14 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.

14.1 Monitoring Methods

The Monitoring Tab allows you to indicate the monitoring methods with the “Monitoring will be performed” field and the “Monitoring Travel Strategy” field.

• 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.

• Monitoring Travel Strategy: This field allows you to specify the travel strategy to be used for most of the monitoring trips. Spoke monitoring is when the monitors will return to their home/office between each site visit. Loop monitoring is when monitors will travel to site 1, then to site 2, then to site 3, etc. before returning to their home/office.

14.2 On-Site Monitoring Schedule

The Monitoring Tab allows you to indicate the schedule for on-site monitoring.

• Monitor Every: This value indicates how frequently a monitor will visit the sites in the study during each period of the monitoring schedule.

• until LSO/LPO: Selecting this radio button indicates that site monitoring will continue at the specified frequency throughout the end of the treatment period. If the monitoring frequency will change during the treatment period, the “until week” radio button should be selected and a new frequency defined for the next (or remaining) period.

• Until week: This value specifies the week at which the specified frequency for monitoring will change. This is 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.

14.3 Monitoring Approach

The Monitoring Tab allows you to indicate the amount of time monitors will 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 will be done by normal 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 will be done by Regional Monitors. The remaining monitoring and site management activities will be 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 will still be performed by CRAs or SCRAs.

  
  

• 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.

14.4 Monitored Data

The Monitoring Tab displays the total number of CRF pages that will be 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 will be 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.

14.5 Medical Monitoring

The Monitoring Tab allows you to estimate the number of full-time medical monitors that will be 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.

14.6 Separate Drug Accountability

The Monitoring Tab allows you to account for separate drug accountability visits.

• Will there be additional drug accountability visits? Please indicate whether additional drug accountability visits are required.

• Additional Drug Accountability visits performed by: This field allows you to indicate who will perform 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 will be 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.