Study Sponsors and Clinical Trial Monitoring Trial specific factors such as the number of planned/recruited trial subjects per trial and per site plus recruiting velocity and the kind of collected CRF data. She further stated that some statistical methods seem to be less reliable, for small trials or other low-data volume conditions and for large trials with small numbers of subjects per site. 4.10 Q. What is the purpose and content of the Integrated Quality Risk Management Plan (IQRMP)? A. Study quality is a shared responsibility across all functions involved in collecting, analyzing and reporting clinical trial data. The IQRMP provides a tailored and integrated plan for a specific clinical trial that will: * Include the clinical and medical risks identified at the program level * Define the actions that each function will take to proactively identify, assess, and manage risk throughout the life of a clinical trial * Define the critical data variables identified by cross - functional representatives (e.g. elements and/or processes that impact primary efficacy endpoint and critical safety parameters) * Align associated quality management plans (including the monitoring plan) across identified risks and defined critical data variables, so that cross-functional teams can focus on the risks that are most important to patient safety, data integrity and regulatory compliance * Describe the process that all functions will follow to review and revise the IQRMP throughout the life of the program and clinical trial(s) The IQRMP is not intended to duplicate the content of existing functional plans; these can be linked or referenced within the IQRMP so that the accountability remains with the relevant function. Inputs (content) to the IQRMP include but are not limited to: * Clinical Development Plan * Regulatory Strategy * Risk Assessment and Categorization Tool * Critical Data * Any existing program or product risk management plans The procedures and activities described within the IQRMP should not duplicate Standard Operating Procedures or other documented guidance. The IQRMP should describe the trial specific actions/processes that will be implemented to focus on the specific risks and critical data variables identified. It is recommended that the overall accountability for the development and maintenance of the IQRMP is assigned to a centralized function such as project or program management to ensure that the key elements are aligned across all functions. The Recommended / Potential Risk Elements within the IQRMP can be found on the TransCelerate website at: www.transceleratebiopharmainc.com 4.11 Q. What is Adaptive Monitoring? A. An approach to clinical trial monitoring that directs the monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data integrity (quality.) 4.12 Q. What is Centralized Monitoring? A. Centralized monitoring is a remote evaluation of ongoing and/or cumulative data collected from trial sites, in a timely manner. Centralized monitoring processes provide additional monitoring capabilities that can complement and reduce the extent and/or frequency of on-site monitoring. 4.13 Q. The ICH GCP E6 addendum states the need for many well-established processes in order to align the GCP with reality (e.g., validation of computerized systems or centralized monitoring). Where is this covered and what are the new key points? A. It is covered under Section 5.5-Trial Management, Data Handling and Record Keeping. The following was added: 131http://www.transceleratebiopharmainc.com