The importance of good record-keeping and quality data control is as applicable to clinical research as it is to basic research. The fundamental principles of data collection and management used for basic research can be adapted for clinical research, bearing in mind that the procedures followed can affect the validity of the research results.
Common pitfalls during the data collection stage of clinical research include protocol deviations, subject noncompliance, improperly made observations, improperly entered data, and improperly stored data. As much as possible, keep the experiment design and the intervention simple. Do not stratify, randomize, blind, or allocate subjects unless necessary (as deemed by your statistician or solid statistical reasoning). The fewer procedures, drugs, tests, and visits built into your study, the more subjects you will retain. Although you will want to gather enough data to give your analysis sufficient statistical power, resist the urge to overcollect—the more numbers you have, the greater the likelihood of a mistake somewhere along the way. Prepare standard, detailed, and comprehensive manuals for how you expect the data to be collected and provide instruction and training for all staff members involved in the effort. Make use of pretests, dry runs, and pilot studies to iron out kinks before embarking on full-scale data collection.
During the data collection process, check in frequently with staff to address any ambiguities. Audit the charts yourself to make sure that all appropriate forms (informed consent and others) have been completed. Perform periodic inspections of sites where drugs are kept, checking for proper labeling, storage temperature, and expiration date.
An obvious concern for clinical research is generating enough interest in the study to produce adequate data. Direct-mail solicitations, media advertisements, or direct contact with health professionals are ways to promote interest and participation in clinical studies. Another valuable source of assistance in participant recruitment is the CTSI Research Participant Registry, which is a voluntary database of people who are willing to consider participation in research studies.
