clinical Trial Data Management .pdf

Pawan Dhamala
Computer Aided Drug Design

1. By: Pawan Dhamala
Sub: Computer Aided Drug Development
M.Pharmacy 2
nd
Sem(Pharmaceutics)

CLINICAL DATA MANAGEMENT

2. Data Management

Definition of data management. “all the disciplines related to managing data as a
valuable resource, including acquisition, database administration, storage, backup,
security, and quality assurance”
OR
A layperson’s definition of 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.

Types of Data management systems
Pure paper-based
Electronic-based
Hybrid paper-based

1 Pure paper-based system
Pure paper-based data collection systems have used in clinical trials. they are
being used by many contract research organizations (CROs) because of financial
constraints that prevent them from investing in newer technology. Other CROs
consider the paper-based data collection method to be the safest and most reliable
approach to data collection.

a)Suitability and Hardware/Software Requirements
Pure paper-based data collection systems are most suitable for small studies.
software needed at the participating sites because data are recorded manually on
paper forms that are transferred to the centralized .hardware and software are
needed at the centralized location for the data management system.
The most commonly used platforms include Open VMS, Unix, or PC, and one of
the most widely used software packages is SAS®

b) Design and Implementation
Pure paper-based data collection systems use paper forms that can be designed
with any graphical or software such as Adobe PageMaker, Microsoft Word, or MS
PowerPoint . The advantage of this system is a certain degree of flexibility in that
even after data collection begins minor changes to the forms.
The repeated for every record that contains identifying information, such as site
code, patient ID, visit or encounter number, date, form number, and record
number.

3. c) Managing Data
Pure paper-based data collection systems are inefficient in the large data editing.
Person at the central location must perform visual inspections of forms, compare
them against the shipping log, convey submission errors and omissions to the
participating sites.




2 ELECTRONIC-BASED SYSTEMS
Electronic-based data collection and management systems have revolutionized data
collection and management. The advantages of system over pure paper based
method is provide cleaner data faster, thus significantly reducing query rates and
eliminating double data entry.
 It provide up-to-date interim progress reports.
 it provide for quick access of up-to-date data for feedback to the appropriate
stakeholders.
 Electronic-based data collection and management systems rely heavily on
computer hardware and software at both the participating sites and the
coordinating centers.

a)Centralized Systems
Centralized systems reside at a central location and are accessed through a local
area network (LAN), a wide area network (WAN), or a virtual private network
(VPN).The user logs into the system with valid user id and password credentials
from any computer connected to the network. The access of the user to the
centralized database enables direct entry of the data into a centralized database.

b) Distributed Systems
In distributed systems participating site must be equipped with a desktop or a
laptop computer loaded with the distributed data collection system software to
collect and enter data locally.
Collected data are transferred periodically to the central location as files saved on
storage devices, via phone modems, by FTP (File Transfer Protocol).

c) Wireless Systems wireless computer systems has gain popularity in data
collection for clinical trials.
 They have also been used for mobile interviewing.
 Bedside data collection.
 In patient-directed data entry.

4.  Laptops and desktops, hand-held computers have much smaller screens.
They have limited memory space and computational capability.

d) PDF-Based Systems
This method of data collection uses Portable Document Format (PDF) Form
Paper copies of the PDF forms may be used as an intermediate data collection.
Electronic versions are completed at each site with Adobe Reader software.
Python has been used to extract data elements from submitted PDF files and create
automated analysis data


e) Web-Based Systems
Web-Based Systems With the increased acceptance of the Internet and the huge
innovations in web development tools, web-based data collection and management
systems have become the choice of many CROs because of their capability for
collecting clinical trial data in real time and disseminating critical clinical trial
information to the participating sites and various oversight committees.


f) Direct Systems
Direct data collection (DDC) as an alternative to remote data capture (RDC). In
this approach most of the required clinical data are acquired directly from existing
patient record systems such as MRI machines, ECG, EEG, TTM, laboratories.

3 HYBRID SYSTEMS
Hybrid systems are systems that employ various strategies to collect. Additional
data may be downloaded from centralized databases.

a) Paper Data Collection with Centralized Interactive Data Entry
Data are collected on paper forms and shipped to the coordinating center where
data coordinators enters them directly into a centralized data management system
The data coordinator visually checks received forms as in pure paper-based DMS.
The first data coordinator checks and rectifies these discrepancies
A second data coordinator reviews the fully marked entered forms and compares
the entries against the paper forms, flagging any discrepancies.

b) Paper Data Collection with Centralized Batch Data Entry.
This data are collected on paper forms. Completed forms are mailed to the
coordinating center, where they go through visual inspections. The data which pass
the visual inspections are sent to the data entry department, where they are entered
with high-speed double-key data entry.

5. c) Paper Data Collection with Direct Data Transfer to Centralized DMS
Approach is the use of facsimile (fax) transmission to a dedicated computer
equipped with software such Teleform® software that can be customized to fit the
needs of the clinical trial. Scannable forms are designed with specialized software
and distributed to the participating sites to complete. Advantages of this
technology include the speed at which forms can be sent to a coordinating center
and the fact that fax communications are very much standardized.

d)Integration of Distributed Systems with Remote Servers over the Internet
In web-based application models that use web browsers to display information
sent by the application server, the largest part of the data management applications
reside on the server.
important limitations:
(1) All participating sites must have an Internet connection;
(2) it requires the ability to constantly be connected to the Internet;
(3) the Internet connection makes it less portable;
(4) it generates a large amount of network traffic;
(5) it creates difficult issues of data validation and data integrity; and
(6) there can be browser incompatibilities.