Week 5 CDM Session 1
Week 5 CDM Session 1
Week 5 CDM Session 1
Department of Biotechnology
Overview of this Lecture
• What data management is and the purpose of a data management plan
• Roles and responsibilities
• The factors to be considered in the quality of data and case report form
• Regulatory Guidelines
• CRF and Electronic Data Capture
• Good CDM - delivery of the quality data on-time and within the
trial budget
Clinical Data Management (CDM)
Clinical Data Management (CDM) is the process of collection, cleaning,
and management of subject data in compliance with regulatory standards.
The primary objective of CDM processes is to provide high-quality data by
keeping the number of errors and missing data as low as possible for data
analysis.
https://www.youtube.com/watch?v=hpWSZ03fOy0
ROLES AND RESPONSIBILITIES IN CDM
TOOLS FOR CDM
• database entry and design, data tracking methods and guidelines, SAE reporting and
narration, SAE reconciliation, discrepancy management, quality control and final
database locking guidelines.
• After the DMP has been developed, comes the designing of the database. An important aspect
of data base designing is to validate the system which ensures data security and accuracy. The
components of the study which are taken into consideration during this phase are sites,
investigators, patients, objectives etc. The data entered by the user in the front end i.e. on
their computer screens gets stored in the database.
• The data collection can be done by using case report forms which can be either in paper or
electronic format.
• The tracking of the CRFs is monitored by a Clinical Research Associate or the site monitor for
completion and accuracy. In case of any inaccurate or nonsensical data entered, a “query” is
generated during the quality check procedure in data management. The resolution of these
queries is known as “Discrepancy Management”. This is one of the most critical activities in
the CDM process so it is advised to handle this particular aspect with utmost care.
• The final step in a CDM process is Database Locking wherein all data management activity
should be completed prior to this. Once the database is locked, no further changes can be
made to it. The data is then extracted for statistical analysis.
The Data Management Plan
The plan should also describe the roles and responsibilities of all staff
involved in gathering or handling the study data.
Study setup
https://www.youtube.com/watch?v=TyTt66Wz6h8&list=PLN7iY0sJLQGDIaQwsN5uzqt_0hV53qOZX&index=1
https://www.youtube.com/watch?v=iBTB9PeuSGQ&list=PLN7iY0sJLQGDIaQwsN5uzqt_0hV53qOZX&index=2
https://www.youtube.com/watch?v=iBTB9PeuSGQ&list=PLN7iY0sJLQGDIaQwsN5uzqt_0hV53qOZX&index=2
1. Database Designing
2. Data collection
3. CRF tracking
4. Data entry
5. Data Validation
6. Discrepancy Management
7. Medical Coding
8. Database Locking
9. Statistical Analysis