By: Linda Peterson (Vice President, Clinical Operations) and Sarah Schaul (Clinical Trial Manager, Clinical Operations)
Every business requires a solid foundation for success. The same idea applies in clinical research. A successful start-up is paramount to success in study operations. There are a multitude of innovative strategies, methods, and tools that Global implements to ensure that a solid foundation is built right from the start. One aspect of study start-up is planning and ensuring a study-specific infrastructure is built to comply with applicable regulations and guidance. To do this, there are several tools that can be utilized to track considerations for success, not only at start-up but, throughout the entire study. Here are a few that Global uses and a good place to start planning your foundation:
- Key Performance Indicators (KPIs), Key Quality Indicators (KQIs), and Key Risk Indicators (KRIs) Tracker
Key Performance, Quality and Risk Indicators are all tools to provide oversight on objectives and to understand how each area is performing. Part of oversight on these indicators are metrics, which are a quantifiable measure used to assess the status of how successful an activity may be for a given objective. In this type of tracker, we measure performance, quality, and risk objectives. To begin, it is a good idea to start with a discussion with the applicable study subject matter experts (SMEs) for the area you are looking to evaluate. To do this, start with a list of objectives for your study and each type of indicator (ie, performance, quality, and risk). For each objective, identify a way to measure how the objective is to be met. Along with the measure value, it is important to also provide thresholds of acceptability for these objectives and identify what actions should be taken at each threshold level. It is a good idea to have a visual representation by color coding threshold levels (ie, green = good, yellow = cautionary, red = poor). Other key pieces of information that should be added for each objective include the following but are not limited to, the formula for determining the threshold, frequency of review, performance tracking, the owner, and related actions.
- Risk Management Tracker
Along with maintaining KRI metrics, it is also important to setup a risk management tracker that should be reviewed and discussed, by the team and applicable SMEs, regularly throughout the duration of a study. A risk management tracker is typically setup based on a particular rating scale outlined in project plans and/or standard operating procedures. This tracker can include a study and number identifier, a description of the identified risk and date identified, the type of risk, the risk level based on the applicable rating scale (ie, minimal, moderate, high risk), a mitigation strategy, and any other pertinent information that may come up in discussion with applicable SMEs.
- Actions, Decisions, and Issues (ADI) Log
An ADI log is a key tool that should be set up at the start of a study and maintained throughout the life of that study. To learn more about the advantages to a well-maintained ADI Log and the items that should be tracked for each ADI, check out our white paper where we share tips for success.
- Frequently Asked Questions (FAQ) Log
At each stage of a study new questions often come in from the site, project team, vendors, and others. Sometimes these questions require additional follow-up and information from an applicable SME(s) or the client/sponsor. To ensure answers are consistent, an FAQ log can be a helpful tool. Items tracked in an FAQ log may include: the question category (eg, investigational product, safety/pharmacovigilance, unblinding, randomization), the actual question being asked, the answer, who answered the question (including their role/title/organization), and when it was answered. It is important to ensure that the answer to the question is verbatim to the response, and that the respondent is aware that it will be utilized for the current question and all future questions that are the same.
- Lessons Learned Tracker
As the study progresses, it is important to continually reflect and consider more efficient processes or ways of handling different situations, while remaining in compliance with applicable regulations and guidance. It is helpful to track improved efficiencies and solutions to problems to ensure that they are communicated to all new project staff (as applicable), and to ensure consistency across the study. This tool may be used at the conclusion of a study to discuss improvements and potential new ideas.
Keep in mind that some of these tools are essential, while others serve as more of an aid to ensure consistency, efficiency, and compliance throughout the duration of a study. We’d love to hear from you if you have any questions or are interested in learning more about the unique approaches that Global’s Clinical Operations Department utilizes to build a solid foundation.
Recent Comments