Data Managers Forum Tues 25 Jul 12 00

Data Managers’ Forum Tues 25 Jul @12: 00 -13: 00 What’s in it for us? Please join us at L 51 Old Main Building, Groote Schuur Hospital – there will be coffee! RSVP annemie. stewart@uct. ac. za

International Council of Harmonization (ICH) Good Clinical Practice (GCP) Definitions Objectives • To provide a unified standard to facilitate the mutual acceptance of clinical data by regulatory authorities • To provide public assurance that the rights, safety and well- being of trial subjects – Quality standard for designing , conducting, recording and are protected reporting trials that involve the • To validate clinical trial data participation of human subjects • International Council for Harmonisation (ICH) of Technical Requirement for pharmaceuticals for Human Use • Good Clinical Practice

What is different ICH-GCP E 6 1996 vs ICH-GCP E 6 (R 2) 2016 • Clinical Trials – Scale and Complexity of Trials – Cost of running trial – Evolution of technology – Strict regulatory frameworks Guidelines have been amended to encourage implementation of improved and more efficient approaches to clinical trial designs , conduct oversight , recording and reporting whilst continuing to ensure human subject protection and reliability of trial results

What is different ICH-GCP E 6 1996 vs ICH-GCP E 6 (R 2) 2016 In the Glossary (section 1) 1. 65 -Validation of Computerized systems – A process of establishing and documenting that the specified requirements of a computerized system can consistently fulfilled. The process is based on risk assessment taking into account the intended use of the system and potential to affect human subject protection and reliability of trial results

What is different ICH-GCP E 6 1996 vs ICH-GCP E 6 (R 2) 2016 New Section: Quality Management (section 5) 5. 0 Quality Management The sponsor should implement a system to manage quality throughout all stages of the trial process. The quality management system should use a risk-based approach as described below; 5. 0. 1 Critical process and data identification – Critical to ensure human subject protection and reliable trail results 5. 0. 2 Risk Identification- @ system level and clinical level 5. 0. 3 Risk Evaluation –Risk =impact x likelihood 5. 0. 4 Risk Control-reduce risks or accept risks according to predefined quality tolerance limits 5. 0. 5 Risk Communication – Document Quality Management activities 5. 0. 6 Risk review-periodically review risk control measures to ascertain QM effective 5. 0. 7 Risk Reporting- describe QM approach and summarise deviation from quality tolerance limits