An important part of the research planning process is the development of a data management plan that specifies how data will be recorded, organized, reduced and analyzed. This plan begins with the research proposal, specifying the research question, hypotheses and design. Before any data are collected, the researcher must be able to identify what variables will be measured, using what instruments and units of measurement. Those who will collect data may need to be trained and reliability assessments done. Undoubtedly, some of these plans will change once the project has begun, but nothing should begin without a firm plan in place. This planning requires knowledge of data coding and format requirements, statistics and computers. The purpose of this chapter is to describe procedures for setting up data to be entered into a computer and analyzed with statistical programs.
CONFIDENTIALITY AND SECURITY OF DATA
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 and secured 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 only be accessed 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, who will have access to records, and what safeguards have been put in place for security and confidentiality (see Chapter 3). 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 In Canada, they are incorporated into the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.2
MONITORING SUBJECT PARTICIPATION
Throughout the project, researchers should have procedures in place to keep accurate and complete records of subject involvement. Records should indicate how many subjects 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 noted if possible. Changes to the research protocol must be described. 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 (see Chapter 9).