1. Write about the clinical data management system ?
Clinical data management is “all the disciplines related to managing clinical
data as a valuable resource, including acquisition, database administration, storage,
backup, security, and quality assurance”.
Clinical data management is the work that involves the planning, development,
implementation, and administration of systems for the acquisition, storage, and retrieval
of data.
Data management is the process of accumulating collected data into a master database in
a central location while ensuring their security, validity, and completeness by generating
quality assurance reports to monitor the progress of the trial.
Clinical trial data management involves a set of processes that must be executed
successfully to turn out reliable clinical, control, and administrative data to a central
location such as a coordinating center, a data center, or a resource cente.
Clinical data management is a critical phase in clinical research, which leads to
generation of high quality, reliable, and statistically sound data from clinical trails. this
helps to produce a drastic reduction in time from drug development to marketing.
CDM encompasses the entry, verification, validation, and quality control of data gathered
during the conduct of clinical trail.
◼ Objectives of Clinical data management system
1. The integrity and quality of data being transferred from trail subjects to a database
system
2. That the collected data is complete and accurate so that results are correct
3. That trail database is complete and accurate, and a true representation of what took
palce in trail
4. That trail database is sufficiently clean to support statistical analysis, and its
subsequent presentation and interpretation.
5. The ultimate goal of CDM is to assure that data support conclusion drawn from
research. Achieving this goal protects public health and confidence in marketed
therapeutics.
www.DuloMix.com
◼ The various key members involved in data management are
1. Clinical Data Manager
2. Database Administartor
3. Database Programmer
4. Clinical Data Coordinator
5. Clinical Data Associate
Regulatory agencies is dependent upon a trust that clinical trails data presented are of
sufficient integrity to ensure confidence in results and conclusions presented by pharma
company and it is important to obtaining that trust in adherence to quality standards and
practices.
Some data collection and management systems have been developed to enable data
collection and management of several trials being conducted simultaneously using a
shared system. This presents security issues, including providing participating sites with
secure access to data associated with their trial while restricting them from accessing data
of other sites or trials and providing participating sites, the coordinating center, and other
participating entities with the appropriate access to reports and queries. These security
challenges are met by using secured socket layer technology (SSL).
Clinical data management system (CDMS)
The clinical trail data gathered at the investigator site in the CRF (clinical report forms),
are stored in the CDMS and this system employs various means to verify the data to
reduce possibility of error due to human entry.
Types of Clinical data management system
1. Paper based system
2. Electronic data capturing system
Paper based system
Data is entered to CDMS from CRF and this process is time consuming and it is
inexpensive.
www.DuloMix.com
Electronic data capturing system
Data is directly upload to CDMS by investigator and it is a time saving process and
also expensive. Electronic alert send to the site if there is any problem.
> Once the data are uploaded by site then data validation is done by data validation team
if there is any discrepancy then alert is send to the site to resolve it.
◼ Types of Functions provided by clinical data management / Responsibilities
of CDM
STUDY SETUP
1. Case report forms (CRFs) design and development
2. Database design build and testing
3. Edit checks preparations and testing
STUDY CONDUCT
1. Data entry
2. Discrepancy management
3. Data coding
4. Data review
5. SAE ( serious adverse events ) Reconcillation
6. Data transfer
STUDY CLOSE OUT
1. SAE ( serious adverse events ) Reconcillation
2. Quality control
3. Database lock
4. Electronic archival
5. Database transfer
www.DuloMix.com
➢ CRF DESIGN
A representation of the study as outlined in the protocol is made ( including CRF
completion guidelines if necessary ). therefore a final protocol needs to be available
before this activity can be initiated.
CRF design usually takes about 3 rounds
⚫ First draft ( rough without detail about correct content )
⚫ Second draft ( as good as we can get it )
⚫ Final version ( we need input from sponsors to correct draft versions and to
approve final version).
➢ DATA BASE DESIGN AND TESTING
Data from a clinical trial will be collected and stored in the CDMS, a database is
a simply structured set of data.
Testing is always performed in a secure, non study environment (test site).
➢ DATA ENTRY
Data entry is a process of entering of data from case report to CDMS.
1. Single data entry
2. Double data entry
➢ DISCREPANCY MANAGEMENT
Discrepancy management is a process of cleaning subject data in the clinical data
management system. It includes manual checks and programmed checks.
➢ MEDICAL CODING / DATA CODING
The medical coding for study is done as per the project specific protocol
requirements. The dictionaries used for a study are:
MedDRA and WHODD ( world health organization drug dictionary).
➢ SAE RECONCILIATION
This is the comparison of key safety data variables between CDMS and
sponsor. This is performed to ensure that events residing in both systems are consistent.
www.DuloMix.com
➢ DATABASE LOCK
The database lock for study is done to ensure no manipulation of study data during
the final analysis. Data base lock is done once all the data management activities are
completed.
IMPORTANCE OF CDM
1.It provides data and database in a usable format in a timely manner
2.It ensures clean data and ready to lock database.
www.DuloMix.com