With risk based monitoring gaining importance in the clinical trials and with the release of the FDAs directives, it has become imperative to implement RBM strategies in each stage of drug development.
Apart from learning the important aspects about fool-proof implementation of the RBM, you need to master the art of laying down an effective Risk based monitoring plan. RBM plans vary with every research/study.
Need to Develop a Risk Based Monitoring Plan
We need to develop the risk based monitoring plan since it helps to identify various plans that form a part of the drug development. It helps to justify, if the process is rationale enough to use.
Ensure the Following Steps
- RACT Completion to Monitor the Quality of Risk Assessment
- Identification of Key Risks Involved in the Study
- Deriving Analyzing Parameters from Risk Parameters
- Writing the RBM Plan Considering Above Steps
- Having RBM Change/Adjustment Plan Ready
Tips That Would Help You Create a Workable RBM Plan:
- FDA suggests that the clinical operations and their personnel in their risk monitoring plans must describe how to leverage insights in the clinical trials. These studies must be tailored for individual studies.
- The RBM plan must help the personnel to interpret and analyze the data set to improve the quality of the clinical trials.
- Traditional monitoring earlier used to record only plans purpose and training activities, but with risk based monitoring technological, statistical, global and risk based perspectives are also highlighted, so we need to prepare our data in that fashion.
- Make sure you have all the additional details such as qualitative & quantitative monitoring.
- The plan should detail how CRAs can communicate the monitoring results.
- A RBM plan must help to analyze the IT system and their capabilities to evaluate the clinical protocol’s study sites and staff skill sets as well.
By following the aforementioned tips, you are sure to have a well-structured risk management monitoring during any type of clinical trials.