# Presentation: 216745

## 
EDRN’s Validation Study Information Management System

Developed for EDRN by the DMCC

**EDRN’s ****Validation Study Information Management System**
- Developed for EDRN by the DMCC

- Cancer Biomarkers Group
- Division of Cancer Prevention

- Jet Propulsion Laboratory
- California Institute of Technology

## VSIMS Enter Page

## VSIMS: Users & Permissions

| User Rights | Permission |
| --- | --- |
|    Administrator rights  |       Initiate/update new study. Enter, update, and delete information (excluding participant data) of any study. Read any information from any site in any study. |
|    Key staff rights |       Enter, update, delete information (excluding participant data) for a specific site, specific study. Read any information from any site within the study. |
|    Working rights  |       Enter, update, delete information (excluding participant data) for a specific site within the study. Read any information within the site and study |
|    Master visitor rights |       Read any information from any site within the study. |
|    Visitor rights |       Read any information within the site and study. |

## VSIMS Home Page

## Current Projects using VSIMS

- MSA
- DCP
- Breast Standard Specimen Reference Set
- Prostate Standard Specimen Reference Set

## Submit Data

- This feature captures all the clinical and epidemiologic data required for a study
-  Audit trail
- Built-in edit checks
- Easy access to instructions
- Print copies for site’s records

## Submit Data Forms

## CDE Use

**CDE Repository:**

**Study** **1**

**Consent**
**Form**

**Consent**
**Form**

**Eligibility**
**Form**

**Baseline**
**Form**

**Specimen **
**Collection**
**Form**

**Baseline**
**Form**

**Study 2**

- Date Consent Signed

- Date of Birth

- Have you ever smoked?

- Date of Blood Collection

## Built in Edit Check

## View Instruction of Specific CDE

## Confirmation Page

## Confirm Eligibility

- Confirm eligibility of potential participants and assign them to a study arm
- Ineligible Notes display if participant does not meet the eligibility requirements
- Participant Status: Confirmed, Pending or Ineligible

## Specimen Tracking  System

- Tracks Original Specimen and Associated Children Specimens
- 2-D Barcoding
- Possible Specimen Tracking Data Elements:

- Specimen ID
- Participant ID
- Specimen collection date
- Participant visit code (e.g. baseline, follow-up)
- Specimen source (e.g., blood, urine, bone marrow)
- Specimen stored (e.g., serum, DNA)
- How specimen processed

- Quantity
- Quantity unit ( e.g., ml )
- Lab specimen stored
- Building
- Room
- Refrigerator
- Box
- Column
- Row
- Specimen status (e.g., good, used, defective and reason)

## Specimen Tracking System

- Assay laboratories are blinded to participant information by using a Pair ID number or Specimen ID number that doesn’t link back to Participant ID
- All specimens collected in standardized fashion
- Cases and Controls are paired according to matching criteria defined in protocol
- Pull Lists are created and Algorithm Batch Lists are designed for processing lab

## Enter New Specimen

## Assay Results

## Reports(Real-time Study Specific Reports)

- Participant Reports
- Enrollment
- Adherence
- Completeness
- Audit Trail
- Specimen Reports
- Defective List
- Specimens Collected
- Status of Assay Results
- Pull Lists

## Example of Enrollment Report

## Issue Tracking

- Tracks all correspondence between the study sites and labs and the coordinating center
- Tracks correspondence within the coordinating center (Project Requests linked back to FDA documentation)
- Tracks Data Clarifications

## Inquiry to Coordinating Center

## Other Components (Data Transfer)

## Other Components

- Study Information
- Protocol
- IRB
- Manual of Operations
- Mailing List Subscriptions
- Directory

## Administrative Functions for DMCC

- User Account Manager
- Protocol Manager
- Protocol Registration
- File Manager
- Mailing List Manager
- Login Report
- ID Number Generator

## FDA Compliance

- Category 5 Custom Built Software
- Electronic data stored in 21 CFR Part 11 compliant manner through validation process and SOPs
- Master Plan, Risk Assessment, Installation-Operational-Performance Qualifications, URS, FS, Program Development Standards & Code Review, Test Cases & Matrix
- Currently satisfies FDA requirements:

## Summary

**Flexibility:** Online data entry screens and physical forms are defined by metadata and automatically generated
**Consistency:** Common framework results in efficient re-use of  Common Data Elements (CDEs)
**Ease of Implementation:** Data entry screens and physical forms are created by non-technical staff via a user-friendly interface
**FDA Compliant:** Validation Package and SOPs
**Traceability:** Full audit trail and versioning

## Thank YouJackie DahlgrenDMCC Project Director

- _[jdahlgre@fhcrc.org](mailto:jdahlgre@fhcrc.org)_
- (206) 667-4170