If the process for data collection was not addressed in your grant application, then the next step is to determine how your research team will gather the data needed for the study, whether it is basic research data generated by laboratory experiments or clinical research data from interactions with study participants. For large and complex studies, especially, a statistical consultant should have been on board the project from the beginning, when the study was being designed and the grant application being written. However, if that didn’t happen, there’s still time to correct the situation and consult a research statistician.
If data collection methodology was addressed in a grant application, now is a good time to revisit the plan to ensure that it is still viable and, then, to establish a workable process for data entry and management.
- Will you first gather information on a paper case report form and later enter numbers into a computer database, or will you have a central data entry process?
- What about the use of hand-held electronic devices such as a personal digital assistant, or PDA?
- Who will gather and enter the data—work-study students, staff nurses, the clinical research coordinator, professional data entry operators, the principal investigator?
The answers to these and other data entry and management questions depend on various factors, including level of difficulty using measurement tools, margins for error, complexity of computer software systems, time intensity, and, of course, the budget.
Be sure to delineate who on the research team will be responsible for collecting and entering data. The person who collects the data may not be the same person who inputs the data or interprets the data, so unless clear expectations are established at the outset to determine who will do what and when, data logjams can easily occur, delaying and possibly even derailing a study.
