Sponsor Oversight Technology in clinical trials

A key regulatory focus in recent years has been for clinical trial sponsors to provide auditors evidence of the oversight of the execution of outsourced clinical trials.

From the EU Directive, a sponsors oversight responsibility can be summarised as;

Clinical trial sponsors are responsible for ensuring that their trials comply with regulatory requirements and the study protocol. This includes establishing processes to evaluate third parties who perform clinical trial-related duties. Sponsors must also ensure that the delegation of duties doesn't undermine the safety of participants or the reliability of the data.

Sponsor oversight naturally aligns with CTMS for defining and tracking oversight activities, and with eTMF for storing oversight evidence. However, the definition of oversight and how tech might be applied varies across vendors. What this actually means from a technology perspective is open to interpretation.

Below I list what I would define as the Minimum Viable Product (MVP) capabilities that a technology should offer to fully meet these regulatory demands.

1. Oversight Planning - Sponsor Oversight can only be measured when defined against a (risk based) oversight plan. Proof of oversight is only fully achievable if confirmed against a plan. A solution should support the definition of a plan that ideally highlights elements of the oversight that are covered by a computer solution versus those that are carried out manually and/or externally.?
2. Oversight Task Management - Sponsors should be able to independently confirm the achievement of a task or milestone as defined in the oversight plan in an ALCOA (+) form.?
3. Oversight Tracability - Based on the definition of the plan, evidence of oversight should be recorded. Based on a risk assessment - critical and high risk items should be fully supported by evidence.?
4. Oversight Meta information - Support the preparation of materials including KPI's that are the target of oversight reviews
5. Data Aggregation and Centralization - Support the aggregation of information from other systems that are required as part of overall oversight monitoring

Over-see not Over-do

It is crucial for the sponsor that oversight activities genuinely monitor the CRO's work rather than duplicate tasks. Repetition is not oversight. When sponsors perform tasks themselves, they need robust processes, including internal oversight, to meet regulatory requirements. If responsibilities are shared, it must be explicitly clear how the oversight function is appropriately divided.

Signed minutes as proof of oversight?

Historically, manual oversight has often been achieved through the use of project meetings followed by minutes that were appropriately signed/approved. These are not necessarily wrong, but they may not provide the level of assurance of oversight that regulators are looking for. For example, there is an assumption that the materials presented - either a Powerpoint or Dashboard are an accurate 'reflection' of the state of an item of oversight interest. However, these tools are often not fully validated and cannot therefore be used entirely as evidence.

Digital or Manual Oversight

As the complexity of systems involved in clinical trials increases, I would argue that the need for digital oversight as opposed to tracking through signed minutes, or via Word and Excel documents, has become more critical. For Sponsors, it is not just the act of overseeing what is presented to you in summary, but instead, overseeing the details as described in your oversight plan. This demands a good integration between a digital plan versus the execution of oversight against this plan.

Systems support

The fact that a system is capable of presenting information to a Sponsor is not sufficient proof that the sponsor actually looked at this information. Systems need to not only present the information, but to log the fact that the information was presented, and that the person assigned the role of oversight adjudicated the information.

Who's system?

If a sponsor outsources their study to a CRO, it is more than likely that the CRO will operate CTMS, eTMF and other clintech products as part of a set of tools and processes to provide their service. It is the CRO's responsibility to help support their Sponsors in meeting regulatory requirements. This includes providing all necessary support in enabling their sponsor to carry out oversight management. The question this then raises when thinking digitality is “how do you carry out and record oversight when the CRO holds the data and systems that execute the clinical trial?”

I will present the case for and against recording oversight in CRO and/or Sponsor clintech in my next blog.