1. Monitoring Reports that Assist with Remote Monitoring
Kayla Daniels, MS

2. Preparation is Key
Knowing what you are reviewing before you start the visit is helpful
Review the report from the previous visit
List of outstanding Action Items
Data currency/status reports
During a visit you should resolve outstanding data
Process saves time

3. Data Reports How does Emmes use these reports?
Assessment of site quality
Opportunities for retraining
Identify possible missing data (missed visits/PDs)
Identify regulatory deficiencies (RTS Reports)

4. Protocol Reports
Subject Status: Where subjects are in the trial (screening, randomized, withdrawn, etc.)
Visit Status: Dates of visits that have occurred
Consent since last visit: Date subjects came in since the consent was IRB approved – monitor knows to check reconsent
GlobalTrace reports: Status of specimens at the site laboratory
RTS reports: Status of regulatory documents

5. What other reports do you think may be helpful in preparing for and conducting a remote visit?

6. Data Reports Missing Values Report Missing Forms Report
Integrity/anomaly Report
PM Field Discrepancy Report
PM Query Report
Monitoring Status Report
Site Departure Report

7. Missing Value Report
Missing values show in the report when a form has been entered but some required data points are missing
Some considerations:
Has the data just not been entered?
Is the data point out of range and the system won’t accept it?
Were the data really not collected?
How to resolve?
Request a missing value exception, data manager grants
Initiate an out of range request, data manager expands range
Is this a protocol deviation?

9. Missing Forms Report
Missing forms occur when the system “triggers” a form to be entered, but it has not occurred within the expected window
Some considerations:
Have the data not been entered?
Was the visit or assessment missed?
How to resolve:
Request missing form exception, data manager grants
Is this a protocol deviation if the visit was missed or out of window?

11. Integrity Reports Automatic data queries
Searches for inconsistencies between forms/fields
How to resolve:
Data are fixed, and query automatically goes away
The anomaly is “granted” because the data entered was correct

12. PM Field Discrepancy Report
A list of outstanding and resolved monitoring discrepancies
Outstanding discrepancies can be resolved or verified during the remote visit
Also shows site what is created during visit so they can resolve in real time
Can be used to determine data error percentage
Can help identify trends

14. PM Query Report Not the same thing as a discrepancy!
PM queries allow the monitor to type a “query” that does not create a discrepancy
The site is able to respond to the query in the system
Monitor can clear out the query or respond if further clarification is needed
These do not usually count in performance metrics

16. Monitoring Status Report
Used usually for risk-based monitoring
Is programmed in accordance with the clinical monitoring plan
The site cannot see the MSR
For remote visits, can be used to determine which patient charts the site needs to scan in prior to the start of the “visit”
Randomly selects forms to monitor based on required parameters
For example, 100% eligibility, 25% AEs, 10% PDs

18. Site Departure Report
At the end of the visit, this report summarizes the data review statistics
Number of fields monitored
Number of forms monitored
Number of discrepancies created
Data error rate
Again, can be used as a site metric
Acceptable data error rate is determined in the CMP
High error rates may constitute 100% SDV or an on site visit

20. Questions?