Computer Capture& Verifications

Presented By : Ramkrisna B.

M.Sc. Clinical Research & Experimental Medicine

Chettinad University, India

“Computer Capture”O“Any process for converting &

transferring information into a form that can be handled by a computer”

OEx.- 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.

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.

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”.

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.

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

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

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).

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”,

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.

VerificationO  ”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”

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.

OEach discrepancy is registered or stored in some way until it can be resolved.

O There are two ways to do this…O 1. ManuallyO 2. Automatic

O2. AutomaticO 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.

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)

O Result = Character missing, Gender { invalid no.}

OGetting 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.

OQuestions Are welcome…?