What is Human Subjects Research?

According to Department of Human & Health Services (DHHS) definitions of research and human subjects.  Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

  • Data through intervention or interaction with the individual, or
  • Identifiable private information.

DHHS provides Human Subject Regulations Decision Charts to assist investigators in deciding the following:

  • whether an activity is research that must be reviewed by an IRB
  • whether the review may be performed by expedited procedures, and 
  • whether informed consent or its documentation may be waived.  

The Research Cycle:


  • Requires knowledge management continuity that encompasses the whole system.

Research Stakeholders:


  • Stakeholders touch the research cycle at various stages and have a diverse set of needs during throughout their role in the research project.

  • Identification of stakeholders allows roles and responsibilities for the study to be assigned at any step of the process. 

  • Goal is to create a seamless transition between roles throughout the research cycle. 

REDCap's role:

  • REDCap’s users have developed a variety of task specific tools to assist in various stages of the research cycle.
  • By considering the research study as a whole, REDCap has the potential of bridging the gap in system knowledge that plagues our research institutions.
  • A publicly available comprehensive systematic approach to research studies inspires confidence in researchers and clinical research coordinators, standardizes an approach to study management, and provides tools to manage researcher need in  study management documentation. 

  • Cincinnati’s CCTST REDCap purposes the REDCap Human Subject Toolbox as a tool to improve, standardize, and save time across an institution's study management workflow. 
  • The Human Subject Tool box is an effort to encourage research teams to consider a more systematic approach and to consider the full scope of research projects when planning data capture and study management systems.

How can the Human Study Toolbox help me?

REDCap is adaptable to many research scenarios.  This toolbox provides helpful hints and guidance on different or unique aspects of collecting and storing information related to human subject research.  Topic areas are listed below. If you have an idea for a topic for the Toolbox, we would be delighted to hear from you. Comment below to send us your ideas. 

REDCap tools by Research Cycle:

  1. Assemble the Research Team
    1. Study Personnel Log: Record and track study personnel credentials.
  2. Preparation of Study File
    1. Stages of collecting data from participants using a survey.
      • Designing REDCap database for data collection from participant using the survey function.
      • Designing REDCap database for data collection study staff using the data entry form.
    2. Develop Regulatory Database(s)
      • Regulatory binder: Organize essential study specific documentation to facilitate knowledge transition of study activities & information.

      • IRB Protocol Review & Approval: Facilitate the study protocol’s interaction with IRB.

      • Delegation of Authority Log: Document study personnel’s roles and responsibilities throughout the life of the study. 
  3. Train the Team Members

    1. Training Documentation Log: Tracking log to provide a comprehensive list of all training completed by study staff.

  4. Recruit Participants
    1. Develop Participant Database(s)
      • Participant Contact & Schedule Log: Document potential participant contact & facilitate pre-visit tasks.

      • Screening Log: Mechanism for determining eligibility of potential participants and facilitate the recruit-to-enroll process.

  5. Study Specific Tasks

    1. Study Enrollment: Track participants enrollment status. (Current, Finished, Withdrawn)

    2. Consent: Document informed consent electronically.

    3. Study Specific Data: Collect and store study's data for 
    4. Biospecimen Log: Tracking sample management.
    5. Pharmacy Log: 
    6. Benefit Management Log: Facilitate the distribution and recording of study benefits.
  6. Moinitor Study Progress
    1. Monitoring Log: Record all monitoring visits to provide a comprehensive list of oversite actions.
    2. Grant Management Log: Record study’s grant progress.
  7. Study Completion and Termination
    1. Study Closure Log: Track institution’s studies log and their current status (Pre-approval, In-progress, Closing, Closed)
    2. Steps for processing data prior to data analysis.

Templates created by CCTST REDCap are intended to be tailored to each study project, team, and/or department.

Link to Demonstrations

REDCapCon 2018 Presentation 

"Bridging the Communication Gap with the Holistic REDCap Human Subject Toolbox for Research Institutions"

Theresa Baker, MS; Maxx Somers, MA; Warren Welch; Michael Wagner, PhD

Cincinnati Children’s Hospital Medical Center

Theresa Baker REDCap Toolbox Poster.pdf


Developed by Theresa Baker

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