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Data management principles.* |
| General |
| □ Carefully plan data management well ahead of data collection [2,5-8]. |
| □ Check for problems early, while it is still possible to correct them [5,8]. |
| □ Provide staff with appropriate training [3,8,15]. |
| □ Provide clear lines of authority and responsibility [18]. |
| Data collection instruments |
| □ Pre-test all data collection instruments [6,18]. |
| □ Include the version number and date on each form [17]. |
| □ Label measurement units on data collection forms [17]. |
| □ Develop mock tables for results and fill them in with elements from data collection forms to ensure you are collecting all the variables you need [13,14]. |
| □ Focus efforts on the variables needed for the primary analyses [5,8]. |
| □ Develop a detailed procedural manual for data collection [8,15,18,24]; keep a log of all decisions that alter procedures. |
| □ Use a specific code to indicate data elements that are intentionally blank [4]. |
| Data security, entry and cleaning |
| □ Double-enter and verify all data [3-6,9,16]. |
| □ Develop a data dictionary, including allowable and in-range responses [4-6,15,18]. |
| □ Store both paper forms and computerized data securely [15,24]. |
| □ Back up computerized data files regularly [5], keeping offsite copies to safeguard against a system failure [4,15]. |
| □ Thoroughly check data for missing or potentially erroneous items [1-3,5,8,9,17]. Strategies for data checking include range and consistency checks [1-3,5,8,9,17], checking for missing data [3,5,9,17], between-form consistency checks [2,5,8,9,17], comparing forms to check whether they were collected in the proper sequence, whether forms were entered more than once [16], and whether entered forms matched up with the management database [4]. |
| □ Never obscure or destroy original data; maintain a clear audit trail of all changes to the data [2,5,8,9,15,17]. |
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*Additional regulations that apply to data integrity and security have been enacted since the time of our study. The Health Insurance Portability and Accountability Act (HIPAA) [25] addresses the security and privacy of health data, and 21CFR Part 11 [26] specifically addresses the reliability of electronic records. |
Kruse and Mehr BMC Medical Research Methodology 2008 8:61 doi:10.1186/1471-2288-8-61 |