For logistical purposes, data can be considered to fall into one of three categories: administrative data, regulatory data, and research data, which are shaped by the data and study design of the research project. In setting up the data collection systems, be mindful of the needs of the study as well as the reporting requirements of the funding agency. For guidance on how to set up and maintain simple or complex data systems, consult a CTSI research facilitator.
Administrative Data
Administrative data encompass the “nuts and bolts” information needed to support research efforts. In a clinical trial, for instance, at a minimum you’ll need to collect contact information for all participants—names, addresses, phone numbers, E-mail addresses, and the like. Keep in mind that research ethics and federal and institutional regulations dictate that such administrative data be stored securely and separately from research data. That way, in case of a security breach, there is no way to connect individual-identifying information (administrative data) with personal health information (research data), thus maintaining patient confidentiality. (For more information on patient confidentiality, see the Health Insurance Portability and Accountability Act [HIPAA].) Having an organized system for maintaining and retrieving administrative data is even more important if your project is a large one that spans multiple institutions.
Regulatory Data
Regulatory data include all the forms and information needed to comply with institutional, governmental, or funding source requirements. The amount and type of regulatory data will depend on the variables and the nature of the research project. Remember that periodic updates and reports of regulatory data will be required and, thus, it’s essential to properly and accurately document all data that will be needed to complete these reports. (For more information, see Research Regulatory Issues.)
Research Data
Research data entail all the information you’ll need to gather to address the hypothesis put forth at the outset of your study. Determining what data you’ll need—and, just as importantly, what data you won’t need to accomplish this goal—is not always a simple matter. (No doubt, you’ll have dealt with this issue in crafting your grant application, but if not, now is the time to do so—or to revisit your data and study design.
Remember, to avoid the risk of completing a study and discovering that your data are useless, always engage the help of a biostatistician early in the planning process for your research. Allow at least two months for consultation and study design assistance. Doing so will help to ensure that your data collection methods, parameters, and statistical analyses are appropriate to address your research question. Likewise, a biostatistician can help you avoid undercollection and overcollection of data, both of which carry their own pitfalls. (If you don’t know where to go for statistical advice, contact a CTSI research facilitator.)
