Monitoring Reports that Assist with Remote Monitoring Kayla Daniels, MS

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

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)

Protocol Reports Subject Status: Where subjects are in the trial (screening, randomized, withdrawn, etc.)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

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

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

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?

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?

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

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

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

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

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

Questions?