13 Monitoring Tab

The Monitoring Tab is used to enter information about the expected monitoring frequency, approach, and to specify which responsibilities will be outsourced or conducted internally.

Monitoring Methods

The Monitoring Methods section allows you to indicate whether monitoring is done in-person and/or by phone, as well as how you want to manage the monitoring schedule values.

Monitoring will be performed: This field allows you to specify whether monitoring will be done in-person or by phone or by a combination of these methods. Typically phone-based monitoring is done only for Phase IV studies or during long follow-up periods.
Manage monitoring schedule values: This field allows you to specify whether monitoring schedule values are managed globally or per location. If monitoring schedules are managed globally, all of the assumptions entered on the Monitoring Tab are applied to all the plan locations in the study.

If monitoring schedules are managed per location, schedules can be modified for each location within the study. The Edit Per Location Monitoring Schedule dialog box allows you to select each location and edit their monitoring schedule.

On-Site Monitoring Schedule

The On-site Monitoring Schedule section allows you to configure the schedule for on-site monitoring.

Monitor Every: This value indicates how frequently a monitor visits the sites in the study during each period of the monitoring schedule.
Until LSO/LPO: Selecting this radio button indicates that site monitoring continues at the specified frequency to the end of the treatment period.
Until week: Selecting this radio button indicates that the monitoring frequency changes during the treatment period and a new frequency will be defined for the next or remaining period. This value represents the week number of the start of the next monitoring period and must be greater than or equal to the value for the monitoring frequency for the prior period.
Total number of on-site monitoring visits: This value is derived from the total number of sites, monitoring frequency, and subject enrollment rate. You may increase this number if you would like to add more monitoring visits. You may also wish to lower the total number of monitoring visits.
Monitoring Travel Strategy: This field allows you to specify the travel strategy to be used for the majority of the monitoring trips. Spoke monitoring is when the monitors return to their home/office between each site visit. Loop monitoring is when monitors travel to site 1, then to site 2, then to site 3, etc. before returning to their home/office.

Monitoring Approach

The Monitoring Approach section allows you to indicate the amount of time monitors spend in the field, as well as which resources are responsible for monitoring.

Percentage of time Monitors spend in the field: This field allows you to indicate the percentage of time monitors spend in the field. It is assumed that the remainder of their time is then spent on site management activities.
Percentage of monitoring done by CRAs (vs. Senior CRAs): This field allows you to indicate the percentage of monitoring and site management that is done by Clinical Research Assistants (CRAs) versus Senior Clinical Research Assistants (SCRAs).
Percentage of monitoring done by Regional Monitors: This field allows you to indicate the percentage of monitoring that is done by Regional Monitors. The remaining monitoring and site management activities is split between CRAs and Senior CRAs according to the value indicated in the field, “Percentage of monitoring done by CRAs (vs. Senior CRAs).”

Note:
The value in this field is not related to travel time or distance. This value is used to split the effort of monitoring and site management tasks across various resources who have different billing rates. Even when 100% of monitoring is done by RMs, some site management activities is still performed by CRAs or SCRAs.
Avg travel time (in hours) for site monitors: This field allows you to enter the average number of hours a monitor needs to travel to sites.
Percent of source document verification: This field allows you to specify the percent of key safety and efficacy data to be source verified while monitoring the data. Most studies require all of the key safety and efficacy data to be verified against the source. Some Phase III and Phase IV studies may not require this level of monitoring for study data.
Time to review queries from previous visit (minutes): This is a calculated value representing the number of minutes required to review queries/CRF data from a previous monitoring visit based on the therapeutic area and indication selected for the study.
Manage location-specific values: Upon clicking Edit Location specific overrides, you can enter monitoring approach assumptions per location. All location-specific values can be overridden from their global default value.

Monitored Data

The Monitoring Data section displays the total number of CRF pages that are generated, with and without subject drops.

Total CRF pages generated (without subject drops): This value is the total number of predicted CRF pages generated, assuming that no subjects drop. It is a summation of all CRF pages entered for each subject visit across all subjects and sites, as defined on the subject treatment schedule.
Total CRF pages monitored (accounting for subject drops): This value represents the predicted CRF pages that are monitored, accounting for any subjects that drop out of the study. This value is derived from the subject drop rate, which is applied to each week of the study in order to calculate the subject retention rate.

Medical Monitoring

The Medical Monitoring section allows you to estimate the number of full-time medical monitors that are needed.

Estimated number of FTE (full-time equivalent) Medical Monitors: This field includes time for a Medical Monitor (MD) to serve as the team medical lead and provide support to the CRA monitoring staff as well as to the Investigators for issues beyond safety reporting.

Separate Drug Accountability

The Separate Drug Accountability section allows you to account for separate drug accountability visits.

Will there be additional drug accountability visits? Allows you to indicate whether additional drug accountability visits are required.
Additional Drug Accountability visits performed by: This field allows you to indicate who performs additional drug accountability visits (if applicable). Separate drug accountability generally applies to oncology and some vaccine studies and is done by someone other than the CRA that monitors the site to assure that all involved in the study are completely blinded to the study drug/test article.
Additional Drug Accountability Visits Per Site: This field allows you to indicate the number of additional drug accountability visits that are made per site. Separate drug accountability generally applies to oncology and some vaccine studies and is done by someone other than the CRA that monitors the site.