study management cathy s. berkman, ph.d., msw fordham university graduate school of social service
TRANSCRIPT
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STUDY MANAGEMENT
Cathy S. Berkman, Ph.D., MSWFordham University
Graduate School of Social Service
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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
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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
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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
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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
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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
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• Study management is very time consuming
• Not adequately addressed:
Often not taught in doctoral programsRelatively little written information on
“how to” Inadequate provisions in study budget
Study Management (cont.)
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• 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.)
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Organization and Procedures
• Establish an organizational structure
• Develop procedures for every aspect of the study
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Field Operations
Data Operations
Clinical Intervention
PI
Organizational Chart
The clinical intervention should be completely separate from the research arm of the study.
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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
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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
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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
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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
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• 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…
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• 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
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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
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• Decisions made and justification: Study design Sampling Measures Data collection Coding Data analysis Etc.
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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
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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
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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
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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
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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
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Interviewer’s Manual (cont.)
• Method for updating
Timely documentation of additions and revisions
Informing personnel of updates
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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
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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
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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
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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
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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
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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
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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