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. Clin Cancer Res December 1 2020 26 (23) 6075-6075; CCR Translations. RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. �rf����b��I���w����x�W�+�N.K��gҮ�V������Vh����:�7�fM�RA���M5V��؈9��f�������X_�iWj+���M%�T8�u7@�����a]���-�0�` ���
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 Number Name . Research staff includes the Director of Clinical Research, research coordinators, clinical trial coordinators (data managers), and Unit Business Managers. 2898 0 obj
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��"�r�8��L���Ql��`+��p�1�DX��",ξ�jg��űˬ>. EHS Operations Management . This SOP defines the responsibilities of the investigator(s) conducting human-subjects research at 1 Purpose 1 2 Scope 1 3 Review of clinical trial protocol 1 4 Rights and responsibilities of participant 10 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 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 Use short sentences to express a single thought wherever possible. endstream
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: i of iv, ii of v, iv of xii), for SOPs that have a table of contents. Table of Contents. RA 201-B: Table of ICH Essential Documents . Media to be used 10 6. TABLE OF CONTENTS 1. Content Check the SOP to make sure it is clear, correct, concise, complete, and comprehensive. ... SOP S1 Description of Organization Structure . 5 ... Clinical research sites may also be involved in … Scope 2 3. Dalhousie University Division of EMS (Department of Emergency Medicine) SOP TABLE OF CONTENTS . DGHI is pleased to share these documents with others who are working in resource-limited locations. SOP QA5 Fraud and Misconduct . 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. Quality assurance for clinical trials. 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. Use language and detail appropriate to the staff performing the task. Agenda and meeting minutes will be recorded and filed. Clinical trial agreement log. 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. 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. 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 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. The Campbell Foundation's SOPs help define the clinical research group’s standard %PDF-1.6
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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. (919) 681-7760globalhealth.duke.edu 0
Next-generation Sequencing of Cerebrospinal Fluid: How Can a Liquid be Like a Solid? 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 … ... Clinical Cancer Research eISSN: 1557-3265 Clinical Trial Site SOPs - Contents . Each section begins with a brief introduction of its purpose and then poses questions to consider to guide content. 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��$j\�ʄ����iN>u[��}���5�� ����p����p��I��R���h�զ���������wEW�E��֛�n4B���l:�3tZl^���#�:+��)4��Ū����N&믗'�hF�.��+:/n����x[�s/ySܔ���.� �e����A��>�b��vE]-�ͪ. Quality of essential documents 10 5. A Effective Date: 01 Jan 2012 Step Seven: Have the SOP reviewed, signed, and dated by a member of the research department that has the ability to approve SOPs (this will generally be a research direc- ... INTRODUCTION 3 3.1 Scope of the SOP Project and why it was developed 4 3.2 What is Good Clinical Practice (GCP) 4 3.3 How these SOPs fit into an overall structure of a Quality System? The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. Title of SOP: Clinical Research Study Files Revision Letter: Rev. Introduction . Selected Articles from This Issue. Florida Atlantic University and Memorial Healthcare System have formed a “Research Partnership to Advance Clinical Trials” (Research PACT), which combines their expertise and resources in clinical research, clinical trials, basic research and translational biomedical research. SOP S4 Site Staff Education and Training . �yW��E��/���ض�t�-���{E�Wi���W۶�^[��-���EPZ��˧3���TR>�{�]��V3�3IX�IjM�6��ˈ1�pxRʞ@���ua���c���G"�sƵ�d������,��¼��' x]�{�����)�|�c�p�1 y?���o�M$)���_� R��p�����$�"m���k4GJ� 6: Submitting Changes in Research 7.2.2 The page number of the SOP in “Page X of Y” format for all pages except the table of content pages. Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. 2: Delegation of Responsibility .
Introduction 2 2. h��KSQǟ�vww�S��#Dԥ+�̌�R�P��3&z鎒A�F�a/�J#Dm���]�S��*[ƨQf�0&��$�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 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.) 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. Storage conditions 10 7. 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. 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 … 4 Purpose The purpose of this SOP is to describe the processes involved in, … Highlights. Use techniques that condense information, e.g., tables, matrices, bulleted lists, checklists, and diagrams. Documents to be archived 2 4. 1 Research Manual 2 Research Steering Committee Terms of Reference 3 EMS Research Study Review Process SOP. Content Page 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. 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 … SOP S3 Staff Responsibilities, Duties and Job Descriptions . In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) 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. The documents below contain standards operating procedures (SOPs) for clinical research investigators and research … 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 endstream
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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. 4: Documenting Informed Consent . Guideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). 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 Words/SOP in Table 2 gives some indication of level-of-detail, but does not account for economy of expression. b. h�bbd``b`�$� �@�EH03��f �� ��X_A�'��� $B7�$�W4�`T�6 % .7��Ob`b�>�������}_ ǼF
RA 202 . SOP TOC – titles only EMS Research Standard Operating Procedures (SOPs) Emergency Health Services . After changes, remember to update the table of contents so that the page numbers are accurate. Box 90519, Durham, NC 27708, Over 60 SOPs regarding laboratory equipment, supplies, and tests. Standard Operating Procedures Standard Operating Procedures. 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 Study Conduct and Good Clinical Practice . 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. SOP S2 Staff CV . Documents\SOP Portfolio\SOP Portfolio Source Files \SOP Portfolio.docx) a. Highlights. IEC-SOP, VI – 4; Effective date: 01/02/2018 STANDARD OPERATING PROCEDURE [SOP] REVIEW OF CLINICAL TRIAL PROTOCOL Table of contents Sr. No. ... SOP QA4 Human Research Protection Program . 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. 3: Process for Obtaining Informed Consent . 5: Documenting Eligibility Assessment . %%EOF
Interactions with IEC (Institutional Ethics Committee) SOP. DGHI is pleased to share these documents with others who are working in resource-limited locations. Journal of Clinical Research Best Practices Vol. 1, No. 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 310 Trent Drive, Durham, NC 27710 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. 2878 0 obj
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