A successful career in clinical research requires attention to detail and accurate data. The data that is generated by research is incredibly valuable and will help ensure proper analysis of that research. Your data collection strategies will help you in this effort. Collecting and analyzing statistical data will be a skill that you leave your program with and it can directly apply to your work in the field.
Data can be collected using Paper Case Report Forms (CRFs), Patient Reported Outcomes (PROs) or by electronically capturing the data with Electronic Case Report Forms (eCRFs), among other strategies. All methods hold their advantages and disadvantages, and you may find that you use a combination of these throughout your career. Read on for more about data collection in clinical research.
1. Using Paper to Collect Data in a Clinical Researcher Career
As our world becomes more technologically advanced, it can come as a surprise to hear that paper reports are still quite effective in certain cases. With hard copies of handwritten data in Paper Case Report Forms (CRFs), researchers don’t need to have access to a computer when they are engaged in research and can simply bring Paper CRFs with them wherever they need to work. The data from these forms are then entered into a computer for digital storage.
Paper forms still hold advantages, such as not needing computer or device access during data collection
Unfortunately, paper isn’t the greenest method of data collection and takes up more space than digital files. Also, since information from paper forms is eventually entered into a database, this creates an extra step and more margin for human error. With digital methods, this extra step can be automated.
Thankfully, handwritten data doesn’t have to be completely incompatible with digitalization. Some studies use Optical Character Recognition, or OCR, to take information written out by hand and automatically generate a database from the staff’s handwriting.
2. Digitalization of Data Collection After a Clinical Research Program
If you’re entering a new career after your clinical research program, you will likely notice digitalization everywhere. CRFs evolved from paper to electronic forms, and now eCRFs are used frequently. This method requires researchers to have access to computers on-site, which can be difficult depending on the nature of the study. Digital records can be automatically backed up or added to databases, so they hold an efficiency advantage over paper methods.
eCRFs also require audit trails, which are a way to trace all changes that are made to documents. They also need to be password protected and have users authorized to prevent tampering with the data or results. Digital data collection can also work to ensure accuracy. Entry errors can be flagged if detected by the system, shrinking the margin for error.
Digital data collection also enhances diversity as it facilitates communication with underrepresented populations who otherwise are less likely to participate in research due to barriers caused by age, geography, or disability.
3. Patient Reported Outcomes in Clinical Research
In many cases, patients directly supply data to researchers, such as by answering questionnaires and surveys. You may find this useful in a clinical researcher career for gathering more in-depth and timely feedback.
These documents are called Patient Reported Outcomes, or PROs. Sometimes patients will continue to provide data off-site, through electronic methods. These can be more useful to researchers than paper, as they provide ongoing information instead of only providing info when the patient is on-site and has brought their paper documents with them.
Patient data that is provided electronically can remove geographical barriers
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