clinportal a clinical data management solution. what is clinportal? web-based, data collection tool...

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ClinPortal A Clinical Data Management Solution

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ClinPortal A Clinical Data Management Solution

What is ClinPortal?

Web-based, data collection tool

Developed at Washington University School of Medicine

Designed for the following types of studies• PI Initiated Studies• Disease-oriented groups (Patient ‘databases’)• Multi-institutional studies/trials

Application integration• Tissue Suite• CIDER

Grant Supported• Standardized vocabulary• Reuses clinical variables• Data sharing• Identified, De-Identified (HIPAA compliant)

What is a ClinPortal Study?

ClinPortal has 2 roles: PI and Coordinator

Both roles have the same privileges: full identified PHI for all participants on all forms, unless otherwise specified by PI

Complete Protocol Title per IRB approval

Familiar, shortened titleIRB #IRB documented start date for protocol

Consent

Tiered Consent Updated Queryable Upload signed copy

Participant

Overview

IRB approved Consent

& Protocol

Study Calendar

ClinPortal

Visit Details

Event

Visit

Form

Form Elements

Text Box- integer

Drop down list- PVlist

Text-decimal (x.xx)

Boolean-check box

Radio Button-PV list

Add More function

Form Elements

Multi-select list- PV list

Date Picker

Unified Model& Standardization

General Study: Family History

Fetal Study: Maternal Medical History

2 different studies: General Study and Fetal Study2 different forms: General Family History and Maternal Medical History

Shared attributes: Relationship and Diagnosis

Data Dictionary

Model

Forms developme

ntLoad

User Mtg

Reuse

Standardization

Study Development Cycle

CSMSAdministrative, Billing, Regulatory

ClinPortalData management

System Integration

caTissue

CIDER

*Lab resultsDemographicsMedicationsDiagnosis ProceduresAdmit/DC

Participant RegistrationStudy ProtocolIRB approval

Encounter datesVisit information

Clinical Research at WUSM

ClinPortal & Tissue Suite

Participant

Clinical StudyRegistration

Collection ProtocolRegistration

Clinical Study Collection Protocol

CS Event CP Event

Visit SCG

Form 1Form 2

Specimen 1Specimen 2

ClinPortal Tissue Suite

How do I access ClinPortal?

User Responsibilities

Follow established rules and procedures Obtain HIPAA/IRB approval if necessary Do NOT share user IDs and passwords Safeguard patient privacy and protect

clinical data sets. Escalate issues/questions to application

Administrator or application Helpdesk Do NOT download, move, or copy

identified/limited data sets to USB drives, CDs, DVDs, other removable devices, or servers/workstations/desktops/laptops on unsecure networks

User access will be revoked in any case of failure to follow the rules.

Access

On campus: accessed from any WUCON connection

Off-campus : accessed with a VPN client

ClinPortal Administrator approved user

Users must have an approved study

Request access on homepage or by contacting our helpdesk at [email protected]

Demonstration

https://clinpd6.cbmi.wucon.wustl.edu:8443/clinportal