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Data Validation OPEN Development Conference September 19, 2008 Sushmita De Systems Analyst

Data Validation OPEN Development Conference September 19, 2008 Sushmita De Systems Analyst

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Data Validation

OPEN Development ConferenceSeptember 19, 2008

Sushmita De

Systems Analyst

09/19/08 Data Validation 2

Data Validation Overview….

OPEN application accepts registration data from the user, and transfers the registration data to the lead group’s RandoNode for processing. This document

describes the process to verify the data transfer integrity between OPEN and RandoNode.

09/19/08 Data Validation 3

Purpose of Data Validation….

These validation processes do not handle any physical transmission error. The primary purpose of these tests is to uncover any system defects and to

prove system functionality.

09/19/08 Data Validation 4

Scope of Data Validation…

• Validate the persistence of data from OPEN screen into OPEN Randohub database.

• Validates the integrity of the data sent from OPEN to RandoNode.

Scope: OpenRequest , OpenRegistration and ODM (metadata and clinical data).

• Validates the integrity of the data sent from RandoNode to OPEN.

Scope: OpenResponse

• CTSU’s local RandoNode was used for persisting the data to the database.

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Steps for Data Validation from OPEN screen to OPEN database…

• Enroll a patient using OPEN portal

Enter group information, protocol information, Credit information

and all associated administrators information and check list data.

• There are two ways to verify Screen data persistence :

1. Compare hard copy data to OPEN screen.

2. Compare hard copy data to Randohub database.

09/19/08 Data Validation 6

Steps for Data Validation from OPEN screen to OPEN database…(continued)

1. Compare hard copy data to OPEN screen.

Query for the selected registration data in OPEN Manually verify the summary page & eligibility checklist with

hard copy.

2. Compare hard copy data to Randohub database.

In Randohub database, MYRESP view contains the registration data

Query MYRESP view with the registration id (Tracking #) Manually compare the query result with hard copy.

09/19/08 Data Validation 7

Steps for Data Validation from OPEN to Randonode & Vice Versa

• Open Portal saves the data in Randohub schema for both request sent and response received.

• Randonode saves the data in Randonode schema

• Sql validation scripts compare data between Randohub (OPEN database) and Randonode.

• Validation scripts create and store data in temporary tables in Randonode to compare the data.

• In all cases if test is passed, resultant temporary table will not contain any data, otherwise it will contain the records which are not matching in either schema.

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Randonode Data Model…

Adobe Acrobat Document

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Validation Observations

• Identified few data discrepancy which were difficult to identify through system integration testing, since in most of the cases generated final output was correct.

• Few of these observations are related to persisting data in Randonode, not affecting group transaction.

• All of the observations have already been fixed except two for which the work is under progress.

09/19/08 Data Validation 10

Observations corrected……

• LF(Line Feed) was getting appended to few of the text fields during data transmission to RandoNode.

• CreationDateTime of ODM node in metadata was not getting saved in database.

• ODM.Creation_Date_Time, Open_registration. Randomized_Date was saving only the date part.

• For all kind of investigators (treating investigator, drug shipment investigator etc.), “IVR” was sent as OPENUserType in clinical data. This was creating confusion for same person playing multiple roles.

09/19/08 Data Validation 11

Observations corrected……(Continued)

• For Treating & Drug shipment investigators, user type sent in clinical data supposed to be “Investigator” instead of “other”.

• For multiple items having same codeList values, codeLists were not getting saved properly in database.

• Randohub.open_responses(in OPEN database) table was not getting populated with the response detail received from groups.

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Observations…Work in progress…..

• Override requests are associated with only override codes, not with edit checks.

• Override requester and reviewer detail are not present in admin section of clinical data.

• Both of these depend on procedures that are being developed.

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Future Plans for Validation…

• Validate the integrity of the data sent from OPEN to .Net RandoNodes.

• Validate groups’ RandoNode response time during load testing.

• Validate meta data files content in the RandoNode repository against the CaDSR repository based on the form’s public id.