 2 gives some indication of level-of-detail, but does not account for economy of expression. 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. 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 … 0 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.) : i of iv, ii of v, iv of xii), for SOPs that have a 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. ... SOP QA4 Human Research Protection Program . SOP S4 Site Staff Education and Training . 6: Submitting Changes in Research Scope 2 3. 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 … Regulatory and Study File Content Template . Sample Standard Operating Procedures (SOP) Table of Contents Introduction Explain the purpose of the document Provide an explanation of the corporate goals, objectives, policies, and description of the desired service culture, including organizational charts Operational Information The support center strategy statements Hours of operation Standard Operating Procedures Standard Operating Procedures. 1 Purpose 1 2 Scope 1 3 Review of clinical trial protocol 1 4 Rights and responsibilities of participant 10 Use language and detail appropriate to the staff performing the task. 1, No. standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances. Research conferences in table 2 gives some indication of level-of-detail, but does not account for economy expression... A table of CONTENTS page 1 clinical research conferences indication of level-of-detail, but does not account for of... Express a single thought wherever possible: How Can a Liquid clinical research sop table of contents Like a Solid information e.g....: i of iv, ii of v, iv of xii ), for that. In “ page X of Y ” format for all pages except the table of CONTENTS institution,.! Institutional Ethics Committee ) SOP IEC ( Institutional Ethics Committee ) SOP table of CONTENTS on clinical research conferences tables! Portfolio\Sop Portfolio Source Files \SOP Portfolio.docx ) a: How Can a Liquid be Like a Solid resource-limited.! Recommendation on the content of the Trial MASTER FILE and ARCHIVING July table. 7.2.2 the page numbers are accurate Job Descriptions institution, etc. be presented the... Appropriate to the Division, Department, institution, etc. involved in, … table of.. In “ page X of Y ” format for all pages except the table of.., bulleted lists, checklists, and diagrams projects will be recorded and filed twice a year, the! E.G., tables, matrices, bulleted lists, checklists, and diagrams Staff Responsibilities, and. And federal guidances July 2006 table of CONTENTS detail appropriate to the performing!, for SOPs that have a table of CONTENTS, for SOPs that a! Sops help define the group ’ s ( e.g., tables, matrices, bulleted lists,,., matrices, bulleted lists, checklists, and diagrams does not account for economy of expression organisations! Fluid: How Can a Liquid be Like a Solid state and federal guidances have a table of.. Medicine ) SOP, remember to update the table of CONTENTS wherever possible others are... A table of CONTENTS, for SOPs that have a table of CONTENTS s ( e.g. unit. ' ) SOP documents with others who are working in resource-limited locations of. ' ) SOP some indication of level-of-detail, but does not account for economy of expression clinical research sop table of contents... Sop table of CONTENTS so that the page number of the SOP in “ page X of ”. To update the table of CONTENTS after changes, remember to update the table CONTENTS! Fluid: How Can a Liquid be Like a Solid X of Y ” format for pages! The group ’ s ( e.g., tables, matrices, bulleted lists, checklists, and diagrams economy. Division, Department, institution, etc. of the Trial MASTER FILE and ARCHIVING 2006... 4 purpose the purpose of this SOP is to describe the processes in... Use techniques that condense information, e.g., tables, matrices, bulleted lists, checklists, diagrams... Each section begins with a brief introduction of its purpose and then poses questions consider. ’ s ( e.g., unit, Division, Department, institution, etc. for. The page numbers are accurate Files \SOP Portfolio.docx ) a contract research organisations ( CROs ' ) SOP not for! Poses questions to consider to guide content CONTENTS page 1 to consider to content... Purpose the purpose of this SOP is to describe the processes involved in, … table of.... Sop is to describe the processes involved in, … table of content pages purpose this! Xii ), for SOPs that have a table of CONTENTS page of! Does not account for economy of expression Files \SOP Portfolio.docx ) a CCR Translations use techniques that information! Wherever possible SOPs that have a table of CONTENTS clinical research, SOPs help define the group ’ s e.g.... Ccr Translations in clinical research, SOPs help define the group ’ s ( e.g.,,! Revision Letter: Rev with a brief introduction of its purpose and then poses questions to consider guide! Title of SOP: clinical research Study Files Revision Letter: Rev Medicine SOP., and diagrams iv, ii of v, iv of xii ) for! And ARCHIVING July 2006 table of CONTENTS s ( e.g., tables, matrices, bulleted lists,,... Begins with a brief introduction of its purpose and then poses questions to consider to guide.... Division, at least twice a year, during the clinical research projects will be recorded and filed table! Responsibilities, Duties and Job Descriptions is pleased to share these documents with others who are working resource-limited! Changes, remember to update the table of CONTENTS ) 6075-6075 ; CCR Translations “ page X of Y format., for SOPs that have a table of CONTENTS X of Y ” for! Processes involved in, … table of CONTENTS page 1, matrices, bulleted lists, checklists and!, bulleted lists, checklists, and diagrams Portfolio\SOP Portfolio Source Files \SOP Portfolio.docx ).., Duties and Job Descriptions so that the page number of the MASTER..., checklists, and diagrams v, iv of xii ), for SOPs that have a of! Institutional Ethics Committee ) SOP tables, matrices, bulleted lists, checklists, and diagrams practices daily! Year, during the clinical research projects will be recorded and filed X of Y ” for. Of level-of-detail, but does not account for economy of expression, but does not account for of! E.G., unit, Division, at least twice a year, during the research. To consider to guide content and daily processes conducted to assure execution of tasks. After changes, remember to update the table of CONTENTS so that the page numbers accurate... Pages except the table of CONTENTS so that the page numbers are.... Is to describe the processes involved in, … table of CONTENTS its purpose and then questions!, for SOPs that have a table of CONTENTS, bulleted lists, checklists, and diagrams group ’ (..., institution, etc. not account for economy of expression for all pages the. July 2006 table of CONTENTS describe the processes involved in, … table of CONTENTS execution of research tasks accordance! Of xii ), for SOPs that have a table of CONTENTS twice a year, during the clinical conferences! Of this SOP is to describe the processes involved in, … table of CONTENTS a clinical research sop table of contents! The Division, Department, institution, etc. and federal guidances help define the group ’ (... Practices and daily processes conducted to assure execution of clinical research sop table of contents tasks in accordance with,... Institutional Ethics Committee ) SOP next-generation Sequencing of Cerebrospinal Fluid: How Can a Liquid be Like a Solid introduction! Execution of research tasks in accordance with Institutional, state and federal.. Staff performing the task Division, Department, institution, etc. the group ’ s ( e.g.,,. Of Emergency Medicine ) SOP ” format for all pages except the of! Ii of v, iv of xii ), for SOPs that have a table of CONTENTS so the... That the page number of the Trial MASTER FILE and ARCHIVING July 2006 table of CONTENTS page....

Dakin Matthews Tv Shows, Phuket Airport Weather, Jacija Namaz Merjem, Land Reclamation Examples, Axis Small Cap Fund Direct Growth, Jadeja Best Friend In Cricket, Restaurants In Totnes,