3: Process for Obtaining Informed Consent . This SOP defines the responsibilities of the investigator(s) conducting human-subjects research at Interactions with IEC (Institutional Ethics Committee) SOP. 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 SOP S3 Staff Responsibilities, Duties and Job Descriptions . Words/SOP in Table 2 gives some indication of level-of-detail, but does not account for economy of expression. %PDF-1.6 %���� 5 ... Clinical research sites may also be involved in … Research staff includes the Director of Clinical Research, research coordinators, clinical trial coordinators (data managers), and Unit Business Managers. IEC-SOP, VI – 4; Effective date: 01/02/2018 STANDARD OPERATING PROCEDURE [SOP] REVIEW OF CLINICAL TRIAL PROTOCOL Table of contents Sr. No. 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 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. endstream endobj startxref %%EOF standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances. Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. Regulatory and Study File Content Template . 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 TOC – titles only EMS Research Standard Operating Procedures (SOPs) Emergency Health Services . 5: Documenting Eligibility Assessment . Dalhousie University Division of EMS (Department of Emergency Medicine) SOP TABLE OF CONTENTS . Scope 2 3. 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. �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� ... topic, which vary widely. SOP. Table of Contents . ... Clinical Cancer Research eISSN: 1557-3265 Title of SOP: Clinical Research Study Files Revision Letter: Rev. RA 202 . Use short sentences to express a single thought wherever possible. 6: Submitting Changes in Research 2911 0 obj <>stream The Campbell Foundation's SOPs help define the clinical research group’s standard The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. 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 2878 0 obj <> endobj 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. 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. Study Conduct and Good Clinical Practice . 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 … The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. Next-generation Sequencing of Cerebrospinal Fluid: How Can a Liquid be Like a Solid? 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. 1, No. 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. Clinical Trial Site SOPs - 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 2: Delegation of Responsibility . TABLE OF CONTENTS 1. 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 DGHI is pleased to share these documents with others who are working in resource-limited locations. 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 �{��3l�0^#��]��k�����6����_ �*����,�I�#�F��Dx�Ԥ=�I��h�I�'b�0Y;�NY������p*������`�藱�]X��^X�� � Use language and detail appropriate to the staff performing the task. 4: Documenting Informed Consent . Documents to be archived 2 4. 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 S4 Site Staff Education and Training . 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. Human Subjects Research. 1: JHM Training/Certification Documentation . 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 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 An update on clinical research projects will be presented to the Division, at least twice a year, during the clinical research conferences. 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. After changes, remember to update the table of contents so that the page numbers are accurate. Use techniques that condense information, e.g., tables, matrices, bulleted lists, checklists, and diagrams. ... SOP S1 Description of Organization Structure . Guideline (‘ICH GCP guideline’), regarding the structure, content, management and archiving of the clinical trial master file (TMF). Clinical trial agreement log. 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. SOP S2 Staff CV . RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) SOP QA5 Fraud and Misconduct . 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. Introduction . 4 Purpose The purpose of this SOP is to describe the processes involved in, … 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? Journal of Clinical Research Best Practices Vol. Quality assurance for clinical trials. 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. 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. DGHI is pleased to share these documents with others who are working in resource-limited locations. 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 … Media to be used 10 6. �rf����b��I���w����x�W�+�N.K��gҮ�V������Vh����:�7�fM�RA���M5V��؈9��f�������X_�iWj+���M%�T8�u7@�����a]���-�0�` ��� 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 … 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 2 2. 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