Task force National Project management Report
Please complete and return to SCTO at the latest by 30 June 2014
Head task force N.N, CTU St Gallen Participants Meeting / TC dates
1. Service content of a National Network for Project Management in Clinical Trials (key deliverables) The regulatory framework for clinical trials defines general tasks and responsibilities of the sponsor during clinical study projects. From the operational perspective, several processes need to be prepared, pursued and tracked under the responsibility of the sponsor on different operational levels during the life cycle of a clinical study. The established SCTO guidelines for good operational practice summarize these tasks and roughly assign them to the different phases of a clinical study project (from concept to completion). However, this needs to be aligned along a process of chronological and logical order to ultimately allow sponsors, sponsor investigators or support organizations like the CTUs, collaborative research groups and others to structure, oversee and guide the complex machinery of the management of a clinical trial towards safe and successful completion.
The National Network for Project Management in Clinical Trials shall provide a nationwide support infrastructure that is open to all medical disciplines and that enables investigators, sponsor investigators and sponsors to manage the development and conduct of a clinical trial. This infrastructure shall in particular allow to reach the following aims:
1. Derive a realistic study budget from a given trial concept for funding purposes 2. Develop a research proposal into a clinical trial project (comprising of the combination of a study protocol with all further required documents, taking into account regulatory and legal environment, planning financial and personal resources) through a structured process that is comprehensive and follows a chronological and logical order 3. Translate and break down a given clinical study protocol and all sponsor’s responsibilities into individual tasks and processes, that can be assigned to involved personal and time points/periods along the time axis of a clinical trial (who has to do what, in which order, when?). 4. Adequately control the quality of these processes during trial conduct 5. Plan, track and control all study related financial flows during a study project 6. Comprehensively manage all tasks involved in performing a clinical trial, as detailed in 2-5, by involving professional study management personal available at the CTUs or comparable organizations
Towards these aims, all CTUs shall delegate professional specialists in clinical trials management to constitute the National Network for Project Management in Clinical Trials (NPMCT). The Network shall allow sponsor investigators and sponsors as well as support organizations of clinical trials to perform tasks 1-6. Towards this goal, NPMCT shall provide a nationally harmonized set of basic tools for trial management in conjunction with a decentral support network provided by study management specialists at each CTU. The network shall perform its operational tasks of study management (task 6) in a decentralized fashion, according to locally established workflows and experiences for the respective tasks at each CTU, however, it shall develop common study support tools that can be applied nationwide. For the construction and maintenance of these study management tools (tasks 1-5) the network shall operate under the lead of one
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Specifically, the following deliverables are anticipated to be provided by the group:
1. Development and introduction of a harmonized calculation tool that incorporates realistic cost and time estimates for all individual tasks involved in clinical study development and conduct, based on full cost estimates. This tool shall allow to derive a realistic, substantiated and justified study budget estimate from the information that is usually given in a study synopsis. It shall assure that study budget estimates that are submitted to industry, as well as to private and national funding agencies (Swiss National Fonds and others) before full project development are substantiated and comprehensive. The tool shall be available to the public through the internet.
2. Development and introduction of a structured process along which a full study protocol and the major logistic preparations (database construction, provision, labelling and distribution of study drug, study contracts, monitoring plan, regulatory documents, quality control) can be developed by a sponsor investigator, under the guidance of and in collaboration with specialized CTU staff
3. Development of a structured process and a respective computer based management tool (Clinical Trial Management System (CTMS)) that allows to initiate, track and control all study related tasks and responsibilities of the sponsor during the conduct of a clinical trial, with the exception of financial flows. This process shall follow a chronological axis, and shall in particular also include all regulatory tasks and timelines, expiry dates of medications and trial insurances, monitoring duties, obligations by GCP, etc. The tool shall allow a sponsor investigator to track and manage a clinical trial of low complexity largely independently from regular CTU support, and shall facilitate the management of complex multicentre trials inside and outside CTUs. The tool shall further allow to assign the respective anticipated tasks to members of the research team in an anticipated time window, so that planning of personal resources during trial conduct can be performed with the help of this tool. The tool shall be available to CTUs and likewise to clinical researchers outside the CTUs. The CTU shall develop and maintain this tool, support its use by investigators, but also use this tool to manage complex trials performed in collaboration with the CTUs.
4. An electronic pharmacovigilance tool shall be developed through which safety data of regulatory relevance (SAE, SUSAR, SADRE) are entered in a common pharmacovigilance database (including assignment of individual case-numbers, coding of SAEs by MedRA, data recording in acc. with ICH- E2B-guideline, etc) that will then allow electronic reporting of SUSARs as xml-files to regulatory and competent authorities in a semi-automated process.
5. A software tool shall be developed that allows anticipating, organizing and tracking all financial flows within a clinical study. The tool shall incorporate and merge all finance-related information from all study-related contracts between the different stakeholders (study sites, grant-agency/financial source, regulatory authorities, other contractors, support organisations, etc) and connect this with the progress of the trial (milestones achieved, trial visits, patient accrual), so that financial flows can be triggered and guided and also deviations for the anticipated budget expectations become obvious as soon as they emerge.
6. Performing study comprehensive management (full study management tasks) of 2-3 clinical studies per FTE, and partial management tasks for 3-5 studies per FTE.
2. Workload and manpower (rough estimate) 2017 to 2020 / Budget Towards these aims, 2.5-3.5 FTE for project management specialists are to be provided at each CTU for operational tasks (deliverable 6), 0.5 FTE each for construction, maintenance and dissemination of study management tools (deliverables 1-5), and 0.5 FTE at the leading house for network coordination. This shall account for a total of 20.5 FTEs for study management in the entire network.
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Enclosure: Budget proposal (Study_Management_Network_Budget.xlsx)
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