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Managing Human Subjects Research Projects: A Tool Kit for Project Managers

6. Finalizing Data Collection

6.1 Collecting Post-Interview Data

For some projects, there is a need for post-interview data collection; data that have been previously obtained (secondary data) are needed to answer the proposed research questions. A few notable differences for using secondary data are described here.

  • Budgeting for secondary data collection should always be considered. Secondary data collection is not always less expensive than primary data collection. Project managers should plan ahead for the possible use of secondary data and budget appropriately for purchasing or accessing the data, as well as for preparing the data to be compatible with the current study.

  • Terms and Conditions for purchasing and using secondary data vary widely. It is important to clarify whether the data are free, can be purchased and owned by the project, or are allowed to be used only for specified purposes dictated by the contract.

  • Access to the data is also a consideration. Some secondary data are easily accessible in multiple formats and can either be directly downloaded by or sent to the research team. Other datasets require a programmer or researcher to obtain permission and travel to a secured site. This person may be able to perform analyses on the data only within the secured site. Consequently, the results of the analysis belong to the project, but the data used to obtain the results remain secured. In other cases, the researchers are not allowed direct access to the data but make their request to the source and are charged for the analysis. Most places with large datasets that obtain personal identifiers and personal information have a method for restricting access that is intended to guard the confidentiality of the information. The method that is used has associated costs and time considerations for the project.

  • Documentation that describes how the secondary data were obtained and cleaned, whether any variables were created, and the method used to create those variables should be provided by the project manager. The research team will need to provide additional documentation that describes their review of the dataset, as well as decisions that were made regarding inclusion, exclusion, and aggregation of the data in creating variables. This process can be extremely time consuming but is vital in describing how the analyses were conducted.

When budget and timeline decisions about the use of secondary data are being made, they should be conducted in consultation with the programmer or researcher who has the most in-depth understanding of the data variables and analysis of the project. The project manager's role is to reflect these needs in the budget and timeline. In addition, the data acquisition process and obtaining the correct forms, signatures, payments, etc. may be the responsibility of the project manager.

6.2 Preparing Final Deliverables (Data File Preparation)

The objectives of a research project will be defined early in the study's creation and development. These research objectives will be translated into database creation and maintenance, where the structure and format of the data collection and entry will be consistent with the research objectives and statistical analysis. (For example, if one of the research objectives of a project is to analyze the health perceptions and behaviors of minority males, the data collection instruments used in the project will capture the sex, race or ethnicity of the subject, and include questions involving the health status and opinions of the individual.)

Once data have been collected according to the study criterion, the data will need to be prepared for analysis and interpretation. For the purposes of this section, it will be presumed that data have been collected in a consistent and uniform manner, and once entered or transcribed into a database package, have been subject to a basic level of consistency and verification.

There are three primary areas of data analysis preparation: 1) developing a comprehensive data dictionary or codebook; 2) performing rigorous data quality checks to ensure data accuracy and consistency; and 3) performing summary statistics on the data to document the data content and structure.

6.3 Preparing a Final Methodological Report

A final methodological report will provide investigators and project managers with detailed information about management of the project. The methodological report should include an overview of the study, study design, sampling plan, questionnaire and data collection protocol. In addition, the methodological report may include details about the pretest, main study, data cleaning and processing, a final disposition of samples and sample rates and study limitations. Methodological reports often include all final forms and/or questionnaires used in the fielding of the research study.

6.4 Reporting Study Outcomes

Typically, outcome data are reported by the project PI; however, in some cases, project managers may be allowed to report on some aspects of the study findings via scientific conferences, community symposia, and published manuscripts. Regardless of the mechanism through which study outcomes are reported, it is important to portray the target audience in a way that reports the data accurately, and not offensively. Ultimately, the PI makes the decision about when, where, and how to report the study outcomes. The project manager can be an integral part of this process. Be sure to review Section 2 of this document for tips on reporting research findings to the community.

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