OVERSIGHT Fact Sheet
It is a critical control point given that in many instances the IXRS® acts as an eCRF given it is the first point of entry and as such the source of data that is ultimately pushed to other systems (EDC, eCOA, CTMS) and can be used to investigate any potential discrepancies between systems or ongoing reconciliation activities during the trial.
OVERSIGHT Fact Sheet
DownloadData Integrity Guidelines & Regulations
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) revised guidance requires documented evidence on how the sponsor performed oversight of the study.
The Data Integrity guidance put out by the MHRA, FDA, and the current (2021) draft guidance by the EMA aimed to not only assure data integrity but to enhance and take a more proactive approach.
Audit Trail Reporting
Audit trail reviews conducted by data managers, statisticians, safety staff, and other roles can help identify data inconsistencies, outliers, and protocol deviations; plus any errors in data collection and reporting at a site or across sites; and other data integrity issues. It’s critical to be able to quickly see trends and issues, then drill down into the details to accurately analyze what the trends show and take necessary action.
How OVERSIGHT assists sponsors with ICH monitoring guideline compliance
In late 2016, and subsequently in March 2018, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued revised guidance (E6, R2) concerning sponsors’ responsibilities with respect to trial oversight.
As stated in ICH E6(R2), inspectors expect to see documented evidence on how the sponsor performed oversight of the study. Section 5.18.3 emphasizes the importance of centralized monitoring processes to “complement and reduce the extent and/or frequency of onsite monitoring and help distinguish between reliable data and potentially unreliable data.” Further, the Data Integrity guidance put out by the MHRA, FDA, and the current (2021) draft guidance by the EMA aimed to not only assure data integrity but to enhance and take a more proactive approach.
The audit trail is an integral part of any e-clinical system and should be utilized as a tool to drive data reviews forward. The Audit trail within the IXRS is a critical control point given that in many instances the IXRS acts as an eCRF given it is the first point of entry and as such the source of data that is ultimately pushed to other systems (EDC, eCOA, CTMS) and can be used to investigate any potential discrepancies between systems or ongoing reconciliation activities during the trial.
How can sponsors be successful at providing effective oversight to comply with regulations?
- First, sponsors need on-demand access to the data as the study progresses to be able to identify any risks or needed actions.
- Secondly, the data should be presented in a way allowing for ease of review. Both summary and detailed data views are important.
- The sponsor can then establish processes and procedures around periodic review and risk identification and remediation.
Event View
Provides a count by location for each IXRS® event, adjustment type (if applicable), and reason for adjustment/change.
Summary View
Provides the same data as the Events view, but breaks out events, adjustments, and reasons separately. This allows the user to identify trends by location, high/low performers, or any outliers.
Transaction Details
Provides a detailed view of all IXRS® events. Providing details such as: who performed the transaction, on what date/time, before and after values.
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