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DM Process

The document discusses the process of data management for clinical trials. It involves designing case report forms (CRFs), developing an electronic or paper-based database to store trial data, creating a validation checklist to define required data checks, and testing the database. CRF design takes several rounds of drafts and sponsor approval to finalize. The database is tested using test subjects and checks to ensure proper data entry and validation before study data is entered into the production database.

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Viji Lakshmi
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© © All Rights Reserved
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Download as PPTX, PDF, TXT or read online on Scribd
26 views

DM Process

The document discusses the process of data management for clinical trials. It involves designing case report forms (CRFs), developing an electronic or paper-based database to store trial data, creating a validation checklist to define required data checks, and testing the database. CRF design takes several rounds of drafts and sponsor approval to finalize. The database is tested using test subjects and checks to ensure proper data entry and validation before study data is entered into the production database.

Uploaded by

Viji Lakshmi
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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DATA MANAGEMENT

PROCESS

CRF Design/Review
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
three rounds: First draft (rough without detail but correct
content), second draft (as good as we can get it) and final
version. We need input from our sponsor to correct draft
versions and to approve the final version.
Traditional Paper Based Case Report Forms
e-CRF (Electronic Case Report Form)- Study information
directly entered into computer.
e-CRF is prepared by using:
OPEN CLINICA
ORACLE CLINICAL
CLINTRIAL

Data Base Design


Data from a clinical trial
will be collected and
stored in some kind of
computer system.
A database is simply a
structured set of data.
A collection of rows and
columns.
--Excel Spreadsheet
--Oracle application

Validation Checklist:
Validation Checklist describes in detail which data shall
be checked and queried if necessary. The programming
of the checks occurs according to this checklist. Before
the programming starts, the sponsor will be asked to
give approval of this Validation Checklist.
Test subjects are entered in the database to test the entry
screens and the programming. The exact number of test
subjects is not standard, but every check has to pass
and fail (negative and positive proof) at least once.

Database set up and testing


Database setup and testing are always performed in a
secure, non study data environment.
Only when a database has been reviewed and fully
tested, will it be set in production, a separate
environment where only study data will be entered.
Changes in structure or programming will always
first be performed and tested in the non study data
environment before they are made effective in the
production database.

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