Clinical Trial Manual Estimated reading: 3 minutes 29 views Authors 0 Introduction Good Clinical Practice (GCP) is a comprehensive quality management system (QM system) that was developed for the clinical testing of medicinal products and medical devices. The QM system is based on the guidelines of the European Community and the International Conference on Harmonization on Good Clinical Practice. It incorporates elements of the ISO 9000 family and the requirements of the Declaration of Helsinki. A conformity check (internal audit or certification) is intended to demonstrate the effectiveness of the elements. 0.1 Good practice in research In Germany, anyone who clinically tests medicinal products must fulfill the requirements of GCP/ICH. The regulatory authorities only recognize trials that have been confirmed to be GCP-compliant by an "independent third party". It is not enough for clients from the pharmaceutical industry to rely on their own good experience with a trial center or the good reputation of the head or his scientific staff at the trial center. With "Good Clinical Practice", the IQ-Institut has developed a QM system for clinical research in a hospital or medical practice as a trial center. The QM system is described in 20 elements. The procedural instructions, forms and working methods required for quality verification are assigned to the elements. 0.2 Establishment of test centers The investigators not only receive the QM manual, but are also advised and supported by Dr. U. Paschen QM-Beratung in the initiation, planning and process organization. Dr. U. Paschen QM-Beratung sets up GCP-compliant trial centers and coordinates cooperation with other clinics and medical practices. A number of sample work instructions are available, which can be adapted to local conditions. 0.3 Conducting clinical trials Dr. U. Paschen QM-Beratung provides quality assurance in the planning, execution and reporting of GCP-compliant trials, data transfer and biometrics, contract design and study coordination. 0.4 Research contracts In the case of research contracts from industry, the DFG or tenders from the federal ministries and participation in public tenders, the QM elements of the GCP are applied analogously for the proof of quality. Coordination centers for clinical trials have now been set up at some university hospitals to provide methodological and organizational support for investigators. The elements of the GCP must also be observed here. 0.5 Quality audit Dr. U. Paschen QM-Beratung carries out audits (protocol audit, in-process audit, on-site audit, on-cause audit, data audit) in the planning, monitoring and reporting sections of clinical trials in phases 1 - 4. A special procedure for random sample audits is used for large amounts of data. Dr. U. Paschen QM-Beratung certifies the conformity of a trial site's QM system with the requirements of Good Clinical Practice. Certificates for trial planning, execution and reporting are issued for individual clinical trials. 0.6 The elements Below you will find the list of elements of Good Clinical Practice with the most important procedural instructions and some work instructions. The QM manual contains statements on the elements and further specifications for the conduct of clinical trials. The QM system is certifiable in accordance with DIN EN ISO 9001:2015. Guide elements 1 SCO Scope Purpose and mission2 MAN Management Management of the research institution3 SUB Subjects Study participants, including ethics4 QuS Quality System Quality management system Cross-process elements 5 PRS Personnel Personnel6 EQU Equipment Resources (space, equipment, material)7 PUR Purchase Procurement8 CSP Customer supplied products Handling test samples Process-related elements 9 PRT Protocol Test planning10 PRC Process Project management11 CON Conditions Test conditions12 DAT Data Management Handling data13 STA Statistics Statistics, biometrics14 REP Reporting Reporting15 ARC Archiving Archiving16 SOP Standard Operating Procedures Working methods17 EVA evaluation development and validation18 COM Communication Communication19 TES Testing exams20 CQI Continuous Quality Improvement Measures for improvement Status: 2013-05-30 Useful links: http://www.clinical-trial-center.de/ MD regulation documentsEdit Attachments Procedural instruction1 SCO Scope Purpose and mission 2 MAN Management 3 SUB Subjects Study participants 4 QUS Quality System Quality management system 5 PRS Personal Staff 6 EQU Equipment devices 7 PUR Purchase Procurement 8 CSP Provided products 9 Pro Protocol test planning 10 PRC Process Control Process Control Monitoring 11 Con Conditions Test conditions 12 Data Data 13 Statistics 14 Reporting Reporting 15 Arc archiving 16 SOP Standard Operating Procedures Work instructions 17 EVA Evaluation Validation 18 COM Communication Communication 19 TES Testing Exam 20 CQI Continuous Improvement Improvement Next - 5.2 Analysis and validation 5.2.01 Evaluation program
