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CDM > Page1 | Page 2
Clinical Data Management (CDM) is the management of Clinical trial data from its collection to its extraction for analysis.
To ensure the quality of clinical trial data, this complex process of clinical
data management has evolved over time.
What is done to perform
management of Clinical Data ?
This is what is done in general, however study specific or centre specific modifications are possible.
 Case Report Form (CRF) Design.
Data Collection / capture - Entry of CRF data
(into a clinical data management system [CDMS])
Capturing foreign data - Merging of non-CRF data e.g. Laboratory data of the trial coming from different source other than trial sites. Batch loading is preferred than doing manual entries.
Systems & processes designed to identify bad data. Systems include the validated hardware and software involved in the job.
Identify discrepancies in the data - Determine protocol violators
Generate & track CRF's & resolve queries (Query management).
Interact with Site /Team personnel to resolve data issues
Medical Coding using standard Medical dictionaries for Medications (ConMed) and Adverse effects (AE).
Generate reports from the data as per sponsor requirements
Medical review of the Data.
Writing derivation rules for the SAS programmers.
Sorting and archival of the data for a specified time.
The Clinical Data Management team works closely with
Clinical trial Sponsor, trial sites and statisticians to ensure that the data obtained is as per the expectation of the trial operational and Statistical Analysis protocols
(SAP). The Clinical trial data is
captured into a Clinical Data Management system (CDMS), cleaned, reviewed and extracted to be provided to the Statisticians and Scientists for review and analysis (Eventually required for regulatory submission).
The role of CDM in clinical trials is still evolving with the emerging technology.
Currently it is the most IT driven process in the business of drug development. It is the practice that matters and
major part of the success of any clinical trial project lies in how robust are the processes and infrastructure of CDM facility.
Paper Trial or EDC ?
The clinical trail data is traditionally collected in a set of paper forms
called as Case Report Forms. Each subjects (trial participant) data is entered in a
set of separate CRF's. Part of CRF page sample is shown below :
Sample Case Report Form
As seen in the CRF sample Study code,
Randomisation no., subject initial, age, sex, height etc. and others hundreds of
data is entered in the Paper CRF at the trial site. These CRF's are then sent to
a CDM facility and data is manually entered into a Clinical Data Management
Application/System. This traditional approach is loosely referred to as Paper
CDM. When Data is entered directly in electronic forms at the sites and the data
gets stored in a central repository then it is referred to as EDC or Electronic
data capture. The decisions about whether data will be collected on paper forms
or whether there will be electronic data collection is based on the number of
sites participating, the type of study, the kinds of data being collected, and
the available resources.
Some more details :
All of the above processes require documentation
in a Data Management Plan. Data Management Plan (DMP) is a crucial document and
serves as a master document for processes and quality of the Clinical Data
Management of a Clinical Trial.
Clinical Data Management Steps (brief) : The Steps in CDM are available here
The CDM system (CDMS)/ Application (CDMA) (Computer Systems used to perform Data Management) :
The Computer Systems or Softwares which allow Data capture, Data cleaning, Data reporting, Data extraction and data storage in a backend Database are called Clinical Data Management systems (CDMS). Database may be Oracle, MySQL, Access, SAS datasets, indexed data (legacy data) or even Microsoft Excel spreadsheets.
Computer System Validation : To be added soon
Few CDM Systems
Very few products are accepted because people are reluctant to embrace new products. Interestingly FDA and other regulatory guidelines are misinterpreted.
Oracle Clinical : Oracle Corp.
Clintrial : Phase Forward
DMSys : SigmaSoft International
PhEdit : SAS
Rave : Medidata
Acceliant : Megasoft
Open Clinica : Akaaza Research | Click here
for Install instructions of OpenClinica for Linux
What it takes ? :
1. Selection of the System (s) and architecture.
2. Selection of the Database and data structure, data archival and data safety.
3. Validation of the system as per industry norms which involves using test cases.
4. Setting up robust infrastructure i.e. Standard procedures (SOP), hardware, supporting software(s), experts
5. Setting up Standard Operating procedures (SOP) , because the whole business of drug development is much process oriented.
6. Setting up the Procedures to handle study specific changes since every study is different. Sometimes the different time zones of the involved parties could create chaos.
7. QA/QC - Quality checks.
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