SOP #102 - Training Personnel. 17 0 obj %PDF-1.5 8.1 Introduction. It is important to reference applicable guidances and regulations within the SOP, such as ICH E6 Good Clinical Practice and 21 CFR 50. SOP #104 - Conduct of Clinical Study. ICH GCP is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. Box 90519, Durham, NC 27708, Over 60 SOPs regarding laboratory equipment, supplies, and tests. Steps in designing and conducting a clinical trial. The header will then include the SOP number, title, Version number, page number, and effective date. Clinical Trial Monitoring PRM-SOP-015 IMP Labelling PRM-SOP-016 Randomisation, Blinding and Code Breaking PRM-SOP-017 IMP Destruction Return and Recall PRM-SOP-018 Validating Sealed Envelope Systems PRM-SOP-019 Data Handling PRM-SOP-020 Change Control for Sealed Envelope Systems PRM-SOP-021 Obtaining Informed Consent PRM-SOP-022 Non CTIMP Safety Management PRM-SOP-023 … <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/Annots[ 15 0 R] /MediaBox[ 0 0 720 540] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Conducting Clinical Trials During the COVID-19 Public Health Emergency Jacqueline Corrigan -Curay, MD, JD Director, Office of Medical Policy. When Standard Operating Procedures (SOPs) for clinical research are numerous, long, redundant, and overly detailed, they waste time and money and – worst of all – risk compliance. Other trial personnel are responsible for conducting monitoring activities under the direction of the PI in accordance with the delegation log and this procedure. <> 310 Trent Drive, Durham, NC 27710 The Standard Operating Procedure (SOP) project has been sponsored by VMIA as part of it’s risk mitigation for clinical research activity at VMIA insured sites. Bratislava, Slovakia. 4 0 obj (GCP): “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” i. Monitoring is defined as the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, The Principles of GCP, and the Medicines for Human Use (Clinical Trails) Regulations - where applicable. Each SOP should have a specific aim but be written in a general format that can be easily followed by a broad audience. The purpose of this SOP is: To describe the development of … SOP #105 - … 13 0 obj GA-102.01. Pharmacy SOPs Setting up a Clinical Trial CT 1 01 Procedure for the Set-Up of a Clinical Trial in the Pharmacy Trials Unit. NUMBER DATE PAGE HRP-092 3/31/2020 2 of 2 stream clinical trial agreement. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? <> INTRODUCTION AND PURPOSE This standard operating procedure (SOP) describes the processes followed at this investigative site when a study sponsor sends a Clinical Research Associate/ Study Monitor to conduct a monitoring visit. conducting clinical research. <> The Compliance Monitoring Team has created Standard Operating Procedure templates (SOPs) in response to action items discovered in IRB directed audits, FDA audit and site visits, and routine monitoring visits. This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links. 6 0 obj 18 0 obj SOP: Training and Coverage Requirements for Investigators Conducting Clinical Trials and Clinical Investigations NUMBER DATE AUTHOR APPROVED BY PAGE HRP-093 08/23/2017 C. Gates C. Kiel 1 of 1 1 PURPOSE 1.1 This policy establishes the requirements for investigators who conduct clinical trials and clinical investigations. These SOP’s help the research teams, as recommendations for conducting research in the appropriate manner. ��$K��>�u�Z���&6��[�� Training staff on SOPs ensures everyone is doing things the same way. General Administration (GA) GA-101.01. endobj These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. The SOPs are written specifically for the Australian Clinical Trial environment with respect to the scientific and regulatory requirements for the conduct of clinical trials as detailed by the National Health and Medical Research Council (NHMRC) and Therapeutic Goods Authority (TGA), respectively. Maintaining the blind for clinical trials in Pharmacy IT IS THE RESPONSIBILITY OF ALL USERS OF THIS SOP TO ENSURE THAT THE CORRECT VERSION IS BEING USED All staff should regularly check the R&D Unit’s website and/or Q-Pulse for information relating to the implementation of new or revised versions. SOP #103 - Responsibilities of Research Team. Attachment templates include: A: Creating a New Study Record for ClinicalTrials.gov . PURPOSE: This Standard Operating Procedure (SOP) describes the creation of an account and registration of a clinical trial on ClinicalTrials.gov. A sponsor-investigator is responsible for conducting a risk assessment on the clinical trial in Below are some of the commonly referenced SOPs used in the Clinical Research Center. Data Monitoring Committees for Clinical Trial Sponsors, The Establishment and Operation of Clinical Trial - 03/2006 Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - 10/2008 You may edit and adapt for your department. In clinical research, Standard Operating Procedures (SOPs) assist in defining the clinical groups standard practices and daily processes conducted to assure execution of research task in accordance with institutional, state and federal guidelines. DGHI is pleased to share these documents with others who are working in resource-limited locations. Clinical trial registration happens when countries seek to improve the transparency of clinical trial research involving nationals of that country, and to be more accountable to the individuals who consent to participate in clinical research, and to better oversee and monitor that research. Amended by the following legal instruments (show) The Office of Quality Compliance has created Standard Operating Procedures (SOPs) to be used by all individuals participating in clinical research at the University of Utah. SOP. endobj <> �,�))�O2�W3�\j��NRsx��ē��Gx�I^MzjF�4�j�1�=�Q��Z���v�GQu��g���@�(��� tP�",5�;���r�\J�i�٣�áO1�ch���5�}��Bei����ȹ��I8���yi�� �.���gѫˤ!�=����C���*��C�Y���m����Ӽ���( (��}�9c���N`c��:a{��N��0�F�Eπ��Ot{i���Vx�C"G&'=��F��"��|AU���}��h���/ Ie�%������[���x�6~�௿v��i�C�F���'x����a\^Ok�Wb ��k1?E���/V�R�q��L(X��[ ��%� �50��}{?p�8�}#��_"���$����;����6��?���46^�6���E��y�Irɘd�,٤�^�qr�F�@�SaU01 L/�od� <> CLINICAL TRIAL (CT): Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome. List of Standard Operating Procedures. Sites conducting industry -sponsored research all NETT personnel ( including Contract research ). By, but not limited to a member of quality Assurance Mon, 06/29/2015 - 00:05 ICH E6 clinical. 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