All scientific research, be it basic, clinical, or translational, is driven by data. Without the factual information and insights that can be gleaned from data, there’s no way to support or refute a hypothesis and, therefore, no way to measure the research outcome. However, before data can be analyzed for results, appropriate collection and record-keeping procedures must be planned, established, and followed. If a biostatistician has not already been engaged in the process of determining the specifics of data collection for your project, now is the time to do so—or risk the possibility of discovering later that your data are incomplete, irrelevant, or inconclusive. For more information, see Data Collection and Record-Keeping. While establishing your data collection and maintenance process, here are some fundamental questions:
How will the data be collected?
If by PC or laptop, does the equipment have adequate memory, speed, and storage capacity? Is the most appropriate software being used?
Are adequate security measures in place for data entry, access, and retrieval?
Have any forms to be used for the study been designed to capture all of the data and information stated in the protocol?
Have the data collection forms been pilot tested with the data management system?
For clinical studies, what questions will be asked of the study participants?
Will research team members have a private space in which to meet with study participants?
If a survey is to be used, has it been validated (broadly tested and found to elicit the appropriate information)? If not, is the survey designed to elicit data that are statistically analyzable?
Are printed surveys or questionnaires formatted to be easily read and understood by the target audience? Are they approved by the IRB?
How much time is required to complete the form?
How will the paperwork be handled and compiled as it comes in?
Who will be collecting the data?
Who will be analyzing the data?
Will you need a databank, database, or biospecimen repository?
Are all pertinent regulatory issues affecting the collection and maintenance of data being addressed?
Where will the data be stored, and is there a “double-lock” system in place? (Note: All research data must be locked down somewhere that provides a double level of security in order to safeguard the integrity of the data and, in the case of human subjects, to protect confidentiality. Examples of a double-lock system include having the data on a password-protected laptop and then storing the laptop in a locked room, or having data locked in a cabinet in a locked room.)
Do you know what help with any of these issues is available from CTSI and how to access that help?
