Data Collection
Clinical Trials
Virtually all sponsored clinical trials have specific requirements for data collection. These are outlined in the study’s case report form(s), or CRF.
Investigator Initiated
Data may be entered into a specially created project data base
REDCap is becoming more popular as a quick way to create a data collection tool
Most Investigators use a simple Excel file to gather and compile data.
The HHC IRB requires that a data collection form be submitted with each application. This is usually:
- The CRF(s) for sponsored clinical trials;
- a REDCap template; or
- an Excel sheet, with the variables (field headers) in the first row.
Whatever format used – the goal is to collect data that are unambiguous and amenable to analysis. Some issues to be considered to maintain excellent data quality include:
- Consistency of column formats, i.e., numerical, text, specialty fields like dates
- Consistency across coders
- Using categories with sufficient data; e.g., there’s not much sense collecting “other” or “missing” if it accounts for much of your data
- Treatment of missing data
- Text data – use structured data (versus free text) if and when possible
- Test runs – consult with whomever will be analyzing data after the first few cases
- Need for HIPAA compliance; need to protect/secure protected health information (PHI) to the greatest extent possible
Detailed instructions and tips on building data sets can be downloaded here.