Reports

Purpose

The Integrated Dashboard was designed to serve as a single, authoritative source of truth for operational and performance metrics across clinical research activities. Its primary objective is to consolidate fragmented reporting into one standardized, reliable, and automated environment that supports consistent decision-making, oversight, and enterprise-level reporting.

Background and Problem Statement

Prior to the development of the Integrated Dashboard, multiple challenges existed:

• Numerous stakeholders required slightly different views of similar data.
• Metrics were sourced from multiple, uncoordinated dashboards and datasets, including CTSI and other reporting mechanisms.
• Data inconsistencies and duplication led to confusion and reduced confidence in reported results.

These factors made it difficult to evaluate performance, monitor progress, and communicate results clearly and consistently

Core Design Principles

1. “Single Source of Truth” – All metrics displayed in the Integrated Dashboard originate from unified, standardized data sources. Regardless of who reports or presents the data, all views are derived from the same underlying dataset to eliminate discrepancies and ensure clarity.

2. Full Integration – The dashboard consolidates data that was previously distributed across multiple tools and reports into one integrated environment. This includes accrual, biobank data, industry-sponsored study metrics, and other key performance indicators.

3. Automation – Wherever feasible, data ingestion and visualization are automated to:

• Reduce manual effort and risk of error
• Enable consistent, repeatable reporting
• Support timely availability of information

4. Comprehensive KPI Coverage – Over time, additional fields and metrics were intentionally added to ensure the dashboard captures the full set of required KPIs, including cumulative and enterprise-level measures that were previously unavailable or inconsistently reported.

Visualization and Functionality

The dashboard supports flexible analysis and communication through:

• Filtering and views by Principal Investigator’s name; Principal sponsor; School; Department; Protocol type; Primary Management Group; Status Group; Current OnCore Status; Center Selection.
• Display of cumulative metrics over time
• Display of cumulative metrics over time
  
  

Role in Broader Deployment

This logic framework is intended to:

• Provide historical context and rationale for the Integrated Dashboard
• Support future communications and memos related to enterprise-wide deployment and adoption
• Reinforce shared understanding of why consolidation, automation, and standardization are essential

Enterprise Clinical Research Goal: The percent of IU Health patients seen at an IU Health clinic or facility who have engaged in clinical research. This includes patients who have consented, enrolled, or participated in (by providing a sample or in some other way) clinical research.

Biobank Enrollment Performance: Unique number of IU Health patients who have consented to the Indiana Biobank and the number of patients who have had a blood sample collected for DNA.

Studies Open to Accrual: Studies that are currently in OnCore with a status of “Open to Accrual.” Dashboard filters apply.

Total Subjects Consented: Includes only the number of participants with Consented Dates in OnCore. This number does not include participants who are prescreened and is not available for studies where Summary Accrual is being collected.

Total Subjects Accrued: Number of participants registered individually in OnCore with an On Study date, regardless of current status, or listed as enrolled/accrued under Summary Accrual.

Percent of Accrual Target: Total of Subjects Accrued, as defined above, divided by the number of subjects targeted for enrollment. The number of subjects targeted for enrollment is pulled from the RC Total Accrual Goal (Lower) within OnCore. This is multiplied by 100 to provide a percentage.

Total Accrual Ratio: Percent of Accrual Target, as defined above, divided by the percent of the accrual period to date. The percent of the accrual period to date is defined by the number of days elapsed since the study opened to enrollment, divided by the expected number of days the study will be open to enrollment. The expected number of days a study will enroll is pulled from the Accrual Duration (Months) field within OnCore. The calculated number is multiplied by 100 to provide a percentage.

By looking at Accrual Ratio, we can determine if accruals are ahead of or behind schedule. An Accrual Ratio below 100 would indicate you were behind schedule, while an Accrual Ratio greater than 100 would indicate you were exceeding expectations.

Note that this calculation assumes a linear rate of accrual over the enrollment period. While accruals may not happen in a linear, constant manner, this is viewed as a reasonable way to approximate the current accrual ratio for a study.

Days to Open: The time between the first study submission to an IU office (Office of Clinical Research, Office of Research Administration, Cancer Center SRC, or the IU IRB) and the Open to Accrual date documented in OnCore.

IRB Turnaround Time: The time between submission of a new study to the reviewing IRB and final IRB approval. IU reliance approval times are not included for studies using external IRBs.

Coverage Analysis Turnaround Time: The time between when a study is added to the queue within the OCR and the OCR Signoff/Account Signoff date in OnCore. This does not measure the time between the preliminary review being complete and Final Signoff Readiness, nor does it capture On Hold timeframes. This is currently not available for studies managed by the Cancer Center CTO, and metric calculations will be updated in Q3

Contract Turnaround Time: This does not distinguish between the time the contract was with the Sponsor or the study team.

ORA: The time between the Contract Assigned date and the Contract Fully Executed Received date as documented in KC Grants.

OCR: The time between the Routing Complete date and the Contract Fully Executed Received date as documented in KC Grants.

NOTE: These do not distinguish between the time the contract was with the Sponsor or the study team.

Time to First Subject Enrolled: The time between when a study is Open to Accrual and the first participant enrollment as documented in OnCore.

Dropout Rate: The percentage of enrolled participants who withdraw or are lost to follow-up before study completion as documented in OnCore.

Time to Accrual Close: The time between the first study submission to an IU office (Office of Clinical Research, Office of Research Administration, Cancer Center SRC, or the IU IRB) and the Closed Accrual date documented in OnCore.

Time to IRB Close: The time between the first study submission to an IU office (Office of Clinical Research, Office of Research Administration, Cancer Center SRC, or the IU IRB) and the IRB Closure date documented in OnCore. Studies Terminated in OnCore without IRB Closure dates will not be included.

Submission to OCR/CTO Signoff: The time between the first study submission to an IU office (Office of Clinical Research, Office of Research Administration, Cancer Center SRC, or the IU IRB) and the OCR Signoff/Account Signoff date in OnCore.

OCR/CTO Signoff to Open to Accrual: The time between the OCR Signoff/Account Signoff and the Open to Accrual date as documented

A workgroup was formed to align on reporting clinical study portfolio metrics and clinical study performance indicators, including how to display portfolio performance and study progress visually. We aimed to determine the single data source, who is responsible for reporting the data, and how metrics can effectively be communicated to key stakeholders. The process has helped identify opportunities for streamlining, elimination of duplicated efforts, and will result in more efficient processes. We also plan to look at ways to automate the dashboard and associated mechanisms to retrieve the data.

Learn more about the Key Performance Indicators (KPIs)

We are collecting accrual data to enhance our ability to develop performance improvements that increase planned subject accrual into clinical studies.

Reports will be sent to IU and IU Health senior leadership as well as NIH.

Data will be collected from OnCore for all studies open to accrual during a specified timeframe, typically quarterly or annually. Data will be reported at the individual study level, in aggregate at a departmental/division level, and at the enterprise level.

The following data will be reported from OnCore for each study:

• Number of subjects accrued
• Number of subjects targeted for accrual
• Number of days elapsed since the study was opened to enrollment or number of days the study was actually open.
• Number of days the study is estimated to enroll subjects

• Check the protocol for enrollment timeline
• Determine if enrollment for the protocol has just begun or will IU/IUH begin enrolling midway through the enrollment timeline
• Take into consideration where enrollment is at in real time
• Consider the time it will take to reach the RC Total Accrual Goal (Lower) field in OnCore

• Along with Affiliate Accrual Goal, the RC Total Accrual Goal (Lower) should be entered. The RC Total Accrual (Lower) goal may be duplicated from the Affiliate Accrual Goal.
• See Question below: What standard fields are required to be completed in OnCore?

Protocol No.

The unique identifier for the protocol. It should be formatted as follows: Acronym for Primary Management Group-Sponsor-PI-Short Title for study (i.e. GI-ROCHE-EINHORN-BETA)

Title

The full-length Title as listed on the protocol document.

Principal Investigator

The Principal Investigator is the PI of record at the IRB.

Department

Department identifies the department or division associated with the principal investigator of record at the IRB.

DT4 Report Type (Cancer Center Only)

DT4 Report Type may be Ancillary or Correlative, Interventional, Observational or Not Applicable. Refer to definitions on the IUSCC intranet site for more details.

Protocol Type (Cancer Center Only)

For Cancer Center studies Protocol Type may vary based on Interventional or non-Interventional protocols. Refer to definitions on the IUSCC intranet site for more details.

Protocol Type (non- Cancer Center)

Protocol Type may be Interventional, Observational or Expanded Access. Refer to definitions for the Minimum Standardized Requirements for Protocol Entry found on the OnCore Training & Support page. Protocol Type should match the Study Type listed in ClinicalTrials.gov.

Open to Accrual Date

Open to Accrual Date is the date on which the institution is open to accrual/enrollment. This means all required reviews are complete, sponsor authorization obtained, and the research group is fully prepared to begin seeing patients. This date may be on or after the IRB Initial Approval Date.

Accrual Duration (Months)*

Accrual Duration (Months) estimates the number of months you plan to locally enroll patients or participants on the study. This may not be the accrual duration listed within the protocol document.

RC Total Accrual (Lower)*

RC Total Accrual Goal (Lower) estimates the minimum number of subjects you plan to enroll locally. The RC Total Accrual Goal (Upper) data can be duplicated in this field. NOTE: Studies that have “open enrollment” where there is no set accrual goal, the RC Total Accrual Goal (Lower) field must be updated quarterly.

*Can be updated as needed to match the current status of the study.

The number of subjects accrued can be based on either individual subject registrations or summary accruals.

• Summary Accrual Info Only? Protocols must have accrual numbers entered quarterly (i.e. January 1-March 31, April 1-June 30, July 1-September 30, October 1-December 31)
• Studies with individual patient registration must ensure all enrolled subjects have an On Study Date in order for the numbers to count.

Summary Accrual data may not be on the report based on the time the report is generated (i.e. reports run on May 31st will not include 2nd quarter accruals).

This metric is the ratio of the following 2 percentages:

• Accrual Percentage (the actual number of subjects enrolled divided by the number of subjects targeted by the completion of the trial, multiplied by 100 to get a percentage)
• Percent of Accrual Period to Date (the actual number of days elapsed since the study opened to enrollment divided by the expected number of days the study will be open to enrollment, multiplied by 100 to get a percentage).

**Accrual Ratio = Accrual Percentage/Percent of Accrual Period to Date x 100

By looking at Accrual Ratio, we can determined if accrual is ahead of or behind schedule. An Accrual Ratio below 100 would infer you were behind schedule, while an Accrual Ratio greater than 100 would infer you were exceeding expectations.

Note that this calculation assumes a linear rate of accrual over the enrollment period. While accrual may not happen in a linear constant manner, this is viewed as a reasonable way to approximate the current accrual ratio for a study. An example of non- linear accrual may include trials with intermediate, planned holds on accrual for interim evaluation.

Data will be collected quarterly, typically the first of each month following a quarter.

If IU is leading the multi-site study, accrual from all sites should be included. Accrual numbers should be listed under the appropriate enrollment sites within OnCore.

If IU is only participating in the multi-site study, only accrual from IU and its local affiliates should be included.

All accrual should be entered and assigned to the appropriate enrollment sites within OnCore.

If your research team requires additional training on the entry of accrual data into OnCore, please contact us at oncore@iu.edu to attend an upcoming training session. If you have questions regarding the accrual metric, please contact the Office of Clinical Research at ocr@iu.edu.