Systematic and streamlined data management processes are critical to successful data analysis. The development of standardized data collection forms is then an important strategy to utilize in accomplishing this goal. Ideally, data collection forms will facilitate the consistent recording of data, in both paper and electronic source formats.
Well-designed data collection forms should not only identify the data to be collected, but also any relevant parameters around that data. For example, should weight be measured in pounds or kilograms and recorded to what decimal place? Should blood pressure be measured on the same arm at each visit, or can the assessment arm be varied? Are timed tasks be recorded to the nearest second or millisecond of duration? Consistent recording of data will reduce time-consuming data manipulation prior to analysis.
Data collection forms should also assist the study team in maintaining compliance with both protocol requirements and with data collection standards. Forms should be built to guide the collection of data in the required sequence of events, and under the required conditions as applicable. If the protocol requires sitting blood pressure to be collected after 5 minutes of rest, followed by an immediate standing blood pressure, a purposeful form would appropriately sequence the data collection procedures and include pertinent instructions for the data collector. Further, the form should prompt collection of information regarding who performed the procedure and recorded the data, in accordance with the ALCOA principles of good documentation practices.
An expanded set of commonly used data collection form templates has recently been made available on the IU HRPP Website. Available templates now include, but are not limited to, subject demographics, eligibility, medical history, physical examination, vital sign assessment, concomitant medication log, adverse event log, protocol deviation log, and drug and device accountability forms. Template forms are intended to be modified by the study team to more specifically support a particular study’s needs. Additional forms may be need to be developed in order to complete your required set of data collection tools. Consultation with a statistician and a developer for your preferred data management system are encouraged during the form development process.