Evolving Role of the Data Manager

Transcription

1 07 November 2016 Evolving Role of the Data Manager

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3 Evolution of the Data Manager Role Mobility Early 90 s We all simply did it OUR way! No formal measure of data managers' knowledge and know-how CDISC 21 CFR Part 11 Introduced 2000 Survived Y2K after all! edc Auto-Queries Central Monitoring Big Data Analytics RBM Statistical Monitoring Globalization & Outsourcing Transformations are enabling dramatic improvements in Clinical Trial Processes and consequently changing many of the roles, especially the Data Manager 3

4 What is Central Monitoring? Remote evaluation - FDA carried out by sponsor personnel or representatives (e.g. clinical monitors, data management personnel, or statisticians) at a location other than the sites at which the clinical investigation is being conducted. Review of data collected for identification of unusual patterns - EMA Document review, data review and analysis performed remotely from the investigator site by the sponsor to examine the data collected in order to check compliance, identify unusual data patterns, deviations from protocol or missing or invalid data. - EMA Remote data review of data collected - ICH E6 (R2) 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

5 Common Agreement Tasks conducted remotely, often with the aid of technology Review for missing or inconsistent data Develop data checks for ranges, outliers, completeness, protocol deviations, invalid data and unusual data patterns Sounds Familiar? Typical checks covered by the processes and technologies of a Data Management function. Central function or rather off site - Rarely would a Data Manager set foot from their office and almost never to site. 5

6 Today Tomorrow 1. Design EDC / CRFs internally 2. Look for data inconsistencies and initiate query resolution 3. Focus primarily on designing edit checks 4. Only interface with internal CRAs (and Project Managers) 1. Collaboratively develop esource (and EMR) approaches to leverage how sites work day-to-day 2. Explore data for patterns and outliers to identify areas of interest (e.g., safety, efficacy, data quality) 3. Support development of KRIs and algorithms 4. Interact with biostatistics, centralized monitors, CRAs and investigator sites 5. Recommend proactive risk avoidance and mitigation strategies 6

7 How to work together to innovate and progress how clinical trials are conducted onsite? Site Staff / Investigator CRAs / On-site Monitors Perform higher-order tasks Analyze root causes of errors made by sites Develop error-specific CAPAs Assist sites with devising and implementing new procedures to prevent recurring errors Data Manager / Central Data Monitor Near real-time review of study data to monitor data quality, patient safety as well as relevant risks (via alerts and reports) Support development of prospective risk signals (RACT) Provide central and on-site monitors information needed to anticipate, mitigate and resolve risk issues Provide narratives that support onsite monitoring activity. 7

8 Responsibilities of the Central Monitor Patient Data Monitoring Risk Monitoring Assess patient and site data to ensure high quality and patient safety Monitor risks and data trends related to quality, safety, efficacy Facilitate early identification of risk/issue(s) Generate risk alerts to study managers, on-site monitors/cras), biostatisticians, medical monitors Track risk/issue(s) until resolution Study Team Support Track site performance and support corrective actions Act as a single point of contact for study teams for timely communication of site and study information Keep on-site monitors well-equipped with risk/issue(s) analyses to plan timely, efficient and focused site interventions Document centralized monitoring activities: e.g., risk/issue(s) findings, escalation, tracking and resolution during study conduct 8

9 What are the Needed Qualifications? Extensive Data Management experience Understanding of key on-site and centralized monitoring activities Therapeutic Area knowledge Overall Clinical Trial management process knowledge Understanding of the protocol, study associated risks and their significance Critical thinking and analytical skills 9

10 How to build and acquire needed capabilities? 10

11 Use a Consultative Change Management Approach to Transition from: Current State to Future State Data Management Team Leaders will need to proactively transition team members to new roles/capabilities initiate needed change, rather than react Identify Current State Define Future State Conduct a Gap Analysis Understand the current skills and experience of your team Main Activities Create a Competency Model by defining the experience and skills that are essential for future success Assess the experience and skills of your team members relative to the Future State Build an Upskilling Plan Define and Implement Strategies to lead the team from the Current State to the Future State 11

12 Leadership Must Set Clear Expectations Hold team accountable Provide needed change management support Develop-update Competency Model (CM) Training & Performance Management Job shadowing and secondments into new roles Review and optimize business processes Recruit external talent Attend conferences and webinars, author white papers, participate in industry working groups 12

13 Thank you