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Table 2 Data management principles.*

From: Data management for prospective research studies using SAS®software

General
   □ Carefully plan data management well ahead of data collection [2, 58].
   □ 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 [36, 9, 16].
   □ Develop a data dictionary, including allowable and in-range responses [46, 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 [13, 5, 8, 9, 17]. Strategies for data checking include range and consistency checks [13, 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].
  1. *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.