In this webinar, you will learn how implementation, evolution and change management are critical for a successful remote monitoring program. But how does a remote monitoring program harmonize with current SDV practices?
Source Data Verification (SDV) is, however, a fundamentally non-value added activity. It is a quality control step that fails to produce quality but seeks to test the quality of the data, an approach widely recognized as being inefficient and ineffective. As a non-value added activity, it should be a prime target for cost reduction while at the same time sustaining and increasing the integrity of clinical data with the source records on site. Recently, the pendulum has swung from 100% non-discriminating SDV to extremely low levels. An example of a Sponsor’s reduced algorithm for a post marketing study significantly reduced the amount of data items under review and focused primarily on data.
Items considered critical to the submission: The Sponsor set monitoring guidelines at 10% of sites and 28% of data points at sites (= 2.8% of all data review). Not because statistical or “reduced” Source Data Verification was better practice or science, or because a magic algorithm was found that could assure quality of data points not verified, but primarily to reduce cost and reduce the occurrence and duration of monitoring visits.
Remote Source Data Verification (rSDV) is a well-‐defined task within our industry by Sponsors, vendors and sites, but is a relatively new practice that due to its infancy has a multitude of definitions and applications. The practices proposed, explored and piloted, range from reviewing fax transmitted source documents to video recording and archiving patient visits. The term remote Source Data Verification needs to be both defined and standardized across the industry to create a common and targeted dialog that explores the impact of different practices and technologies on both cost and achievable data integrity.
The Clinical Trials Transformation Initiative (CTTI) surveyed academic/government/collaborative groups, CROs, Device, and Pharmaceutical Companies to better understand current monitoring practices in October 2009. They found that the frequency of onsite monitoring visits varies across the various groups conducting clinical research. Academic and Device organizations were less likely to do onsite monitoring visits. Only 46% of Academic, Government, and Cooperative groups visited a site more than once a year and only 63% of the Device organizations visited a site more than once a year . More than 80% of the Pharmaceutical and CRO responders reported performing onsite monitoring visits more than once a year. A small percentage of the responders in all groups reported using a centralized monitoring process to guide, target, or supplement site visits (23-33%). These organizations all report that more than 50% of the trials they manage are pivotal registration trials (Phase I, II, III) and the majority have more than 50 sites (with the exception of device organizations, where >90% of the studies have <50 sites). Interestingly, the most common factor for determining monitoring frequency was listed as study design for all groups. Academic groups also reported usual practice as an equally common factor in determining frequency of onsite monitoring trips.
Therefore, it can be concluded that a large number of trials that are critical registration trials are not thoroughly monitored and the welfare of subjects is not listed as a top reason for the determination of monitoring frequency. Budget and study populations were the least common factor in determining the frequency of onsite monitoring visits.
Key Areas included in this webinar
- Innate weaknesses of onsite monitoring
- Advantages of remote monitoring/rSDV
o Increased accuracy
o Reduced time to submission
o More focus to enhance CRA activities
o Cost savings
o Improved recruitment
- Internal change management required
- Advantages of rSDV to fulfil ICH E6 adendum
- New Job functions required
Keywords: Remote Monitoring, Source Data Verfication, ICH E6