Record Keeping and Data

Management in Research:
Qualitative and Quantitative

Prof. dr. Mohammad Hakimi, SpOG(K), PhD.

Learning Objectives
• Understand the importance of data safety and
management in research
• Able to identify ethical challenges in data safety
and management
Data management

• Refers to the collection, storage, processing /

analysis, dissemination and efficient use of
information.
• Data collection may take place on an ongoing
basis, at regular intervals, or as part of a one-off
evaluation.
Record-keeping

• Refers to the systematic recording of information

in standardised formats. It is sometimes also
understood to mean the storage of such
information.
Ethics and Integrity
in Data Use and Management

• In·teg·ri·ty n. 1. Strict adherence to a standard

of value or conduct. 2. Personal honesty and
independence. 3. Completeness: unity
4.Soundness

• Eth·ic n. 1. A principle of right or good conduct.

2. A system of moral values. 3. ethics (sing. In
number). The branch of philosophy dealing
with the rules of right conduct.

Source: Webster’s II New Riverside Dictionary, Based on the Webster’s II

New College Dictionary (1996)
 Data Integrity

• The assurance that data is accurate, correct and valid.

• Accuracy and consistency of stored data, indicated by an
absence of any alteration in data between two updates of
a data record. Data integrity is imposed within a database
at its design stage through the use of standard rules and
procedures, and is maintained through the use of error
checking and validation routines.
• Exact duplication of the sent data at the receiving end,
achieved through the use of error checking and correcting
protocols.
• Assurance that the data are unchanged from creation to
reception.
 Data Integrity (2)

Process to maintain data integrity depends on:

Collection (accurate representation)
Data transfer (accurate recording and transfer of
data)
Storage and Security (preventing loss of data)
Sharing of Data
Use of data (analysis)
 Data Integrity (3)
• Fabrication and Falsification of data are one of
the most serious challenges to data integrity
• Human error also contributes to loss of data
integrity
• Concern about research misconduct was a
primary motivation for a 1990 conference on data
management sponsored by the US Department
of Health and Human Services.
• Conference summarized the many ways in which
the conduct of research depends on responsible
data management.
 Data Integrity (4)

• Responsible research begins with experimental

design and protocol approval
• It involves recordkeeping in a way that ensures
accuracy and avoids bias
• It guides criteria for including and excluding data
from statistical analyses
• It entails responsibility for collection, use, and
sharing of data.
 Data Integrity (5)

• Everyone with a role in research has a

responsibility to ensure the integrity of the data.
• The ultimate responsibility belongs to the
principal investigator, but the central importance
of data to all research means that this
responsibility extends to anyone who:
• helps in planning the study
• collecting the data
• analyzing or interpreting the research findings
• publishing the results of the study
• maintaining the research records.
 Data Collection and
Integrity
• Because data collection can be repetitious,
time-consuming, and tedious there is a
temptation to underestimate its importance.
• Those responsible for collecting data must be
adequately trained and motivated
• They should employ methods that limit or
eliminate the effect of bias
• They should keep records of what was done by
whom and when
 Research Relies on Trust

• Principal Investigators are rarely supervised

• Even data collectors are rarely line-of-sight
supervised
• Research relies on a researchers to:
• Develop and employ unbiased research methods
• Honestly and accurately report a study’s methods,
data handling, and analyses
 Data Management
Includes:
• Data Collection
• Recordkeeping
• Data Analysis
• Data Ownership
• Data Storage/Retention
• Sharing Data

(Magnus & Kalichman, 2002)

Examples of Data
• Recorded by an observer
• Physical characteristics
or behaviors
• Live or
recorded
• Self-report by participant
• Questionnaires,
Checklists, Surveys
• Records of research
decisions
• Records of research
protocols
• Interaction between
participants & researcher
• Tapes/notes: Focus
Groups, Interviews
• Recordings by computer
• Digitized images
• Instrument measures
• Institutional files
• Medical or School
Records
Researchers Share
Responsibility for Data

• Principal Investigator • Data Collector

• Creates system that • Collects data
collects, records, and • Records data
stores data • Stores data while
• Trains data collectors study is in process
• Supervises data
collection, recording,
and storage
Understanding the difference between
quantitative and qualitative data
Quantitative data
This is numerical information.
• Advantages: more structured; more precise answers /
measures; perceived as more reliable; ‘objective’;
easier to analyze; based on statistically sound
methods for analysis; allows for generalizations;
collected through formalised processes and
standardised tools; strict definition of sample allows
comparability of final results.
• Disadvantages: can be hard to develop rigorous,
standardized tools; implementing solid and
sustainable data collection systems can be relatively
complex and expensive; can ‘simplify’ the reality in the
effort to provide hard, objective, numeric data (at the
expense of understanding the reality / complexity of a
situation).
Qualitative data
This is ‘narrative’ information.
• Advantages: gives an in-depth understanding of a
situation; captures differences and provides a
more holistic approach to the reality; easier to
collect; costs are relatively low; gives reasons
behind the numbers.
• Disadvantages: less structured; challenging to
analyze; ‘subjective’; perceived to be less reliable;
generalization from results is not possible; data
may not be comparable to other findings; requires
‘interpretation’.
Advantages of combining
both (e.g. qualitative and
quantitative, soft/hard data)

• Increases overall reliability and validity; increases

confidence in conclusions (richer scope and
detail); allows for complementarity and
triangulation, balancing the limitations of each
method.
 Responsible Data Collection

• It is unethical to:
• Knowingly collect data in a manner that is
biased
• Falsify or fabricate data
• Tailor or change a protocol to alter findings
• Change or remove non-conforming data to
bend findings
 Responsible Record Keeping

• Records must be thorough, complete, and

organized.

• Keep
• Outcome data
• Meeting notes and other records that show
history of work, “what was done, by whom,
and when”
(Magnus & Kalichman, 2002)
 Responsible Record Keeping
(continued)

• In quantitative studies, deviations from

protocol should be avoided
• Record all actions, incidents, and
variations from protocol in a lab notebook

(University of Minnesota, n.d.)

 Responsible Record Keeping
(continued)

• In qualitative studies, protocols may be

intentionally altered during a study
• Confirm changes with advisor &
collaborators
• Record changes, actions, incidents, and
variations in a lab notebook
• Record reasoning for above as well
 Responsible Record Keeping
(continued)

• In both qualitative and quantitative

studies, a research notebook should
• Be used only for the research study
• Have continuous pages
• Be written in ink
 Responsible Record Keeping
(continued)
• When correcting errors on data forms or
lab notebook
• Strike through, date, and initial all errors or
corrections.
• Note reasons for changes if they are not
obvious.
• Never erase.
(University of Minnesota, n.d.)
 Responsible Data Analysis

• It is unethical to change, add, or exclude data to

bias findings or produce a desired result.

• In quantitative research:
• Decisions to exclude data from analysis must be based on
objective rules, preferably established before the
‘cleaning’
• Excluded data should be described in any report made of
the study
• Reduce likelihood of biased interpretation by using blind
analysis
 Responsible Data Analysis
(continued)

• In qualitative research:
• Divergent, conflicting, or disconfirming subject themes
should be reflected in the findings
• Ensure that findings accurately reflect data through
triangulation, peer review, and member checking
 Responsible Data Analysis
(continued)

• If any qualitative or quantitative data are excluded

or changed, researchers must inform audience or
reader
• How data were reviewed
• How data were selected for exclusion or change
• Which data were excluded from analysis
• How exclusion or alteration changed findings
 Responsible Data Ownership

• Regardless of funding source, study data belong to

the institution (University or College), not the
individual researcher or collaborative group

• Institutions may choose not to exert their ownership

• Individual researchers (students and faculty) are

generally permitted to have a copy of the study data
after subject identifiers are removed
 Responsible Data Storage

• Data should be stored in a manner that protects

them from loss, theft, or damage

• Store historical records of decision making, draft

work, and other documents detailing processes
with the same care as outcome data
 Responsible Data Storage
(continued)
• Store signed consent forms separate from data
forms

• Store master-code connecting names to

participant numbers, separate from data forms

• Destroy master-code as soon as possible.

• Keep a ‘back-up copy’ of database stripped of

identifiers
 Responsible Data Retention

• Ensure that data are retrievable regardless of

technological changes in
• Devices used to collect data
• Software or hardware used to store data
 Responsible Data Retention
(continued)

• Data should be kept after study ends

• Federally funded data must be kept for at
least 3 years after a final report
(Columbia University, 2003–2004)

• American Psychological Association

recommends that data be kept for 5 years
post-publication
(American Psychological Association, 2001)
 Responsible Data Sharing

• Data sharing refers to one researcher allowing

another to use another’s raw data or database

• Federal guidelines encourage data sharing of NIH-

supported studies
(National Institutes of Health, 2003)

• Unless proprietary agreements prohibit sharing, all

interested parties may access data gathered using
public funding
 Responsible Data Sharing
(continued)

• Before sharing:
• Protect rights and privacy of participants
(e.g., IRB, HIPAA) by stripping all
identifiers or variables that could identify
individual subjects
 Responsible Data Sharing
(continued)

• Data cannot be shared if:

• It is impossible to strip identifiers or
otherwise protect confidentiality and
anonymity of subjects.
• Sharing compromises proprietary
information and there are temporary
restrictions specified by contractual
agreement with sponsors