CDM's Role in Supporting Risk-Based Monitoring
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The document discusses the challenges of implementing a risk-based monitoring approach for clinical trials as outlined in FDA guidance. It notes that risk-based monitoring requires coordination across sponsors, clinical operations staff, clinical research associates, and clinical data managers. While the centralized data collection and monitoring enabled by clinical data management systems poses few technological challenges, ensuring smooth processes and workflows is key. The guidance acknowledges that changes to the clinical trial process are acceptable if they focus resources on important risks and improve efficiency.
CDM's Role in Supporting Risk-Based Monitoring
- 1. The 油FDA 油Guidance 油of 油Risk-足Based 油 Approach 油to 油Monitoring 油as 油Viewed 油 From 油CDM 油 Presented 油By 油 William 油Gluck, 油PhD 油 VP, 油DATATRAK 油Clinical 油and 油ConsulEng 油Services 油 DATATRAK 油InternaEonal, 油Inc. 油 油 油 油
- 2. Agenda 油 InteracEons: 油Sponsors, 油Clinical 油OperaEons 油and 油CDM 油 Risk-足Based 油Monitoring 油 Challenges 油for 油Sponsors 油 Challenges 油for 油Monitors 油 Challenges 油for 油CDM 油 ImplementaEon 油 油Will 油there 油be 油any 油a鍖ect 油on 油data 油 quality 油or 油integrity? 油 Will 油the 油Risked-足Based 油Approach 油require 油roles/skill 油set 油 adjustments? 油
- 3. TradiEonal 油Paper-足Based 油Work-足Flow 油 Pa#ent 油 Data 油 Database 油 油 油
- 4. Data 油Flow 油& 油Monitoring: 油The 油Future 油 Centralized 油 CRA CRC Database 油 油 CDM
- 5. SupporEng 油Risked-足Based 油Monitoring 油 油 Challenges 油for 油Sponsors 油 ≒ The 油most 油important 油tool 油for 油ensuring 油human 油 subject 油protecEon 油and 油high-足quality 油data 油is 油a 油well-足 designed 油and 油arEculated 油protocol. 油 ≒ Guidance 油intends 油to 油assist 油sponsors 油in 油developing 油 risk-足based 油monitoring 油strategies 油and 油plans 油 Tailored 油to 油the 油speci鍖c 油human 油subject 油protecEon 油and 油data 油 integrity 油risks 油of 油the 油trial 油 Focuses 油on 油criEcal 油study 油parameters 油 Encourages 油use 油of 油a 油combinaEon 油of 油monitoring 油acEviEes 油 Encourages 油greater 油reliance 油on 油centralized 油monitoring 油 pracEces, 油where 油appropriate 油 油it 油is 油OK 油not 油to 油do 油100% 油SDV 油
- 6. SupporEng 油Risked-足Based 油Monitoring 油 油 Challenges 油in 油Clinical 油OperaEons 油 ≒ Trial 油speci鍖c 油 ≒ Describe 油monitoring 油methods, 油responsibiliEes, 油and 油 requirements 油 ≒ Components 油to 油consider 油 DescripEon 油of 油monitoring 油approaches 油(e.g., 油Eming, 油 intensity, 油acEviEes, 油documentaEon) 油 油Targeted 油SDV 油 CommunicaEon 油of 油monitoring 油results 油 Management 油of 油noncompliance 油 Training 油and 油study-足speci鍖c 油informaEon 油 Monitoring 油plan 油amendments 油
- 7. SupporEng 油Risked-足Based 油Monitoring 油 油 Challenges 油in 油CDM 油 ≒ Centralized 油Monitoring 油 ≒ Quality 油and 油Integrity 油Checks 油 Increased 油checks 油 Increased 油data 油collecEon 油 ≒ Technologically 油Few 油Challenges 油 ≒ Process/Work鍖ow 油Flow 油 油KEY! 油 油
- 8. Data 油Quality/Integrity 油 ≒ IdenEfy 油criEcal 油study 油data 油and 油processes, 油e.g. 油 Endpoints 油 Serious 油Adverse 油Events 油 RandomizaEon/ 油Blinding 油 Consent 油 Eligibility 油Criteria 油 Risks 油speci鍖c 油to 油protocol 油design 油and 油conduct 油 ≒ Perform 油and 油document 油a 油risk 油assessment 油to 油idenEfy 油risks 油 to 油these 油criEcal 油data 油and 油processes 油 ≒ Design 油plans 油tailored 油to 油address 油important 油and 油likely 油 risks 油idenE鍖ed 油during 油risk 油assessment 油
- 9. Role 油or 油Skill 油Set 油Adjustments 油Needed 油 to 油Support 油Risked-足Based 油Monitoring 油 ≒ Sponsors 油 ≒ Site 油Coordinators/Sta鍖 油 ≒ CRAs/Monitors 油 Increases 油in 油support 油and 油technology 油skills 油 ≒ CDM 油 Increases 油in 油technology 油process 油 Increases 油in 油training 油skills 油
- 10. Summary 油 ≒ From 油the 油perspecEve 油of 油CDM 油 Need 油coordinaEon 油in 油planning 油across 油funcEonal 油 groups/departments 油 No 油overwhelming 油hurdles 油to 油implementaEon 油 ≒ Guidance 油re鍖ects 油acknowledgment 油that 油 changes 油to 油the 油clinical 油trial 油enterprise 油are 油OK 油 ≒ Process 油integraEon 油is 油key 油to 油e鍖cient 油use 油of 油 resources 油and 油to 油add 油quality 油
- 11. 油 油 William 油Gluck, 油Ph.D. 油 VP, 油DATATRAK 油Clinical 油and 油ConsulEng 油Services 油 Datatrak 油InternaEonal, 油Inc. 油 Phone: 油919-足651-足0222 油 Cell: 油919-足522-足9681 油 E-足Mail: 油Bill.Gluck@datatrak.net 油