23 5.4 | Data Security and Integrity

Ensuring the security and integrity of research data is of the utmost importance to maintain participant confidentiality and data quality. Some general policies regarding research data are as follows:

• All data must be kept confidential. Do not share any data or information regarding subject participation with anyone who is not listed as a co-investigator on the IRB-approved protocol.
• All data should be de-identified. Subject names or other identifying information should not be included on data forms.
• Follow the study protocol as written, without exception. Deviations must be reported to the IRB. If a deviation occurs, please contact Dr. Swiezy and Dr. Neal.
• If collecting data off-site, make sure the data
  remain with study staff at all times. Data should be transported in a locked case. Do not leave data in your car or unattended in any public area.
• To ensure security of data, all data should be stored in locked cabinets. Never throw anything away that has PHI or other identifying information on it.
• Use your computer’s lock function under the Start button when you leave your work area to ensure that unauthorized individuals do not have access to the data. Never share your computer passwords.
• When collecting data, ensure that all research data are accurate and complete.

When in doubt, ask Dr. Neal, Dr. Swiezy or your coordinator!