All regulatory bodies require 100% SDV, don’t they?
No, regulatory bodies do not stipulate 100% SDV. The FDA released a Guidance document back in 2013, stating its position that 100% SDV and regular site visits do not necessarily ensure data quality or patient safety.
The EMA’s reflection paper released that same year also discusses approaches for centralized and targeted monitoring plans.
How much is data improved as a result of traditional 100% SDV?
As per a study by Transcelerate:
Traditional SDV accounted for only 2.4% of queries in critical data
Traditional SDV accounted for only 1.1% of corrections to the entire data
Results showed 95% of onsite monitoring findings could have been found through central monitoring
What are alternatives to 100% SDV?
The EMA recommends that site monitoring plans deploy a combination of on site and offsite review of source data, the mix of which is to be decided by analysis of risks to patient safety and data quality.
Monitoring plans may include elements of :
CRAs visit the sites for verification of source notes against CRF data at defined intervals
Source data is reviewed from a central offsite facility at planned intervals
Specific datapoints requiring SDV are clearly identified based on risk factors for the subject or site. These may vary between subjects and sites and will be amended as risk factors change.Targeted monitoring (tSDV ) may be done onsite or offsite.
What are the risks of tSDV against traditional 100% SDV?
Is it easy to switch from 100% to Targeted SDV?
Yes. It is predominantly a cultural change. The technology does not affect the monitors or sites in any way except by perhaps making entry screens cleaner and easier.
Are there any additional skills or training required for study monitors or sites to perform tSDV?
Minimal. The study monitor will simply be shown how to interpret signals or trends from lists/graphs that may indicate risks, for example suspicious data or a potential safety issue.
How hard is it to switch back to 100% SDV? How long does it take?
Switching back is a matter of removing the site monitoring configuration for tSDV , so no longer than the click of a few buttons. Study Monitors can go back to 100% SDV the next day. The CRO may continue highlighting risks to point study monitors in the right direction if the sponsor agrees.
Is Targeted SDV the same as Centralized Monitoring?
• Refers to SDV of targeted datapoints, subjects and sites • Can be done Onsite or from a Central Facility
• Allows monitors to access site records from a central facility at least for some visits • Reduces logistics, expenses and associated inefficiencies
Both these elements of verification are complementary in redesigning an increasingly obsolete and inefficient method of Source Data Review It is recommended for effective Change Management to start with a mix of onsite and offsite verification leaning towards more onsite than off This allows a smooth transition for sites and monitors while still improving cost efficiency of the SDV process
What is USFDA’s position on reducing 100% SDV?
"There is a growing consensus that risk based approaches to monitoring are more likely than routine visits to all clinical sites and 100 data verification to ensure subject protection and overall study quality" ~FDA’s Guidance for Industry
“FDA encourages sponsors to develop monitoring plans that manage important risks to human subjects and data quality and address the challenges of oversight in part by taking advantage of the innovations in modern clinical trials" ~FDA’s Guidance for Industry
"A risk based approach to monitoring does not suggest any less vigilance in oversight of clinical investigations Rather, it focuses sponsor oversight activities on risks to data quality and to processes critical to human subject protection and trial integrity" ~FDA’s Guidance for Industry
Why do people refer to Centralized Monitoring as Risk Based Monitoring? Are they the same?
Risk Based Monitoring is an element of a Quality Management System, within which studies are conducted, that allows errors impacting data quality and patient safety to be identified and actioned before they affect the outcome of a study It SUPPORTS Centralized Monitoring and tSDV by identifying areas where monitors should increase their focus to prevent potential risks from jeopardizing patient safety or study data quality
What kind of information might an RBM system highlight?
Just a few examples:
Site Performance Grades and Progress Reports to indicate and manage site performance Enrolment information regarding numbers enrolled versus target
enrolments and accuracy of subjects as per eligibility criteria
Regular updates for Medical Monitors to ensure patient safety criteria are not violated
Reports regarding suspicious or inauthentic data for appropriate, on time action
Lab value outliers for individual subjects compared with trends for the whole dataset Just a few examples:
Are we ready for an RBM based tSDV system?
Do you have a DM Department or Provider who can take care of RBM and tSDV aspects for you from start to finish?
Do RBM and tSDV modules blend seamlessly into the EDC/eSource solution used by your sites?
Are your Study Monitors diligent and eager for technological support to increase their productivity?
Do your Study Monitors wish for better communication with and more feedback from the Data Management team?
Will your sites welcome the reduction in meaningless hours of 100 SDV?
And lastly, will you welcome the saved expenses from reduced travel, lodging and boarding costs for largely unproductive activities?
Congratulations. If you answered ‘Yes’ to all the questions above, you are ready to move into the future of Clinical Trials.