1. STUDY MANAGEMENT Cathy S. Berkman, Ph.D., MSW Fordham University Graduate School of Social Service

2. Overview Scope of Study Management Organization and Procedures Staffing and Personnel Issues Manuals Budget Study Management Database Interviewers: Hiring, Training, Supervision Ethical Obligations to Staff Issues Specific to Longitudinal Studies Editing and Coding Data Quality

3. Good research requires… Properly conducted study  Focus of this lecture Worthwhile research question Clearly defined study aims Well-designed methods Appropriate and complete data analysis Well-written report

4. Goal of Study Management The quality of the data can be seen as the keystone of a project’s success, and perfection should be the standard to strive for on all levels of the operation. Stouthamer-Loeber & van Kammen, 1995 Ideally, one seeks an error-free study rather than merely control of the errors. Marinez,et al. 1984

5. Study management includes… Management of study procedures  Sampling  Recruiting and enrolling subjects  Data collection  Management of paperwork Management of personnel  Hiring  Training  Supervision  Scheduling Management of costs

6. Study management … Starts with the conceptualization and planning of study Should be considered as you plan each component of the study Continues until the last paper is published

7. Study management is very time consuming Not adequately addressed:  Often not taught in doctoral programs  Relatively little written information on “how to”  Inadequate provisions in study budget Study Management (cont.)

8. Size of the study will affect the complexity and division of labor with respect to study management tasks  # of subjects  # of sites  # of staff  # of dollars But the same study management functions are required for every study Study Management (cont.)

9. Organization and Procedures Establish an organizational structure Develop procedures for every aspect of the study

10. Field Operations Data Operations Clinical Intervention PI Organizational Chart The clinical intervention should be completely separate from the research arm of the study.

11. STAFFING Field coordinator: responsible for all aspects of obtaining data  Recruiting, screening and enrolling subjects  Maintaining high response and retention rates  Assuring timeliness of data collection  Monitoring integrity of data collection Data coordinator: responsible for all aspects of processing data  Entering data  Cleaning data  Managing data  Documenting data

12. Field Coordinator is responsible for… Training (and retraining) of data collectors Supervision of data collectors Interviewers Interviewer supervisors (for larger studies) Specialty data collectors E.g., medical record abstraction E.g., measures from electronic data bases E.g., death certificate follow-up

13. Field Coordinator and Supervisors must … Have good interpersonal skills Be committed to maintaining high standards for protecting human subjects Be highly organized Be able to motivate interviewers Be vigilant about data quality

14. Personnel Issues Write detailed job descriptions  Specify roles and responsibilities for each staff member Allow sufficient time for processing through your Human Resources Department  Approval of job descriptions  Post jobs  Paperwork required E.g., Documentation of references  Union issues E.g., Maximum hours for part time and consultant personnel

15. Routine operations  Identifying, recruiting, screening and enrolling, (randomizing) subjects  Assigning ID numbers  Forms and paper flow  Coding decisions Difficult and emergency situations  Health emergency  Child abuse: reported or witnessed  Suicide risk  Threats of violence Establish Procedures for…

16. Schedule regular meetings of study team  Composition and frequency of meetings will vary at different phases of the study Examples of regular meetings prior to data collection  Instrument development  Training staff to perform study intervention Examples of regular meetings after start of data collection  Monitoring study progress: response rate, completion rate, coordination with study sites  Decision-making and problem-solving: coding, diagnosis consensus, handling unanticipated events Study Meetings

17. Study Manual To Do list  Due dates  Person(s) responsible Study proposal Study budget  Original budget  Modifications to the budget  Expenditures to date IRB application and related documents Staffing  Recruitment and hiring policies  Schedules DISTRIBUTION: PI, Co-Investigators

18. Decisions made and justification:  Study design  Sampling  Measures  Data collection  Coding  Data analysis  Etc.

19. Interviewer’s Manual General information  Description of study (excludes study hypotheses)  Role of the interviewer Ethical Considerations and Procedures  Meaning and purpose of informed consent  Method for obtaining informed consent  Maintaining confidentiality or anonymity  Special considerations for vulnerable subjects E.g., obtaining proxy consent Training  Schedule  Expectations DISTRIBUTION: All personnel EXCEPT clinical intervention

20. Interviewer’s Manual (cont.) Personnel issues  Wages and payment information  Scheduling Recruitment and enrollment procedures  Identifying, recruiting, screening and enrolling subjects Approaches for dealing with reluctant subjects  Scheduling of interviews Timing Callback procedures  Proxy interviews Assessing need Identifying and contacting proxy

21. Interviewer’s Manual (cont.) General Interviewing techniques  Asking questions  Neutral probing  Scripted prompts  Dealing with diversions, distractions and interruptions General instructions for completing study instruments  Study management forms  Data collection instruments  Time sheets  Paper flow

22. Interviewer’s Manual (cont.) Question-by-question instructions Editing instructions and protocols Miscellaneous  Assigning ID numbers  Typical problems and methods for resolving  Dress code Data collection instruments  Forms and data collection instruments  Codes inserted post-interview by interviewer or other field staff e.g., Occupation, medications, country of origin

23. Interviewer’s Manual (cont.) Checklist of materials in the interviewer’s packet  # of each instrument  # of consent forms  Response category cards  Cash for subject payments  Writing instruments  ID card  Referral information, informational brochures  Equipment Laptop computer, diskettes, accessories E.g., Tape recorder, tapes, batteries, microphone

24. Interviewer’s Manual (cont.) Method for updating  Timely documentation of additions and revisions  Informing personnel of updates

25. Study Budget Planning stage - Include costs of:  Recruiting, hiring, training, and supervising field and data operations Use spreadsheet software (e.g., Excel) for creating and managing budget  Saves time  Minimizes error Monitoring budget  Stay on target  Keep track of expenditures as they are incurred Budget statements from your institution are often months behind

26. Study Budget (cont.) Paying Interviewers: Full time, hourly pay, or by interview  Advantages and disadvantages to each E.g., Paying per interview Incentive to complete interview Easier to calculate costs in advance  Depends on study design - may need combination to ensure coverage and flexibility

27. Study Management Database Use a relational database (e.g., Microsoft Access) to manage information on:  Subjects  Non-subjects (nonparticpants & ineligibles) Create separate forms for obtaining this information  Not included in study interviews or data collection instruments

28. Study Management Database (cont.) Enter data from interviews and other data collection instruments in a separate data file  Most relational database same software, software designed for data entry, or software that will be used for statistical analysis  Variables from the study management database can be merged into the statistical analysis database as needed

29. Study Management Database (cont.) Use the study management database to generate reports on:  Progress in enrolling subjects  Reasons for nonparticipation among eligible individuals  Reasons for ineligibility  Date and location of subjects due for a follow-up interview in specified time period  Record of attempts to locate subjects for follow-up interview  Interviewer productivity

30. Study Management Database (cont.) These reports are useful for:  Increasing response and retention rates  Managing resources Scheduling interviewers Budget projections  Identifying need for retraining  Reports to funding source  Planning future studies

31. Project Management Software Useful for planning resource allocation Useful for coordinating multiple tasks and phases in a study Useful for monitoring timeliness of study activities E.g., Microsoft Project