By Adam Wood, VP, Business Development at myClin
Mistake #5: Lack of training on what constitutes evidence of Oversight
Even in organizations with low staff turnover, a common clinical trial staffing pattern is that the staff who represent a company in an inspection are not the staff who started the study — for example at the protocol design and site identification stage. This is understandable because to an extent the skill sets and expertise that are optimal at earlier stages are different to those needed later.
Unfortunately, it is all too common for those trial leading staff in the early and middling periods of the trial — when pressures over protocol completion, site initiation and patient enrolment are at their highest — to struggle to pay enough attention to what constitutes evidence of oversight.
The other side of this coin are the staff who join a study team in the build up to an inspection. It is often incredibly hard for them to fully comprehend “the story of the study”. Information is strewn across multiple locations. The evidence is dispersed and at times contradictory. The record of processes and decisions from the early days of the study is lacking. How do they get to grips with what happened during the study — some parts of which happened years ago.
Imagine you are in this scenario in 2021……
- You are hosting an inspection about a study you closed out in 2019
- The inspector asks for: “evidence that the research nurse at site 12 was trained on the 2nd protocol amendment before they enrolled patient 5.”
When I presented at a recent conference I posed this question to the audience. Being admirably frank most of the audience noted that it might take them up to an hour to find this evidence — and for some it would take them even more than an hour.
Hardly a positive example of your oversight evidence especially as there alternatives available now [Editor: shameless commercial plug coming….] such as the myClin Clinical Oversight Platform. In that situation:
You were smart – and you chose to work a little differently in 2018-9.
Within seconds you open the compliance record in your Clinical Oversight Platform for that 2nd protocol amendment.
There is your evidence that the nurse was trained!
[End of commercial plug – phew!]
Moving on, it’s important to prepare your inspection team well before an inspection and to establish in-house roles and responsibilities for when the inspector arrives. Internal mock audits are a great way to get a feel for both your team’s strengths and weaknesses and also the strengths and weaknesses of your oversight evidence base.
An additional point relates to the sponsor obligation to ensure sites are trained and competent in the procedures for your study.
ICH E6 R2 says:
Training evidence takes a number of forms:
How do you track the delivery of this training and information. Bear in mind that that ad hoc content is often of the highest, most critical value in terms of good study execution and therefore Oversight.
We hope this review of common mistakes in clinical trial inspections has been useful to you. Good luck with your next inspection!