STUDY MANAGEMENT

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

• Worthwhile research question
• Clearly defined study aims
• Well-designed methods

• Properly conducted study
• Focus of this lecture

• 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 projects 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 (cont.)

• 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

8
Study Management (cont.)

• 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

9
Organization and Procedures

• Establish an organizational structure
• Develop procedures for every aspect of the study

10
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
Establish Procedures for

• 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

16
Study Meetings

• 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

17
Study Manual
DISTRIBUTION PI, Co-Investigators

• 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

18

• Decisions made and justification
• Study design
• Sampling
• Measures
• Data collection
• Coding
• Data analysis
• Etc.

19
Interviewers Manual
DISTRIBUTION All personnel EXCEPT clinical
intervention

• 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

20
Interviewers 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
Interviewers 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
Interviewers 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
Interviewers Manual (cont.)

• Checklist of materials in the interviewers
  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
Interviewers 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