Clinical data management (CDM) is essential for generating reliable data in clinical trials, ensuring data collection aligns with regulatory standards. The CDM workflow involves multiple stages from data collection to database locking, highlighting the roles of data managers and statisticians in maintaining data quality. Objectives include achieving accuracy and completeness of trial data to support effective statistical analysis and interpretation.

1. WORKFLOW OF CLINICAL DATA MANAGMENT
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Student’s Name: Pawar Manisha
Student’s Qualification :M. pharmacy
Student ID :200/092023

2. INDEX
What is clinical Data Management
Workflow Clinical Data Management
Objectives of CDM
References
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3. What is clinical Data Management
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Clinical data management (CDM) is a critical process in clinical
research, which leads to generation of high-quality, reliable, and
statistically sound data from clinical trials.
Clinical data management ensures collection, integration and
availability of data at appropriate quality and cost.
CDM is the process collecting and managing research data accordance
with regulatory standards to obtained quality information that is complete
and error-free.
.

4. Objectives of CDM:
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To Ensure:
That collected data is complete & accurate so that results are correct.
That trial database is complete, accurate & a true representation of what took
place in trial.
That trial database is sufficiently clean to support statistical analysis & its
subsequent presentation & interpretation.

5. Workflow Clinical Data Management
 The workflow starts when the CDM team generates a case report from
(CRF) and ends when the database lock.
Clinical data management consists of five stages, which span data
collection, archiving, and presentation. ‘
 The data manager executes quality checks and data cleaning throughout
the workflow.
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6. CDM Workflow
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7.  Patient Recorded Data:
• Where the subject is required to record data (e.g. daily symptoms) then a
diary is provided for completion.
• Data management of this data requires a different approach to CRF data as,
for example, it is generally not practical to raise data queries.
• Patient diaries may be developed in either paper or electronic (e Diary)
formats.
Investigator:
Investigator are responsible for supervising the proper handling,
administration ,storage , and destruction of investigational agent .
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8.  laboratory data
• Samples collected during a clinical trial may be sent to a single central
laboratory for analysis.
• The clinical data manager liaises with the central laboratory and agrees
data formats and transfer schedules in Data Transfer Agreement.
• The sample collection date and time may be reconciled against the CRF
to ensure that all samples collected have been analyzed.
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9.  Data manager:
• Data managers are primarily responsible for all data collection and
distribution, making them an integral part of successful clinical data
management.
• They are responsible for ensuring life sciences organizations get
maximum utility out of trial data, from assuring its overall accuracy
and integrity to facilitating easy access and analysis by data analysts.
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10.  Statistician:
• A statistician can contribute to the accuracy and validity of a database by
providing input into the design of both the database structure and data
plausibility checks, and the quality control procedures performed to evaluate
the integrity of a database.
Regulatory Authorities:
• National Designated Authorities (NDAs) are government institutions that serve
as the interface between each country and the Fund.
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11. References
 https://en.wikipedia.org/wiki/Clinical_data_management.
 https://xcelcareer.com/Clinical_data_management-course/
 https://www.scilife.io/golssary/Clinical_data_management
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12. www.clinosol.com
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