What a difficult question? After all, quality has been mainly the responsibility of quality managers, and now project managers should also apply an RBQM?
Of course you will still have the support of QA, but as a PM you have a crucial role to play in ensuring that quality risk-based approaches are put in place. It starts with reviewing the protocol to see if all the procedures are feasible, what the risks are (central lab, sample shipments, patients not showing up, etc.), discussing with the data managers what the risks are for data collection, checking with all the countries/sites what the standard of care is and if the study procedures seem feasible to them. In other words, what are the potential risks and challenges. But please also involve patient representatives. They can be very informative about the results (answering their questions), whether the trial is too burdensome, or how to overcome challenges such as getting to the sites regularly, etc. Patient representatives are not just advocacy groups or patient groups, they are patients from the field. As such, they will improve the quality of your protocol and the quality of the data collected. Indeed, discussions with patients can help you to identify risks related to recruitment, data collection (missing visits), etc.
Risk proportionality also means that you can adapt the training strategy by stakeholder and reduce it to what is specific, not repeat the same thing over and over again. People who only do standard care do not need to be trained in the trial.
The same idea is for the drug accountability or medical device accountability for the ones already on the market and used as approved, then there is no need of a complicated tracking of medication/medical device.
In case of decentralised studies, please also think about what is standard of care and usual practice and how your study can fit to it in order to reduce the workload and improve the patient adherence.
These are principles that you should continue to apply during the study when issues raised, new protocol amendment should be submitted etc.
Do you have any question on that? I am sure you still have. WOuld you like that I am training you on this topic in a webinar?
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