Computer Capture is a process to collect the data in electronic form. It is very important process in Clinical Data Management, Clinical Research Industry.
2. “Computer Capture”
O “Any process for converting & transferring
information into a form that can be handled
by a computer”
O Ex.- Study reports, Forms, Documents,
letters, invoices etc.
O These documents can be sent & received in
a number of ways such as : Fax, Post,
Email, Voice, SMS, Web form, external
system.
3. O The process of converting & transferring info. is
given in 21 CFR part 11 , CDISC precisely for
regulatory need.
O Method of data capture, due consideration of the
origins of the documents(s) that need to be
captured must happen, to see if the documents
are available in their original electronic format
which, has the potential to massively increase
data capture accuracy and remove the need for
printing and scanning. Methods of capture from
documents in electronic format are identified
below.
4. O Original documents, to determine if the document or
form can be updated to improve the capture/recognition
process and method.
The Reports
There are two types of report usually generated
in the study…
O One of them report is standard representations of the
data, which are run over and over on current datasets.
O Other one is “ad hoc reports”.
5. O ‘Ad hoc’ reports are the format and content,
requested by a user of the data for infrequent
or one-time use.
O Users of standard or ad hoc reports may be
data management staff, clinical research staff
for medical review, management to monitor
progress, auditors, and so on.
6. Methods of Capturing
O 1. Capturing data from source (digital)
documents and forms.
O Where information is available in its
original digital format, tools such as Format
enable organisations to automate the receipt
and interrogation of pdf, Word docs,
electronic forms, instant messaging, etc.,
thus capturing required
7. O data digitally and negating the need to print
and scan these documents prior to using ICR,
OCR, IDR or any of the techniques identified
above. As an example, invoices received via
email in a .pdf format, can potentially have
the required data automatically extracted with
a high level of accuracy and no human input.
O 2. Legacy data import –
O Products such as Alchemy Datagrabber
Module, Format and On base allow
8. organisations with legacy systems (mainframe
systems) to ingest data for improved search and
archival applications.
O 3. Voice Capture :
O The capture of pure voice records and voice
forms is becoming as important for businesses
as other forms of communication (email, web
forms, fax).
9. Data Transfer
O Transfers of data is different from reports in
that the data is copied and sent elsewhere
(either within, or external to, the company)
to be analysed, reviewed, and reported on.
Transfers of data nearly always involve or
include some safety and efficacy data.
Because of this, data transfers should be
guided by “Good Clinical Practice”,
10. and data management must see beyond the
simple creation of an electronic file, which is
just the first step of the transfer process.
O The transfer process involves creation of the
transfer file(s) using a validated program or
application, checking correct and complete
selection of data, moving the file(s) to the
transfer medium, and preparing transfer
documentation.
11. Verification
O ”Verification is a process wherein different
types of data are checked for accuracy and
inconsistencies after data migration is done”.
O How to do ?
O Verification also known as “Cleaning Data”
12. O The biggest job for any data management group
running a paper based trial is not the entry of
the data into a clinical database — it is
checking the data for discrepancies and getting
the data cleaned up.
O Each discrepancy is registered or stored in
some way until it can be resolved.
O There are two ways to do this…
O 1. Manually
O 2. Automatic
13.
14. O 2. Automatic
O Automatic verification is done by software
application. Ex. SAS, SPSS, Excel etc.
O In order to demonstrate data cleaning
techniques, a small raw data file called
PATIENTS,TXT. We will use this data file and,
in later sections, a SAS data set created from
this raw data file, for many of the examples in
this text. The program to create this data set
can be found at the end of this paper.
15.
16. O In SAS the two important term are widely used “PROC FREQ”.
O Proc MEANS requires at least one numeric variable in SAS
verification process.
O FREQ stands for frequency.
O These checks to identify discrepancies are frequently called “edit
checks.”
O PROC FREQ DATA=PATIENTS;
TITLE "FREQUENCY COUNTS";
TABLES GENDER DX AE / NOCUM
NOPERCENT;
RUN;
VERIFY(CHARACTER_VAR,VERIFY_STRING)
17. O Result = Character missing, Gender { invalid
no.}
O Getting signatures :
O “Sign and date” is crucial part of verification,
Some companies require that the principal
investigator (PI) or authorized signatory need sign
for resolving each discrepancy.
Computer capture purpose = To capture some document that can not be downloaded, modified or changed. Ex. In websites, pages can not be downloaded as doc.
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XML = ?
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Alchemy datagrabber = It is a software which used as (Computer Output to Microfilm) replacement applications, or for creating large image archives.
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The biggest job for any data management group running a paper based trial is not the entry of the data into a clinical database — it is checking the data
for discrepancies and getting the data cleaned up.
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Statistical Application System = SAS
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