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Human Subject Research: Proper Record Keeping and Data Management Practices


... Sponsors (desires and FDA requirements) Federal Regulations ... Check with institutional records manager for retention policies on storage and destruction. ... – PowerPoint PPT presentation

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Title: Human Subject Research: Proper Record Keeping and Data Management Practices

Human Subject Research Proper Record Keeping
and Data Management Practices
  • Research Seminar Series
  • March 28, 2003
  • 900-1030 a.m.

  • Why is record management important?
  • What is CWRU policy on data custody?
  • How does this policy affect human subject
    research record management decisions?
  • What resources are available to assist with human
    subject research data management?

Why is Record Management Important?
  • Integrity of research
  • Intellectual property protection
  • Ensuring confidentiality
  • Compliance with sponsors requirements

Data Management and Research Integrity
  • Research data, including detailed experimental
    protocols, all primary data, and procedures of
    reduction and analysis are the essential
    components of scientific progress (NIH)
  • Integrity requires meticulous attention to the
    acquisition and maintenance of research data
  • Questions about the integrity of the research are
    often answered by inspecting and reanalyzing the
    primary data
  • If the veracity of published results are
    challenged, data can be subject to subpoena

Data Management and Intellectual Property
  • Research data are legal documents for purposes of
    establishing patent rights (NIH)
  • Legal challenges to inventorship often require
    producing the original data with recorded dates
  • Proprietary issues can also drive data access and
    sharing practices

Data Management and Confidentiality
  • Sponsors and/or the university may want data to
    be kept confidential for proprietary or security
  • Regulations to protect human subjects may require
    data to be kept confidential
  • Confidentiality concerns will dictate how data is
    collected, retained and shared

Data Management and Sponsor Requirements
  • Requirements can include
  • How long data should be kept
  • With whom data can be shared
  • Who has rights to the data

CWRU Data Custody Policy
  • Research data are defined as the material,
    originally recorded by or for the investigator,
    commonly accepted in the scientific community as
    necessary to validate research findings

CWRU Data Custody Policy
  • Principal Investigator (PI) Responsibilities
  • The PI is responsible for maintenance and
    retention of research data in accord with this
  • The PI should adopt an orderly system of data
    organization and should communicate the chosen
    system to all members of a research group and to
    the appropriate administrative personnel, where

CWRU Data Custody Policy
  • Data Sharing
  • In group research projects, the PI is obligated
    to give co-investigators access to the research
    data or copies thereof for review and/or use in
    follow-on research, with proper acknowledgement.
  • Where applicable, appropriate measures to protect
    confidential information must be taken.

Data Management Issues in Collaborative Science
  • It is important to set the ground rules early
    in collaborations with regard to
  • access to data (when, to what level, cost)
  • authorship issues
  • transfer of data, materials
  • confidentiality provisions
  • pre-existing obligations to sponsor(s)

CWRU Data Custody Policy
  • Retention
  • Research data must be archived for not less than
    three years after the final close-out or
    publication, whichever occurs last, with original
    data retained whenever possible.

CWRU Data Custody Policy
  • Data Transfer
  • When individuals involved in research projects
    who are not PIs at CWRU leave the university,
    they may take copies of research data for
    projects on which they have worked. The PI must,
    however, retain original data at CWRU.
  • If PI leaves CWRU, and a project is to be moved
    to another institution, custody of the data may
    be transferred with the approval of the Vice
    President for Research and Technology Management.

CWRU Resources for Data Management
  • Policies and Guidelines (e.g., Data Custody, IP,
    Authorship, Human Subjects)
  • Sponsored Projects Administration and Compliance
  • Andrews Records Management Agreement

Andrews Records Management
  • Can be used to store all types of paper-based
  • OSPA will cover one-time charges associated with
    sponsored project records (e.g., initial pick-up,
    delivery, shelving, destruction)
  • Department/School responsible for on-going
    storage charges ( .20 per cubic foot per month)
  • Contact Jerry Takacs at 800-260-7556 to get

Records Management for Human Subjects Research
  •        What do I have to keep?
  •        In what format do I have to keep it?
  •        How long do I have to keep it?
  •        How do I destroy records?

What is a record?
  • Any document, device or item, regardless of
    physical form or characteristic, which is created
    or received by any UHC office, department, or
    clinical area, and which serves to document the
    activities, organization, functions, policies and
    procedures, decisions or other activities of UHC
    and its staff.
  • University Hospitals of Clevelands definition
    in Administrative Policies and Procedures II

Types of Human Subjects Research Records
  • Research Records
  • Examples include but not limited to medical
    chart (research record) and information,
    questionnaires, audiotapes, photographs,
    videotapes etc.
  • IRB Records UHC policy is to retain
  • IRB Protocol files
  • IRB Minutes (including Report of Administrative
  • Policies and Procedures
  • Correspondence
  • IRB Membership Lists
  • Records of Continuing Review Activities

Human Subjects Research Records Governed By
  • Federal Regulations 21 CFR 50 (FDA) and 45 CFR
    46 (Common Rule)
  • Legal Requirements State law, federal law,
    status of organization
  • Institutional Records Retention Policies and
    schedules (e.g. Medical Records)
  • Industry Sponsors (desires and FDA

Federal Regulations Governing Research Records
  • FDA Regulations
  • 21 CFR 50 and 56  
  • INDs 21 CFR 56 312.58-68
  • Biologics 21 CFR 56 600.12
  • Devices 21 CFR 56 812.40

Federal Regulations Governing Research Records
  • OHRP/DHHS Regulations
  • 45 CFR 46 Common Rule
  • 45 CFR 46.115 (applies to IRB files)
  •              IRB Minutes
  •        Policies and Procedures
  •        Correspondence
  •        IRB Membership Lists
  •        Records of Continuing Review Activities

Federal Regulations Governing Research Records
  • Retention Period
  •   The records required by this policy shall be
    retained for at least 3 years, and records
    relating to research which is conducted shall be
    retained for at least 3 years after completion of
    the research. All records shall be accessible for
    inspection and copying by authorized
    representatives of the Department or Agency at
    reasonable times and in a reasonable manner. 45
    CRF 46.115 (applies to IRBs)

Research Records for Industry Sponsored Studies
  • Clarify in Contract with Sponsor
  •  How long records kept and in what format
  • Who pays for storage and destruction costs
  • When and how records are destroyed
  • Varies from sponsor to sponsor
  • Develop research project budgets to include
    indirect costs for record storage and/or
    destruction as necessary

Where and How to Store Research Records
  • Keep active records secured in locked cabinets.
    DO NOT store at home.
  • Keep inactive research records secure or in a
    professional records storage facility.UHC stores
    at Iron Mountain
  • Keep in paper format or on microfiche.
  • Know retention periods/agreement for research
  • Keep an accurate list of records for research
  • Storage of records in electronic formats etc.
    present special problems and issues.

Helpful Hints for Research Records
  • Know what records you have. (Keep an accurate
    updated list.)
  • Check with institutional records manager for
    retention policies on storage and destruction.
  • Keep your research records secure and
  • (For industry sponsored studies) Check with
    sponsor on record keeping requirements.
    Negotiate who pays for storage and costs.
  • Do not keep records beyond retention period
    (legal issues and costs).
  • Destroy records in a confidential manner and with
    authorization. (Keep an accurate updated list of
    records destroyed.)

Case Study
  • A post-doc suddenly tells his faculty adviser
    one day that he will be leaving at the end of the
    month (when his first year as a post-doc ends)
    for various reasons. Two days before he leaves,
    he indicates to the faculty adviser that all of
    the original survey data that he has collected
    and analyzed on the NIH supported project is in
    his desk drawer and on his computer. The faculty
    member does not verify this. A few days after
    the post doc has left, the faculty adviser checks
    the desk and computer and none of the data are
    there. The faculty member subsequently learns
    that the post-doc has prepared a manuscript for

Case Study
  • A faculty member in the Department of
    Anthropology is the PI, or Responsible
    Investigator, on the IRB protocol for her
    doctoral students ethnographic research. All
    the research is occurring in China, and the
    student Co-Investigator has collected almost all
    of the data. The IRB requests an audit of this
    research, but the faculty member tells the IRB
    that the data is in China with the student, and
    that she will only see the aggregated results
    upon her students return.

Case Study
  • A faculty member is involved in a
    multi-institutional clinical trial and as part of
    the study collects data on standard forms that
    are then scanned and stored as electronic images.
    In the interest of saving space, the faculty
    member destroys the hard-copy records. The
    sponsor subsequently requests the hardcopy
    records and is distressed to learn that only the
    scanned images remain.

Case Study
Four graduate students who share an office in
the Department of Sociology keep their survey
data (from their respective studies) in a
centralized filing cabinet in their shared
office. The filing cabinet does not lock
however, the main office door is always kept
locked. Recently, three undergraduate research
assistants have been given keys to the office in
order to perform their work duties.
Speakers Panel Members
  • Eric Cottington, Ph.D.
  • Associate Vice-President for Research
  • Nancy Erdey, Ph.D.
  • Senior Research Policy and Compliance Specialist
  • Philip Cola, M.A.
  • Director, Division of Clinical Research
  • Natale Polinko, Ph.D.
  • Assistant Director, Office of Research Compliance