Week 5 CDM Session 1

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U18BTT7002 PRECLINICAL AND

CLINICAL REGULATORY AFFAIRS


W5: CLINICAL DATA MANAGEMENT
Mrs. Veerabhuvaneshwari Veerichetty

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

• End result for the CDM:


– A study database - accurate, secure, reliable and ready for analysis.
– Timeline from data collection to analysis

• 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.

The objectives of good clinical data management are to ensure:


•That the trial database is complete, accurate and a true representation of
what took place in the trial
•That the trial database is sufficiently clean to support the statistical
analysis and its interpretation
CDM process - activities:
- Data management plan (DMP) development
- Study setup
- Training
- Data collection

INTRODUCTION TO CLINICAL DATA MANAGEMENT

https://www.youtube.com/watch?v=hpWSZ03fOy0
ROLES AND RESPONSIBILITIES IN CDM
TOOLS FOR CDM

Commonly used CDM tools are RAVE, ORACLE CLINICAL, CLINTRIAL,


MACRO and eClinical Suite.

RAVE is a cloud-based clinical data management system used to


electronically capture, manage and report clinical research data.
REGULATIONS, GUIDELINES AND STANDARDS IN CDM

Electronic records need to comply with a code of federal regulations (CFR),


Title 21 CFR Part 11. Title 21 CFR Part 11, a constituent of the code of federal
regulations is defined as the criteria under which electronic records and
electronic signatures (ERES) are considered trustworthy, reliable and
equivalent to paper records.

Clinical data interchange standards consortium (CDISC) is global, open,


multidisciplinary, non-profit organization that has established standards to
support the acquisition, exchange, submission and archival of clinical
research data. The two most important standards established by CDISC are
study data tabulation model implementation guide for human clinical trials
(SDTMIG) and the clinical data acquisition standards harmonization
(CDASH) standards.
CDASH

The Clinical Data Acquisition Standards Harmonization


(CDASH) collated input from a spectrum of clinical trialists,
including data managers, statisticians, investigators, monitors
and study coordinators, and developed a set of consensus-
based data collection standards. CDASH created conventions
for individual data collection fields and sets out standards for
element name, definition, and metadata.
Clinical Data Interchange Standards Consortium (CDISC)

CDISC is a non-profit organization, whose mission is "to develop


and support global, platform-independent data standards that
enable information system interoperability to improve medical
research and related areas of healthcare".

CDISC has developed the Study Data Tabulation Model


(SDTM) which is intended for standardisation of data
submission to the US FDA.
GOOD DATA MANAGEMENT PRACTICE -GDMP
Data Management Plan - DMP

• 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

• database structure specifications


• description of the database building and testing procedures
• a list of SOPs for the data management processes (e.g. data entry and
data validation) which will be used to ensure consistency
• a description of how the data will be reviewed (e.g. data queries and
resolution processes) and information about how changes in data will be
managed
• details of how the data will be coded, analysed and archived

The plan should also describe the roles and responsibilities of all staff
involved in gathering or handling the study data.
Study setup

Study setup includes:

• Case report form (CRF) design


• CRF completion guidelines
• Trial database (DB) setup
• Validation checks
Case Report Form Design
A CRF (also known as a data collection form) turns the protocol
into the data capture system. The CRF is essential in obtaining
accurate and complete study data.

The1996 International Conference on Harmonization Principles of


Good Clinical Practice (ICH GCP) guidelines define a CRF as a
printed, optical, or electronic document that ‘is designed to
record all of the protocol required information to be reported to
the sponsor on each study subject’.
ELECTRONIC DATA CAPTURE
EDC- Electronic Data Capture Systems

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

Tomorrow, will create a hypothetical CRF using RedCap tool


Check and login in (If you are not able to login let me know)
(Navigate to the REDCap site: https://www.datacourse.org ;
Click on the Log In Using Coursera button)
SUMMARY
CDM PROCESS STEPS

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

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