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Lecture 7
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HC7 van Clinical Trials and Clinical Development
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Lecture 7 Vrijdag middagQuality management
Biggest change in the R2 is the quality management
Quality management is CH 5.0 and the responsibility of the sponsor
Why the R2 Addendum?
Because of new technology the sponsor is able to run data analysis before DBL, but is not
allowed to because this can introduce bias.
We do risk analysis between different countries and regions, to find out if some data deviate
significantly and to find out if somewhere something is going wrong.
If a particular site has particular lower or higher AE
With great power comes great responsibility (peter parker) -> new technologies, do not do
things that can introduce bias.
-New opportunities to increase efficiency & focus on relevant activities
-Evolutions in technology
-Risk management processes
-Centralised monitoring offers greater advantage; you can see if there is a AE and check if
the treatment matches with the AE.
-Early access to trial data
-Running risk analysis
ICH-GCP R2 Addendum
Risk based monitoring is monitoring on the site where you have an indication for risks and
therefor lower quality data
Root cause analysis = RCA
Corrective and protective Action Plan = CAPA
Since we have electronic data, the problem with this is that the investigator has no control
over the data while downloading.
-Quality management
-Investigator oversight
-Dealing with Non-compliance, RCA, CAPA
-Sponsor/CRO oversight
-Electronic record keeping
-Essential docutments
-ALCOAC
-Monitoring plan
-Control of data
Required quality management process steps
1
, Critical process & data; we analyse this early on to see if data is critical
Risk Identification; the risks of the above data points going wrong are they at system level or
at trial level?
Risk evaluation; how high is the risk, which is more important?
-Impact
-Probability
-Remedial action; what can you do when things go wrong? -> ICH = Detectability; is
anything goes wrong can you detect it?
-> Triangle, assign the scores on the axis and calculate the surface; this is your risk
Risk Control; two things we can do; choose to accept it, or choose to reduce it and do risk
reducing actions. Predefine quality tolerance limits
Risk Communication; Quality management plan, this is high risk, it is important that we get it
right. Facilitate review, it is a continuous process
Risk review; continuous review of risks, quality tolerance limits, emerging knowledge
Centralised monitoring; review, that may include statistical analysis, of accumulating data
from centralised monitoring can be used
Risk Reporting; predefine the risk as much as you can, but keep the list updated during the
trial. The CSR should include; quality management approach, important deviations form
tolerance, remedial actions
Quality control, quality assurance & site audits
SDV = Source Data Verification
QA vs QC
QA = Quality Assurance; audits that are being done -> complete def. see slide
All those planned and systematic actions that are established to ensure that the tirla is
performed and the data are generated, documented, and reported in compliance with GCP
and the applicable regulatory requirements
QC = Quality Control; maintain quality = monitoring -> see slide
To make sure that it is compliant to GCP, regulatory control and no fraud
The operational techniques and activities undertaken within that quality assurance system to
verify that the requirements for quality of the trial-related activities have been fulfilled
QA is a snapshot in time
Figure 1 Quality control
2
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