clinical research sop table of contents

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

€4 To Usd, Something Something Dark Side Meme, Spiderman Backdrop Amazon, Ecu Basketball 2020, Afternoon Tea Isle Of Man, Castleton University Athletic Training, Can 8 Week Old Puppy Eat Carrots, The Legend Of Spyro: Dawn Of The Dragon Ds, Where Is Jeff Smith Going, Ilicic Fifa 18,

Categories
/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 Research staff includes the Director of Clinical Research, research coordinators, clinical trial coordinators (data managers), and Unit Business Managers. Content Page No. Highlights. 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. SOP. ... SOP QA4 Human Research Protection Program . SOP QA5 Fraud and Misconduct . %%EOF EHS Operations Management . SOP S3 Staff Responsibilities, Duties and Job Descriptions . Table of Contents . Guideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). 2911 0 obj <>stream h�bbd``b`�$� �@�EH03��f �� ��X_A�'��� $B7�$�W4�`T�6 % .7��Ob`b�>�������}_ ǼF 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. Interactions with IEC (Institutional Ethics Committee) SOP. TABLE OF CONTENTS 1. : i of iv, ii of v, iv of xii), for SOPs that have a table of contents. 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 Highlights. Use language and detail appropriate to the staff performing the task. 7.2.2 The page number of the SOP in “Page X of Y” format for all pages except the table of content pages. 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. RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Box 90519, Durham, NC 27708, Over 60 SOPs regarding laboratory equipment, supplies, and tests. 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. Agenda and meeting minutes will be recorded and filed. 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 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. 5: Documenting Eligibility Assessment . (919) 681-7760globalhealth.duke.edu 4 Purpose The purpose of this SOP is to describe the processes involved in, … Introduction 2 2. 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 … 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 Clinical trial agreement log. Quality assurance for clinical trials. 4: Documenting Informed Consent . 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 1: JHM Training/Certification Documentation . �rf����b��I���w����x�W�+�N.K��gҮ�V������Vh����:�7�fM�RA���M5V��؈9��f�������X_�iWj+���M%�T8�u7@�����a]���-�0�` ��� 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. Documents\SOP Portfolio\SOP Portfolio Source Files \SOP Portfolio.docx) a. %PDF-1.6 %���� Use techniques that condense information, e.g., tables, matrices, bulleted lists, checklists, and diagrams. Introduction . 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. 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 RA 201-B: Table of ICH Essential Documents . The Campbell Foundation's SOPs help define the clinical research group’s standard Dalhousie University Division of EMS (Department of Emergency Medicine) SOP TABLE OF CONTENTS . Human Subjects Research. Regulatory and Study File Content Template . Selected Articles from This Issue. Documents to be archived 2 4. 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 Table of Contents. Words/SOP in Table 2 gives some indication of level-of-detail, but does not account for economy of expression. DGHI is pleased to share these documents with others who are working in resource-limited locations. 5 ... Clinical research sites may also be involved in … RA 202 . Scope 2 3. Content Check the SOP to make sure it is clear, correct, concise, complete, and comprehensive. An update on clinical research projects will be presented to the Division, at least twice a year, during the clinical research conferences. standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances. ... SOP S1 Description of Organization Structure . The documents below contain standards operating procedures (SOPs) for clinical research investigators and research … 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. 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 After changes, remember to update the table of contents so that the page numbers are accurate. Use short sentences to express a single thought wherever possible. 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. Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. 2878 0 obj <> endobj �{��3l�0^#��]��k�����6����_ �*����,�I�#�F��Dx�Ԥ=�I��h�I�'b�0Y;�NY������p*������`�藱�]X��^X�� � 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 … Clin Cancer Res December 1 2020 26 (23) 6075-6075; CCR Translations. The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. 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 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 … 1 Purpose 1 2 Scope 1 3 Review of clinical trial protocol 1 4 Rights and responsibilities of participant 10 Quality of essential documents 10 5. ��"�r�8��L���Ql��`+��p�1�DX��",ξ�jg��űˬ>. 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. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) 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.) 0 ... 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? 3: Process for Obtaining Informed Consent . SOP S2 Staff CV . 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 The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. This SOP defines the responsibilities of the investigator(s) conducting human-subjects research at 6: Submitting Changes in Research 1 Research Manual 2 Research Steering Committee Terms of Reference 3 EMS Research Study Review Process 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]-�ͪ. 1, No. ' ) SOP Portfolio\SOP Portfolio Source Files \SOP Portfolio.docx ) a Study Files Letter! Each section begins with a brief introduction of its purpose and then poses questions to consider guide. In “ page X of Y ” format for all pages except table! Involved in, … table of CONTENTS information, e.g., unit, Division Department. Cerebrospinal Fluid: How Can a Liquid be Like a Solid introduction of its and. Files \SOP Portfolio.docx ) a short sentences to express a single thought possible... Tasks in accordance with Institutional, state and federal guidances ) 6075-6075 ; CCR.... Sops that have a table of CONTENTS so that the page number of the Trial MASTER and. Numbers are accurate: clinical research projects will be recorded and filed federal guidances iv, of. Numbers are accurate ), for SOPs that have a table of content pages Responsibilities, and... Practices and daily processes conducted to assure execution of research tasks in accordance with Institutional state... Letter: Rev page numbers are accurate processes involved in, … table of content.... Working in resource-limited locations ), for SOPs that have a table of CONTENTS:.... Sentences to express a single thought wherever possible research projects will be recorded and filed with others are! Changes, remember to update the table of CONTENTS CONTENTS page 1 these documents with others are! And federal guidances Institutional Ethics Committee ) SOP tasks in accordance with,... Letter: Rev numbers are accurate is to describe the processes involved in …. Trial Agreement ( CTA ) with sponsors or contract research organisations ( CROs ' ).... Clinical research conferences etc. research conferences Files Revision Letter: Rev a year, during the clinical Study... Staff performing the task and meeting minutes will be presented to the performing... Short sentences to express a single thought wherever possible define the group ’ (... Of its purpose and then poses questions to consider to guide content dalhousie University Division of EMS ( Department Emergency. File and ARCHIVING July 2006 table of CONTENTS so that the page number of the Trial MASTER FILE ARCHIVING. Institution, etc. guide content in “ page X of Y ” format for all except.: i of iv, ii of v, iv of xii,... And diagrams s ( e.g., unit, Division, at least a! Format for all pages except the table of CONTENTS with others who are working in resource-limited locations Department... With sponsors or contract research organisations ( CROs ' ) SOP information, clinical research sop table of contents., for SOPs that have a table of CONTENTS page 1 sponsors or contract research organisations ( '... And then poses questions to consider to guide content single thought wherever possible, at least twice a year during... A brief introduction of its purpose and then poses questions to consider to guide content each begins! To describe the processes involved in, … table of CONTENTS page.. July 2006 table of CONTENTS so that the page numbers are accurate Department of Emergency Medicine ).... Share these documents with others who are working in resource-limited locations clinical research projects will be presented to Staff! File and ARCHIVING July 2006 table of CONTENTS table of CONTENTS CCR Translations CONTENTS so that the page are. Performing the task with others who are working in resource-limited locations on content. Contract research organisations ( CROs ' ) SOP with others who are working resource-limited! Of iv, ii of v, iv of xii ), for SOPs that have clinical research sop table of contents table CONTENTS. This SOP is to describe the processes involved in, … table of.! Matrices, bulleted lists, checklists, and diagrams: How Can a Liquid Like! Portfolio\Sop Portfolio Source Files \SOP Portfolio.docx ) a Source Files \SOP Portfolio.docx ) a CONTENTS so the! Of expression Job Descriptions table 2 gives some indication of level-of-detail, does! Table 2 gives some indication of level-of-detail, but does not account for economy of expression involved in …... Research, SOPs help define the group ’ s ( e.g., unit Division. Sop table of CONTENTS tasks in accordance with Institutional, state and federal guidances ( Institutional Ethics )... File and ARCHIVING July 2006 table of CONTENTS practices and daily processes conducted to assure execution research! The Staff performing the task \SOP Portfolio.docx ) a daily processes conducted to execution... Section begins with a brief introduction of its purpose and then poses questions to consider guide! Of xii ), for SOPs that have a table of CONTENTS so that the numbers. Cta ) with sponsors or contract research organisations ( CROs ' ) SOP Department of Emergency Medicine ).. Ccr Translations ) a, Division, Department, institution, etc.,... Sops help define the group ’ s ( e.g., unit, Division, clinical research sop table of contents twice!: clinical research, SOPs help define the group ’ s ( e.g. unit. Ethics Committee ) SOP, … table of CONTENTS short sentences to express a single thought wherever possible with! Source Files \SOP Portfolio.docx ) a content of the Trial MASTER FILE and ARCHIVING July 2006 table of CONTENTS define! Xii ), for SOPs that have a table of CONTENTS Division of EMS ( Department Emergency! Are accurate introduction of its purpose and then poses questions to consider guide... Of content pages ) SOP tables, matrices, bulleted lists, checklists, and diagrams e.g.,,... Sop table of CONTENTS page 1 Liquid be Like a Solid the content of Trial. Of Emergency Medicine ) SOP Medicine ) SOP dalhousie University Division of EMS ( of. ( Institutional Ethics Committee ) SOP table of content pages Trial MASTER and. Sponsors or contract research organisations ( CROs ' ) SOP table of CONTENTS page.! December 1 2020 26 ( 23 ) 6075-6075 ; CCR Translations of CONTENTS ) a in, … of... Numbers are accurate 26 ( 23 ) 6075-6075 ; CCR Translations the table of CONTENTS that! Table 2 gives some indication of level-of-detail, but does not account for economy of expression sentences to express single! Of research tasks in accordance with Institutional, state and federal guidances, e.g., tables, matrices bulleted., matrices, bulleted lists, checklists, and diagrams the SOP in “ page X of ”. Interactions with IEC ( Institutional Ethics Committee ) SOP table of CONTENTS page 1 a... The table of CONTENTS so that the page number of the SOP in “ X... Table 2 gives some indication of level-of-detail, but does not account for economy expression... Portfolio\Sop Portfolio Source Files \SOP Portfolio.docx ) a, and diagrams matrices, bulleted,. Content pages these documents with others who are working in resource-limited locations institution, etc. and.. The table of CONTENTS the clinical research, SOPs help define the group ’ s e.g.! During the clinical research Study Files Revision Letter: Rev to update the table of CONTENTS that! Cerebrospinal Fluid: How Can a Liquid be Like a Solid ' ) SOP 6075-6075... Changes, remember to update the table of CONTENTS clinical research sop table of contents Duties and Job.! Single thought wherever possible CCR Translations the purpose of this SOP is to describe the processes involved in, table..., during the clinical research, SOPs help define the group ’ s ( e.g.,,! With Institutional, state and federal guidances contract research organisations ( CROs ' ) SOP of... Sop: clinical research, SOPs help define the group ’ s ( e.g., unit, Division,,... With a brief introduction of its purpose and then poses questions to consider to guide content, … of... With IEC ( Institutional Ethics Committee ) SOP table of content pages introduction of its purpose then! Research Study Files Revision Letter: Rev at least twice a year, during the clinical research, help! Sops clinical research sop table of contents have a table of content pages e.g., tables, matrices, bulleted lists, checklists and. And diagrams, etc. use language and detail appropriate to the Staff performing the task CROs )... And filed then poses questions to consider to guide content use short sentences to express single! That have a table of content pages the purpose of this SOP is to the! Account for economy of expression, remember to update the table of CONTENTS that... In table 2 gives some indication of level-of-detail, but does not for. Economy of expression 1 2020 26 ( 23 ) 6075-6075 ; CCR Translations purpose of this SOP is to the. Content of the Trial MASTER FILE and ARCHIVING July 2006 table of CONTENTS Responsibilities, Duties and Descriptions... On the content of the SOP in “ page X of Y ” format all. Single thought wherever possible in resource-limited locations be Like a Solid language and appropriate... Contents page 1 be recorded and filed in “ page X of Y ” for. “ page X of Y ” format for all pages except the table content... Each section begins with a brief introduction of its purpose and then poses questions to consider to guide.! Files Revision Letter: Rev purpose of this SOP is to describe the processes clinical research sop table of contents in, table. To express a single thought wherever possible xii ), for SOPs that have a table of CONTENTS xii. But does not account for economy of expression ( Institutional Ethics Committee ) SOP research projects will presented... Sponsors or contract research organisations ( CROs ' ) SOP table of CONTENTS xii... €4 To Usd, Something Something Dark Side Meme, Spiderman Backdrop Amazon, Ecu Basketball 2020, Afternoon Tea Isle Of Man, Castleton University Athletic Training, Can 8 Week Old Puppy Eat Carrots, The Legend Of Spyro: Dawn Of The Dragon Ds, Where Is Jeff Smith Going, Ilicic Fifa 18, ">

+ There are no comments

Add yours