# Presentation: 276698

## Population Tracking System

- Version 1.0 Walk-Through

- Presented by:
- Office of Extramural Research
- Dr. Della Hann
- Mr. Dan Hall

- May 2002

**Notes:**
Thank you for having us here today.  We would like to provide you with an overview of the new Population Tracking System that will be deployed as an IMPAC II module on May 17th and available for use on May 20th.

I am Dr. Della Hann, Office of the Director, Office of Extramural Research (OER) and I am joined by Mr. Dan Hall, Systems Analyst for the eRA project

## Project Background

- In FY 2000, ORWH requested a full business re-engineering of the Population Tracking System:
- Result of 2000 GAO recommendation to improve the accuracy of the population tracking system
- Redesign based upon the following Goals:
- Central Repository of Population Data
- Integrated with IMPAC II Transaction Data
- External API to Interface with Existing IC Systems
- Consistent Workflow and Reporting of Protocols across ICs

**Notes:**
In FY 2000, the GAO conducted a study of the NIH’s compliance with the Inclusion of Women and Minorities in clinical research. Although the report was favorable, it  concluded that NIH’s the existing system for tracking study populations was deficient and steps should be taken toward improving the system.  With that finding, ORWH requested assistance in re-engineering the population tracking system.

Major goals for the new system were:

There be a central system that all IC’s could use to record and store the population data
This new system should be integrated with the IMPAC II system & be part of the overall eRA enterprise system.
The new system would be capable of interfacing with existing IC systems that record & store pop data...so that IC’s could continue to use their systems AND the data would also be stored in the central repository.
New system would be user friendly and support consistent workflow for data entry & reporting of protocols within an IC and across IC’s.

## Population Tracking Focus Group

**Karen Bashir (NIA)**
**Angela Bates (ORWH)**
**Lisa Begg (ORWH)**
**Ann Carpenter (NCI)**
**Renee Edwards (CIT)**
**Vickie Fadeley (OER)**
**Larry Fanning (OER)**
**Carla Flora (OER)**
**Donna Frahm (OER)**
**Michael Goodman (Logicon/ROW)**
**Virginia Hartmuller (ORWH)**
**Kim Jarema (CC)**

**Aileen Kelly (CIT)**
**Darlene Levenson (NICHD)**
**Jack Manischewitz (NIDA)**
**Michael Martin(Logicon/ROW)**
**Sharry Palagi (NHLBI)**
**Mary Lou Prince (NIMH)**
**William Radcliffe (NIMH)**
**Lai Tan (NIAID)**
**Kim Witherspoon (NCI)**
**Sherry Zucker (OER)**
**Beth Patterson (NIDDK)**

**Notes:**
To develop the new system, a Population Tracking Focus Group was formed comprised of members very familiar with the business process of population tracking.  We owe a great deal of gratitude to this Focus group for the commitment and active participation which resulted in the design specifications for the new system.

## Fundamental Features

- Store enrollment data with FY of Progress Submission
- Access Grants and Grant/Protocols that Require Tracking
- Activity Codes
- Clinical Trial Code & Human Subjects Code
- Exception Codes
- Store Both New Form and Old Form Submitted Data
- Access Subprojects
- Support Domestic and Foreign Populations
- Associate Multiple Protocols within a Single Grant
- Associate Single Protocol with More than One Grant
- Allow User to View and Retrieve Subject Counts

**Notes:**
Through the efforts of the Focus Group, additional requirements for the new system were developed.  In particular, requirements were developed to help improve consistency in the way data were entered and yet allow for some flexibility across the Ics.

These discussions resulted in some fundamental features of the new system:

First, to improve consistency across the IC’s, the new system will store enrollment data in the FY that the data are submitted.
Second, Grants & Protocols within the grants that require tracking will be more consistent across the Ics
Tracking & Inclusion Committee developed a list of Activity Codes that require tracking (available in the Jan 2002 training materials on the web)
Grants being considered for tracking must involve NIH-defined Clinical Research. Currently, the designation of clinical research is done by Review and is stored in the NIH Clinical Trail Code field which is linked to the Humans Subjects Code
Tracking and Inclusion Committee developed a revised list of Exception Codes (available in the Jan 2002 training materials on the web).
Conducting staff training on the policy & implementation of tracking in Jan 2002 – to improve consistency

New system must be capable of allowing folks to enter & store data in the new format and the old format
New system must allow access to subprojects
New system must provide a way of sorting protocols that involve Domestic Populations from those involving Foreign populations because of the need of separating these populations when running reports
New system must provide a means of associating multiple protocols with a single grant.
New system must provide a means of associating 1 protocol with more than one grant.
New system must allow the user to view subjects counts & retrieve this information within the IC

## Population Tracking Process Flow

- Enter Population
- Target Data

- Verify Target Data (if avail)

- Receive Progress Report/Type 5

- Enter Enrollment Data

- Verify/Monitor /Approve Enrollment Data

- Code for Human Subj & Clinical Trial

- Award Grant

- Crisp Indexing of Subprojects

- Identify Trackable
- Applications

- IC Receives Grant

- IC Grants
- Operations

- IC Grants Ops/ Pgm
- Supt./Grants Mgmt.

- IC Grants Ops/ Pgm
- Supt./Grants Mgmt.

- Award Grant

- Grants Mgmt.

- Peer Review

- Track Avail./Missing
- Required Pop. Data

- PO/Pgm Area Dir./IC Focal Point for Pop. Track/ORWH

- Issue Offical Pop. Tracking Repots; Perform Analyses

- IC Focal Point for Pop. Tracking/ ORWH

- OD/Div.of
- Research Doc.

- IC Grants Ops/ Pgm
- Supt./Grants Mgmt.

- IC Grants Ops/ Pgm
- Supt./Grants Mgmt.

- Program Official

- Program Official

**Notes:**
The following chart is a representation of the process flow for population tracking.  It depicts the function and the responsible user for that function.  Instantly it becomes apparent that the Ics do not do things the same way.  Although the process is the same the responsibility varies from IC to IC.

This is the reason why the system needed to be developed with some fundamental features AS WELL as some flexible features. 

## Population TrackingDesign Considerations

- Consistent “Look and Feel” of IMPAC II
- 640 by 480 Screen Size
- Workflow (i.e. Search, Hitlist, Selection)
- Multiple Protocol Studies per Grant
- A Protocol Assigned to More than 1 Grant
- Data Capture Emphasis for 5/2002 Release

## System Walk Though

## Screens

- Population Tracking consists of seven (7) primary screens:

- POP0000     Banner
- POP1000     Grant Search
- POP1020     Assign Protocol
- POP1300     Old Form Subject Counts
- POP1400     New Form Subject Counts
- POP6010     Pop Snapshot Report
- POP6020     Discrepancy Report

**Notes:**
Our proposed system consists of six (6) screens.  I’ll now turn the presentation over to my colleague Dan Hall.

touch briefly on the purpose and functions each provides.  Please keep in mind as we go through these screens that they are preliminary and may change during development.

## Banner Screen (POP0000)

## Grant Search (POP1000)

## Grant Search Results (POP1000)

## Assign Protocol (POP1010)

## Edit Protocol (POP1020)

## Search Protocol (POP1000)

## Slide 15

## New Form Target Data (POP1400)

## Slide 17

**Notes:**
New Enrollment Table from the 398

## New Form Enrollment (POP1400)

## Enrollment Totals (POP1400)

## Old Form (POP1300)

## SNAP Report (POP1500)

## Discrepancy Report (POP1600)

## July/October Initiatives

- Aggregate Reporting
- Quality Control Reporting (In addition to Discrepancy Report)
- Workflow (e.g. Automated Assignment of Protocols)
- Query Reporting (IRDB)
- Attributes Defined by Users (e.g. Enrollment Status)
- Administration Interfaces (e.g. Activity Code Maintenance)

**Notes:**
Reports and Output Products are requirements we’ve just skimmed the surface on.  After the project moves into production, we’ll be meeting once again with our focus group to discuss the how, what and when of population reporting.  We have, however, identified several types of reports that will be needed although the specifics are still unknown, they are:
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Official NIH Reports – these are reports generated from the Office of Research on Women’s Health
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IC Reports
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Missing Data Reports
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Population Snapshot Report
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Population Workload Report
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IC Council Report
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Download Extract
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Updates Made after Official Report Date Report

## Deployment Milestones

- May 6th – NIH Tracking & Inclusion Committee
- May 10th – eRA Symposium
- May 20th – Production Release
- Week of May 27th (tentative) – Road Show1
- Week of June 3rd (tentative) – Road Show 2
- Week of June 10th (tentative) – Road Show 3
- June 17th Training Sessions Begin

## Deployment Tasks

-  IC User Admins Grant Roles
-  POP_TRACKING_UPDATE_ROLE
-  POP_TRACKING_APPROVAL_ROLE
-  Application Setup
-  Deploy to Desktop
-  IC Conversion
-  5/20 for ICs Currently Holding Data Forms
-  5/20 External API available for Existing Systems
-  June for ICs Using Spreadsheets

**Notes:**
Privacy and Security
Initially, there will be five(5) user roles associated with the Population Tracking system.  As you can see from the chart three(3) of them, the POP_TRACKING_UPDATE_ROLE, POP_TRACKING_APPROVAL_ROLE, POP_TRACKING_DATA_ADMIN_ROLE will be specifically created for the purposes of population tracking.  The ICO_PROGRAM_OFFICIAL_ROLE and the ICO_GRANT_UPDATE_ROLE are existing user roles that will provide additional authority to the user in setting the approval flags and updating grant information, respectively.

## Thank Youfor Attending