CRP 106 Lecture 4 Flashcards
Traditional data management methods
Paper source documents
* Paper Case Report Forms (CRFs)
* Monitor checks to ensure source and CRF match
* Data queries generated – addressed by site
* “Pulls” CRFs from site and returns to Sponsor
* Data entered into database by data management team
* Can also use double data entry to ensure accuracy of the data
EDC in Risk-Based Monitoring
- To most effectively implement an RBM program, study
data must be quickly obtained from study sites - Algorithms assess and compare data across sites
- Real-time assessments of site progress and compliance
EDC Basics
Replaces paper-based CRFs with eCRFs
* System that allows for electronic entry of data from study site
Electronic transmission of data to Sponsor
* Variety of sponsor personnel can remotely access data
Can assess data to ensure integral and clean data
EDC Data Entry Quality Checks
Preprogrammed checks
* Range verification
* Missing data not accepted
* Field verification/variable types
* Only accepts numerical values or categorical variables
* Reduces errors by not allowing inappropriate data types
* On demand reviews
* Quick assessment of data by Sponsor staff
* Queries can be generated and addressed quickly
* Some systems have auto-queries
EDC Data Management Methods
- Paper or electronic source documents
- CRFs can serve as source if appropriately documented in protocol
- Electronic Case Report Forms (eCRFs)
- Completed by site personnel
- Double data entry can be requested to be completed by site personnel
- Oversight by Monitor (either SDV or SDR)
- Data reviewed by data management team and monitors
One or more round of data entry removed - Allows for focused attention to resources to activities that have a
greater impact on ensuring data integrity and participant safety - Greater emphasis on both Investigator’s team and Sponsor
personnel focusing on a partnership on ensuring accurate data
obtained - Historically, some study teams would devote less resources to this task
with expectation that monitor would find issues and correct them.
Title 21 CFR Part 11 Compliance
- A requirement in US jurisdictions and best practice in others
without other explicit requirements - Outlines process of validating electronic records and signatures
- Only required when electronic system will be used exclusively.
- Certain controls required to ensure valid system in place
- Validation occurs to ensure accuracy, reliability, consistency of
performance, ability to discern altered records - Ability to create both electronic and human readable format
- System ensured to maintain records for appropriate record retention
period - Access to system limited to only authorized individuals
- Appropriate audit trials of all activities on system exist
- Written policies and procedures exist regarding use of the electronic
system
Annex 11: Computerised Systems
-Health Canada
-applies to all forms of computerised systems used as part
of a GMP regulated activities
-application should be validated; IT infrastructure should be qualified
-Where a computerised system replaces a manual operation, there
should be nodecrease in product quality, process control or
quality assurance. no increase in the overall risk of
the process.
EDC vs. CTMS
EDC system exclusively concerned with data generated by clinical
trial
* Clinical Trial Management System is like a project management
tool that tracks progress of a clinical trial at each site
* Participant scheduling
* Storing study essential documents ie: approvals, etc
* Managing study workflow between all study components eg: Investigator,
Coordinators, Pharmacists, etc
* Financial Management of sites <– major role
* CTMS may interface with an EDC system but does a different task
Risk-Based Approaches
-risk-based monitoring uses
technology, data integration and analytics to allow assess
and detect trends in large amounts of aggregated data
Ideal Characteristics of RBM System
Planning
-Ability to apply a pre-determined risk algorithm based on
risk level identified (low/medium/high)
* Ability to scan forms and extract data (eg: protocol, CRFs,
etc)
Ideal Characteristics of RBM System
Data Capture
Accommodate direct digital data capture
Ideal Characteristics of RBM System
Data Aggregation
- Ability to access and aggregate data from different
sites/systems - Able to standardize data to enable analytics
- Flexible platform that allows for data from multiple
sources and formats to be aggregated - Near real-time data access
Ideal Characteristics of RBM System
Analytics
- Analytics can be applied to aggregated data
- Can assess data for outliers and trends
- Ability to set thresholds with respect to identified outliers
- Ability to indicate potential quality risk
- Automated reporting
Ideal Characteristics of RBM System
Reporting and Visualization
- Can report on outliers and trends observed
- Reports can be generated by issues identified
- Ability to visual observe outliers and trends
- Can have role specific views (study manager, monitor, etc)
- Customized dashboards and viewing parameters
Variable Assessment
- How variables are to be assessed should be determined during
setup - Determine whether comparisons occur across:
- Program (ie: all studies investigating the IP)
- Protocol (ie: all study sites implementing the protocol)
- Country
- This plan should be determined and documented within the
Integrated Quality and Risk Management Plan
