Data Management Guidance

Data

Data refers to information that is collected, observed, processed, or otherwise gathered for analysis, or in support of such analysis, to produce original findings. This includes conditions and parameters for such collection. Research data may be recorded on any medium (e.g., electronic, paper, physical samples, etc.).

Because data can exist in many different forms, it is important to make sure that data management procedures are specific and appropriate to all types of data collected.

This document provides guidance regarding responsible data management procedures. It is important to note that different disciplines have different standards. This guidance outlines the expectations of the Eastern Michigan University Office of Research Compliance, which individual researchers should harmonize with the standards in their own discipline.

Data Use Agreements and Material Transfer Agreements

• Purpose
• Applicability
• Definitions
• Agreements
• Record Keeping

Data Management Practices

• Data collection Expand dropdown
  • Data collected should be consistent with the type of data required for planned analysis techniques and the type of data required to support or refute the proposed hypothesis/research question.
  • Data should be measured consistently and precisely. The same methodology should be used every time an experiment is conducted, and if possible, the same equipment should be used. Equipment should be calibrated the same way each time an experiment is run. Data should be recorded as precisely as possible given the equipment.
  • Data should be recorded clearly and in an unchangeable medium (e.g., pen on paper). To the extent that a changeable medium is used, changes must not be deleted, erased, or overwritten. If changes to recorded data are required, the changes should be made by crossing out the original in a way that the original data are still legible (e.g., one line through the original data). All entries, original and changes, should be initialed and dated.
  • If data collection at any point deviates from the standard operating procedure for the study, this deviation must be documented in an accessible way.
  • Data should be recorded immediately and directly, without delay, without writing on scraps of paper for later incorporation into the research record, and without having to rely on memory.
  • The principal investigator is responsible for ensuring proper training in data collection procedures for laboratory staff and research assistants.
• Data maintenance Expand dropdown
  • Original data must be maintained at all times by the EMU Principal Investigator of the study. Depending on the research procedures, copies may be maintained by other members of the research team only as necessary.
  • Data should be frequently and routinely backed up in a secure manner.
  • Data should be maintained in a format and medium that is appropriate to the data collected and the research design.
  • EMU must be able to access original data, upon request, for compliance purposes only.
• Data storage, safety and security Expand dropdown
  • Original data must be stored on the EMU campus or in an EMU account (including an EMU Google Drive account).
  • Data must be securely stored as appropriate to the type of data. For physical data, this may mean in a locked room or behind a double lock (e.g., in a locked cabinet in a locked room). For electronic data, this may mean in a password-protected file on a password-protected computer.
  • Data that involve contaminants or otherwise hazardous must be stored within appropriate safety procedures as dictated by EMU Environmental Health and Safety.
  • Data should not be left out in the open, even for a brief time.
  • Original electronic and physical data should not leave the principal investigator’s laboratory or office at EMU.
  • For human subject data, storage must be in accordance with your approved UHSRC protocol.
  • Data should be regularly backed up using similar security as used for original data.
• Data retention Expand dropdown
  • Raw data must be retained, in some form, for a minimum of five years after the closure of the study. Study closure refers to the end of the grant or the date of the final publication, whichever occurs later.
  • In certain circumstances, such as sponsor-initiated research, patent filing, filing an FDA application, or in situations where there has been an allegation of research misconduct, data must be retained longer than five years. The data retention period will be determined on a case-by-case basis with the Office of Research Compliance or the Office of Research Development and Administration, as appropriate.
  • Data must be retained on the EMU campus, on EMU computers or equipment, or on an EMU-administered cloud server (e.g., emich.edu Google Drive accounts), unless otherwise specified in a sponsor agreement and approved by the Office of Research Compliance or the Office of Research Development and Administration.
• Data access and sharing Expand dropdown
  • Access to data should be restricted to people on an as-needed basis.
  • Data may be freely and securely shared with members of the research team.
  • Data must be transferred via secure means, either by encrypting emailed data files, sharing data in a password-protected file on media (e.g., a usb drive), or by using a common password-protected account on a cloud server.
  • Whenever possible, only de-identified human subject data should be shared.
  • Data may be shared with individuals outside of EMU only upon execution of a signed Data Use Agreement (DUA). DUAs must be processed by the Office of Research Compliance in order to be considered valid.
  • Data that constitute EMU Intellectual Property may not be shared.
  • Before sharing data, consult the Office of Research Compliance in order to confirm that the data in question can be legally shared with the intended recipient.

Please contact the Office of Research Compliance with any questions or concerns about data management.

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