Define clinical data management system. write about data collection. PDF

Save (0)



Define clinical data management system. write about data collection ? 5marks

Clinical trial data management involves a set of processes that must be
executed successfully to turn out reliable clinical, control, and administrative data to a
central location such as a coordinating center, a data center, or a resource cente.

clinical data management is a critical phase in clinical research, which leads to generation
of high quality, reliable, and statistically sound data from clinical trails.



Data collection in clinical trials consists of the processes of collecting
reliable clinical, control, and administrative data from the trial’s participating sites with
agreed-upon methods and procedures to record the collected data and send them to a
central location.

Data collection methods are of three major types:

>The first method is pure paper-based systems

With this approach data are collected on paper forms and sent to a
central location. There they are entered into electronic files by the traditional double-key
high-seed data entry method. The resulting electronic files are read into a centralized
database through a data management system using specific computer hardware and

participating site

No computer hardware/software, Complete paper forms and Send hard copies of
completed forms to CC (coordinating centre).

Coordinating site

Computer hardware/software Enter forms into electronic Complete files with
double-key high seed data entry. Process electronic raw data files through a computer

>The second method is electronic-based systems

In which data are entered electronically into a computer system. The system
can be centralized or distributed at participating sites. Electronic-based systems can
utilize various technologies for data entry. Laptops and desktops use modem connections
to transfer remotely collected data to the centralized location, whereas some handheld
and pen-based devices use wireless communications to transfer the data.



In Portable Data Files (PDF)-based systems, collected data are entered on electronic PDF
forms, which are sent on a read-only CD to the centralized location or transferred to a
centralized File Transfer Protocol (FTP) web site.

The newest trend in data collection is direct data entry into a centralized system on the
Internet with web-based data collection systems. This approach is essentially paperless.
All data handling is computerized at both the participating sites and the centralized

Participating site

Computer hardware/software, enter data directly into a computer system.

Coordinating site

Computer hardware/software, Process electronic batch files through a computer

>The third method is hybrid systems

That integrate various methods and techniques for collecting and managing
data. A good example of this approach employs specially designed forms that can be
faxed from the participating sites to a centralized location, where a host computer
equipped with Optical Markup Recognition (OMR) and/or Optical Character Recognition
(OCR) software receives images of the faxed forms.

This software reads and interprets the recorded data, flags data errors, and adds clean
records to the master database. These specially designed forms can also be shipped to the
centralized location to be scanned centrally by a high-speed scanner that is connected to a
computer equipped with OMR or OCR software.

Participating site

Method 1: Complete paper forms, no computer hardware or software. send hard
copies of complete forms to central location.

Method 2: Complete Computer hardware/software e-forms, software Enter
data into a computer system, Send electronic records.

Coordinating site

Computer hard ware/software.

1. Enter forms directly into a centralized computer system.

2. Enter forms into electronic Complete paper forms. raw data files with double key high-



seed and process them through a computer system. Computer hardware/software
Receive electronic files and Process electronic files.