The FDA Guidance of Risk-‐Based Approach to Monitoring as Viewed From CDM Presented By William Gluck, PhD VP, DATATRAK Clinical and ConsulEng Services DATATRAK InternaEonal, Inc.
Agenda InteracEons: Sponsors, Clinical OperaEons and CDM Risk-‐Based Monitoring – Challenges for Sponsors – Challenges for Monitors – Challenges for CDM ImplementaEon – Will there be any aﬀect on data quality or integrity? Will the Risked-‐Based Approach require roles/skill set adjustments?
TradiEonal Paper-‐Based Work-‐Flow Pa#ent Data Database
Data Flow & Monitoring: The Future Centralized CRACRC Database CDM
SupporEng Risked-‐Based Monitoring – Challenges for Sponsors • “The most important tool for ensuring human subject protecEon and high-‐quality data is a well-‐ designed and arEculated protocol.” • Guidance intends to assist sponsors in developing risk-‐based monitoring strategies and plans – Tailored to the speciﬁc human subject protecEon and data integrity risks of the trial – Focuses on criEcal study parameters – Encourages use of a combinaEon of monitoring acEviEes – Encourages greater reliance on centralized monitoring pracEces, where appropriate – it is OK not to do 100% SDV
SupporEng Risked-‐Based Monitoring – Challenges in Clinical OperaEons • Trial speciﬁc • Describe monitoring methods, responsibiliEes, and requirements • Components to consider – DescripEon of monitoring approaches (e.g., Eming, intensity, acEviEes, documentaEon) – Targeted SDV – CommunicaEon of monitoring results – Management of noncompliance – Training and study-‐speciﬁc informaEon – Monitoring plan amendments
SupporEng Risked-‐Based Monitoring – Challenges in CDM • Centralized Monitoring • Quality and Integrity Checks – Increased checks – Increased data collecEon • Technologically Few Challenges • Process/Workﬂow Flow – KEY!
Data Quality/Integrity • IdenEfy criEcal study data and processes, e.g. – Endpoints – Serious Adverse Events – RandomizaEon/ Blinding – Consent – Eligibility Criteria – Risks speciﬁc to protocol design and conduct • Perform and document a risk assessment to idenEfy risks to these criEcal data and processes • Design plans tailored to address important and likely risks idenEﬁed during risk assessment
Role or Skill Set Adjustments Needed to Support Risked-‐Based Monitoring • Sponsors • Site Coordinators/Staﬀ • CRAs/Monitors – Increases in support and technology skills • CDM – Increases in technology process – Increases in training skills
Summary • From the perspecEve of CDM – Need coordinaEon in planning across funcEonal groups/departments – No overwhelming hurdles to implementaEon • Guidance reﬂects acknowledgment that changes to the clinical trial enterprise are OK • Process integraEon is key to eﬃcient use of resources and to add quality
William Gluck, Ph.D. VP, DATATRAK Clinical and ConsulEng Services Datatrak InternaEonal, Inc. Phone: 919-‐651-‐0222 Cell: 919-‐522-‐9681 E-‐Mail: Bill.Gluck@datatrak.net