Clinical Data Management: Best Practices and Key Considerations

Welcome
CLINICAL DATA MANAGEMENT: BEST
PRACTICES AND KEY CONSIDERATIONS
Chetana Menda
Pharm. D
084/052023
10/18/2022
www.clinosol.com | follow us on social media
@clinosolresearch
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Index
• What is Clinical Data Management (CDM)?
• Stages of Clinical Data Management.
• Clinical Data Management Process.
• Phases in Clinical Data Management.
• Objectives of CDM.
• Conclusion.
• References.
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What is Clinical Data Management (CDM)?
 Clinical Data Management (CDM) is the part of clinical trail management that deals specifically with
information that comes out of the trails.
 CDM is a critical phase of clinical research, which leads to the generation of high quality, reliable and
statistically sound data from clinical trials.
 Clinical Data Management includes the entry, verification, validation and quality control of data
gathered during the conduct of a clinical trial.
 CDM is involved in all aspects of processing the clinical data. It involves working with a range of
computer applications, database systems to support collection, cleaning and management of clinical trial
data.
 Review and approval of new drugs by Regulatory Boards is dependent upon the integrity off clinical
trial data which is the core purpose of CDM.
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Stages Of Clinical Data Management
Data Management begins with the
• Development of the data management plan and
• Design of the data capture instrument (e.g. the case report form), continues with
• Data collection and regular quality control procedures,
• The database cleaning,
• Locking and ends with analysis, archiving and write-up.
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CLNICAL DATA MANAGEMENT PROCESS
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Phases in Clinical Data Management
STARTUP PHASE:
Startup phase consists of activities like Case Report Form (CRF) creation and designing,
Database designing and testing, Edit checks preparation and User Acceptance Testing (UAT) along
with document preparation such as data management plan, CRF completion guidelines, data entry
guidelines and data validation plan.
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PHASES OF
CDM
CONDUCT CLOSEOUT
STARTUP

1. CRF Designing:
• CRF designing have two types, Paper CRF and eCRF.
• Paper CRF will be prepared by CRF designer and send to site for review. Upon confirmation, Paper CRF
will be designed in electronic data capture (EDC) for data management (DM) team for data capture.
• eCRF will be designed directly in the EDC by EDC Tech lead and CRF designer and site will have EDC
access to review it.
2. Database Designing:
• Database designing is done by Database Programmer and EDC designer.
• Key points like Field length, dynamic forms, acceptable range, access level management will be designed
as per the study requirement.
• CRF annotation plays a vital role in assigning the variables for each field.
• After Database designing is successful, DB Programmer will implement the condition as per Data
Validation Specification (DVS) for queries to fire for out of range conditions.
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3. Edit Checks Preparation:
Edit checks are created by a database designer and embedded into eCRFs to automatically
compare inputs against numerical and logical criteria. This prevents unlikely values from appearing in the
document.
4. User Acceptance Testing(UAT):
User Acceptance Testing (UAT) is the process where edit checks with specific conditions as per
protocol is created by the Clinical Data Analyst (CDA) and Clinical Database Programmer (CDP) creates
those condition in the database to fire query for the conditions.
Data validation Specification (DVS) is the document where CDA writes all the edit checks and
CDP modifies the EDC as per DVS.
Ex: As per protocol, Age Inclusion is 18 to 55 years: When the captured as below 18 or above 55, Query
fires with Query text as “ As per protocol, Age Inclusion is 18 to 55 years, please confirm”.
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CONDUCT PHASE:
Conduct phase is the longest and most critical phase where Data capture, Data Cleaning, Data
reconciliation, Medical Coding and Data Validation takes place with regular evaluation of data known as
Interim Analysis along with documentations such as Query Management Form, Revision Request Form, Post
Production Changes.
1. Data Collection:
In e-CRF, the clinical site will directly capture the data in EDC and confirm Source Data Verification
which is the latest most welcoming method by sponsors to avoid discrepancies.
2. Discrepancy Management:
Query Management is the major process in Discrepancy Management which helps to clean the data
by system generated queries or manual queries. The four types of queries are: Open query, Answered query,
Closed query, and Cancelled query.
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Open Query are queries which is open to DM or site which is not answered yet.
Answered Query are queries which is either answered by DM or site but not closed yet.
Closed Query are queries which are closed as per the confirmation from either DM team or clinical site.
Cancelled Query are queries which is cancelled by the DM team which has many reasons such as
misfiring query, query not required, or query raised manually by mistake.
3. Medical Coding:
The medical coding for the study is done as per the project specific protocol requirement. The
dictionaries used for a study are:
Adverse Events: MedDRA (Medical Dictionary for Regulatory Authorities)
Medications: WHODD (World Health Organization- Drug Dictionary)
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4. Data Reconciliation:
CDM data reconciliation is a data review process that compares unique identifiers in the EDC data
such as subject number, visit, nominal time point, collection dates and collection times with the same data
points in the electronic external data source datasets.
CLOSE OUT PHASE:
Close out phase is the success phases for Data Managers where all the clean data are frozen and
locked. After the confirmation of locking all the data, it will be only in Read only mode. Finally, the Database
will be locked, and all the documents are archived.
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Database Lock:
Database lock is the final process in Clinical Data Management . After all the queries are actioned
and all outstanding issues are resolved, the Final Clean Data is frozen either manually or by script to ensure the
data is not edited further which means post freezing, data will be in Read only mode. Once all the data are
frozen, The Database lock approval is sent to stakeholder and sponsors. The database will be successfully
locked.
Post Database lock, the data will be extracted by Statistical programmers for analysis and Data
management team completes all further documentation and proceed for archival.
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Objectives Of CDM:
CDM is a vital vehicle in Clinical trials to ensure:
 The integrity and quality of data being transferred from trial subjects to a database system.
 That the collected data is complete and accurate so the results are correct.
 That the trial database is complete and accurate, and a true representation of what took place in trial.
 That the trial database is sufficiently clean to support statistical analysis, and its subsequent presentation
and interpretation.
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Conclusion
Clinical Data Management helps the pharmaceutical companies to speed up the drug
development process by providing clean, high quality and reliable data which helps to submit relevant
documents with strong support for the drug to regulatory authorities.
“The mission of CDM is Consistency, Accuracy, Validity and Archiving the Data”.
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References
1. https://www.slideshare.net/KatalystHLS/clinical-data-management-process-
overviewkatalyst-hls
2. https://www.slideshare.net/finenessinstitute/understanding-clinical-data-management
3. https://www.smartsheet.com/content/clinical-trial-data-management-guide
4. https://ijshr.com/IJSHR_Vol.4_Issue.4_Oct2019/IJSHR0013.pdf
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Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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