STUDY MANAGEMENT

Cathy S. Berkman, Ph.D., MSWFordham University

Graduate School of Social Service

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

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

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

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

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

• 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.)

• 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.)

Organization and Procedures

• Establish an organizational structure

• Develop procedures for every aspect of the study

Field Operations

Data Operations

Clinical Intervention

PI

Organizational Chart

The clinical intervention should be completely separate from the research arm of the study.

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

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

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

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

• 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…

• 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

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

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

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

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

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

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

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

Interviewer’s Manual (cont.)

• Method for updating

Timely documentation of additions and revisions

Informing personnel of updates

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

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

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

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

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

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

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