An important part of the research planning process is the development of a data management plan that specifies how data will be recorded, organized, and analyzed. This plan begins with the research proposal, specifying the research question, hypotheses, and design. These plans will also translate to the data analysis section under methods in a research report. It is not unusual for these plans to change once the project is under way, but nothing should begin without a firm plan in place. This planning requires knowledge of statistical programs, data coding and format requirements. The purpose of this appendix is to describe the process of data management. SPSS will be used to illustrate the process, consistent with the presentation of statistical output throughout the text.
Confidentiality and Security
The research proposal will include a plan for handling data, including maintaining confidentiality of participant information. All subjects should be assigned a unique ID number that is not related to their name, medical unit number, Social Security number, or other personal identifier. Documents for data collection should include the subject ID only. A list of subject names, addresses or phone numbers and corresponding ID codes can be kept separate from other files in case participants need to be contacted.
As part of informed consent, subjects should be assured that their personal information, data from medical records, and data collected as part of the project will be accessed only as necessary for research. The institutional review board (IRB) that approves the project will want to know the type of data to be collected, the purposes for which the data will be used now and in the future, who will have access to records, and what safeguards have been put in place for security and confidentiality (see Chapter 7). Many countries have regulations in place that define these standards. In the United States, these are part of the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA),1,2 and the Common Rule.3 In Canada, they are incorporated into the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.4
Monitoring Subject Participation
Throughout the project, researchers should have procedures in place to keep accurate and complete records of participants’ involvement. Records should indicate how many participants were recruited and why some were not eligible, how many agreed to participate, and how many eventually did participate. Attrition should be monitored and reasons obtained. Initial group assignments and deviations from these assignments should be documented. This information is relevant to the validity of the project and will be important if the researcher wants to complete an intention to treat analysis. This information should also be accurately reported in a flow diagram, including reasons for drop-outs (see Chapter 15).
Depending on the type ...