A risk is any uncertain event or condition that might affect your project. Not all risks are negative.
No single approach to monitoring is appropriate or necessary for every clinical trial. FDA recommends that each sponsor design a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
Not all risks are negative
Some events (like finding an easier way to do an
activity) or conditions (like lower prices for certain
materials) can help your project! When this happens,
we call it an opportunity… but it’s still handled just
like a risk.
Image Source: Head First PMP, by Jennifer Greene, PMP and Andrew Stellman, PMP
FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof”.
Unfortunately, a lot of people in the industry are speaking about risk-based monitoring, but few have a broad understanding of the whole life-cycle process. Great opportunities exist for savings, but then again, most EDC platforms dont work effectively with risk-based monitoring. Switching to risk-based monitoring increases rather than decreases work because it can break the EDC workflow – refuting much of the value of EDC.
In conclusion, Risk-based monitoring is yet another desperate attempt to deal with what all Electronic Data Capture (EDCs) systems have failed to deliver – quality of clinical data.
Source: FDA Guidance
Your comments and questions are valued and encouraged.
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica, Open Source and Oracle Clinical.