DHHS/NIH/OD/OIR/OHSRP

1/2/2015
 The audience for this course is Principal Investigators (PIs), investigators
and Research Coordinators (RCs) serving on the study team of human
clinical studies and trials.
 This course consists of 4 modules and a knowledge quiz.
 You must complete the entire course and successfully pass the quiz to
obtain credit for this course at the NIH.
 On average this course takes 30 minutes to complete.
 Once you have passed the course, download and retain your completion
certificate, and provide a copy to your Principal Investigator (PI) and/or
Institutional Review Board (IRB) as requested
 Your completion record consisting of your Name, IC, and successful
completion date will be retained in the OHSRP HRPP Training database:
https://federation.nih.gov/ohsr/nih/investigator-training.php
 Records in this database can be viewed by the NIH community and are
secured behind the NIH firewall. You have a right not to have your
records included in the database, but you will be responsible for
providing them upon request to your PI or IRB.
Purpose: This course provides an overview of data quality
management practices that support valid findings from
research studies.
 Module 1- Why have Data Quality Management in
Clinical Research?
 Module 2 – Good Clinical Practice (GCP) Requirements
and Elements of a Data Management Plan
 Module 3 – The Research File and Regulatory Binder
 Module 4 – QC/QA, Good Laboratory Practice (GLP),
Monitoring and Audits
 Module 5- Bringing it All Together, Planning for
Success
 Quiz
Investigators and institutions invest extensive resources, time and effort to conduct research
likely to result in important information to improve human health or conditions. Subjects
donate time and their materials to answer the questions researchers ask. Conducting research
involves a myriad of details and day to day, it can be easy to lose sight of the data quality in all
of this effort.

All research results in data to be analyzed which supports or refutes the study hypothesis. Poor
data results in a waste of effort and resources and puts subjects and ultimately patients at risk
of harm. It is for this reason that institutions, sponsors, and regulators invest such effort to
ensure that research data is of high quality and validity.

 Good Clinical Practice (GCP) and Good Laboratory Practice Guidelines (GLP) are among the
most widely recognized standards for conducting well-run trials and for managing research
data and records. These standards are used by institutions, sponsors and regulatory
agencies, such as the FDA, to monitor the conduct of research and data collected on trials.

What you need to know:

This course is based on FDA E6 GCP Guidelines. However, regardless of the type of research
conducted, these guidelines are the basis of effective Data Quality Management (DQM).
Institutions, Sponsors and Regulators use Auditing and Monitoring to ensure quality and
validity of research results. While there are many forms of monitoring (including auditing) the
primary focus tends to be on data collection and management. Below we describe the forms of
monitoring you may experience as you conduct research, including:

◦ Safety Monitoring – Monitoring by a Safety Monitoring Committee, a Data and Safety

Monitoring Board (DSMB), a Medical Monitor or other similar entity are all forms of safety
monitoring. This is a highly formalized process and often includes outside experts who
are not part of the study team. The level and frequency of monitoring is related to the
level of risk inherent in the research and the power of the study. These committees
generally review safety data and when applicable, blinded data collected on a
randomized trial or data from multicenter research.

◦ Sponsor Monitoring – Sponsors monitor the study records and processes to ensure a well
run trial is being conducted and that the data being provided is of high quality and
validity. If the data is not valid, the Sponsor cannot use the data to support a marketing
application before the FDA. Expect Sponsor monitors to inspect your regulatory binders
(including informed consents and eligibility criteria) and study data (including source
documents and CRFs)

◦ IC Quality Assurance and Monitoring – The NIH is entrusted with public funds to conduct
research that will enhance human health and conditions. As result of this trust, the NIH
establishes quality assurance (QA) plans and conducts random and for–cause audits of
the research conducted by its investigators. Additionally, ICs conduct monitoring based
on level of risk (risk-based) or if asked by an IRB or IC leadership (for-cause).
Some other forms of monitoring/auditing include:

◦ Internal monitoring: Study teams also have a responsibility to self-monitor study

processes and data, also known as quality control (QC). This self-monitoring can ensure
a well-run trial and to identify and mitigate issues before they are identified by
monitoring entities; which can result in time-consuming fixes. Internal monitoring
includes monitoring for proper informed consent documentation/records, eligibility
criteria, data quality, etc…

◦ Audits by Regulatory Authorities– Regulatory agencies such as the Food and Drug
Administration (FDA) or the Office for Human Research Protections (OHRP) conduct both
random and for-cause audits of protocols under their regulatory authority. Serious
issues revealed by a regulatory authority can have serious consequences including
stopping the study or in a worse-case scenario, debarment of an investigator.

What you need to know: While you may experience any of the types of monitoring listed
above, this course focuses on internal monitoring that the study team performs to ensure
the validity and integrity of the study data.
Monitoring is usually conducted by interested parties involved in the research
(investigators, institutions, sponsors) to identify issues and to improve processes. The goal
is quality control and quality improvement (QC/QI) and it is usually conducted on a
predetermined cycle unless it is for-cause. Monitoring often identifies deficiencies that
require a corrective and preventative action (sometimes referred to as a CAPA) plan.

Auditing is usually conducted by regulatory agencies to confirm that requirements are

being met. This type of monitoring is much less frequent and is based on regulatory
requirements or concerns. Auditing can be random or for-cause. Auditing can result in a
corrective action plan but it can also result in punitive action such as stopping research or
in a worse-case scenario, debarment of the PI.

What you need to know: The NIH Human Research Protection Program (HRPP) and ICs
establish annual QAQI plans which are implemented throughout each year. The focus may
change from year to year. It is likely that you will experience monitoring by your IC at one
point or another.

If you are conducting sponsored research, you will be monitored by your Sponsor, based on
your monitoring agreement.

Auditing by the FDA would only occur if you are conducting FDA-regulated research. This
type of auditing normally takes place at the end of Phase II or before submission of a
marketing application. If the FDA becomes aware of issues on a trial, they could conduct a
for-cause audit at any time.
Risk-based monitoring: If the risks of the study interventions are more than minimal then
the IC may always monitor your study, or it may put your study in a pool of more than
minimal risk studies to be randomly monitored.

Random monitoring: Because monitoring and auditing is a labor and resource intensive, it
is not feasible for institutions or regulatory agencies to monitor every study. Studies may
be selected randomly for monitoring or audit not because a particular issue or concern has
been identified.

For-cause auditing: If a sponsor, institution, IRB or regulatory agency identifies a concern

about the conduct of a study or qualification of investigators, the entity will conduct a for-
cause audit or monitoring visit. Continued monitoring may occur to assess if the CAPA plan
was effective.

What you need to know: It is important to understand some of the terminology and types of
audits a research study team could experience.

While you may experience any of the types of monitoring listed above, this course focuses
on data quality management that study teams can perform to ensure a well-run protocol
that will result in important information to further human health.

The next section provides some more definitions about data quality management.
 Case Report Form (CRF): A CRF is a structured document for the collection of study data
extracted from the source documentation. The CRF may be a paper or electronic form
maintained in a clinical trial management system (CTMS) or remote data management system
(RDMS).

 Data Monitoring Plan (DMP): The DMP describes the following: data to be collected; how and
where the data are captured and stored; process for reporting and handling corrections;
confidentiality and data sharing; common terminology and roles and responsibilities. The DMP
should be included in the protocol but may be elucidated in a Standard Operating Procedure
(SOP). Often the safety plan is combined with the DMP and is referred to as a Data and Safety
Monitoring Plan (DSMP).

 Data Quality Management (DQM): A formal quality improvement process that ensures the
validity and integrity of data during collection, aggregation, storage and analysis.

 Quality Assurance (QA): For the purposes of this course, QA a is planned and systematic activity
implemented as part of a quality system to ensure that quality requirements (validity) of the
data generated during the research will be fulfilled.

 Quality Control (QC): For the purposes of this course, QC is a real-time review (monitoring) of
data to verify the accuracy and validity by study staff involved in the research.

 Quality Improvement (QI): A systematic process including the analysis and correction of
gaps/issues for the improvement of a process such as data management.

 Source Data: Raw, unprocessed data collected from the subject throughout the course of the
study including screening, H&P, laboratory, safety, procedural and survey data. These data may
be held in a variety of systems and records including the medical record.
 Data quality management (DQM) is a formal process for managing the quality,
validity and integrity of the research data captured throughout the study from
the time it is collected, stored and transformed (processed) through analysis
and publication. This is achieved via two processes referred to as Quality
Assurance (QA) and Quality Control (QC) (Module 4).
 DQM starts with a data management plan (DMP) that is specified in the protocol,
as a component of the data safety monitoring plan (DSMP) and approved by the
IRB and sponsor, as applicable, before the protocol starts. (Module 2)
 DQM includes the organization and retention of key study documentation,
known collectively as the Regulatory File (or binder). The Regulatory File is
organized and retained to support monitoring and auditing by ICs, IRBs, the
HRPP, Sponsors or Contract Research Organizations (CROs) and regulatory
authorities. The regulatory file is maintained by the study staff. (Module 3)

What you need to know:

 Every protocol should include a Data and Safety Monitoring Plan (DSMP)
 The DQM plan is part of the DSMP and continues throughout the conduct of the
study
 For more information about Data and Safety Monitoring, see SOP 17 - Data and
Safety Monitoring
 All research results in the production of data that must be processed and
analyzed to support or refute the study hypothesis
 The data must be of sufficient quality and integrity to support the endpoint
analyses
 The data used to support marketing applications for FDA-regulated research
must be accurate and validated
 FDA E6 Good Clinical Practice (GCP) standards will be used as the basis of this
course
What you need to know:
 The NIH HRPP promotes rigorous data quality management that supports the
findings of NIH research studies which have important implications for the health
of the public, regardless of whether the studies are FDA-regulated or not
 Quality data management is the structure that supports high-quality outcomes
for clinical research
 Following best practices for data management is a continuous process that
utilizes quality control (QC)/quality improvement (QI) methodology
Below is a list of regulations, policy and guidance regarding data quality management:
FDA GCP Guidelines: Below are a selected list of sections from the FDA E6 Guidelines that may
be of interest:
 Investigator Responsibilities (4.9-4.13)
 Sponsor Responsibilities (5.1, 5.5, 5.10, 5.11, 5.15, 5.18, 5.19 and 5.22)
 Essential Documents for the Conduct of a Clinical Trial (Section 8)
NIH Policy:
 SOP 15 - Research Regulated by the Food and Drug Administration (FDA): General
Procedures for Both IND and IDE Applications
 SOP 17 - Data and Safety Monitoring
 SOP 19 - Investigator Responsibilities
Regulatory Requirements for Record Keeping for FDA-regulated Research:
 21 CFR Part 312.62 Investigator recordkeeping and record retention
 21 CFR Part 812.140 Records
 21 CFR Part 11: Electronic records submitted to the FDA

What you need to know:

 Investigators must abide by FDA regulation and NIH policy as applicable
 It is strongly recommended that all investigators follow GCP guidance for data
management whether conducting FDA-regulated research or not.
A Data Monitoring Plan (DMP) includes:
 Specification of the data to be collected on the protocol
 Case Report Forms (CRFs) to be developed
 Establishment of desired best practices (QA) for:
◦ Collecting source documentation (raw data)
◦ Extracting research data from the source data to complete the Case Report
Forms (CRFs)/data management system
◦ Maintaining confidentiality of data
◦ Plans for secure storage of data with limited data access
 Processes for Quality control (QC) of data and the specification of processes
for corrections of incorrect data
 How data will be transformed (processed) to prepare it for analysis
 Quality assurance processes and timing for raw and transformed data

What you need to know:

 Data management best practice starts with the data monitoring plan (DMP) and
CRF/data system structure
  Quality Assurance (QA): For the purposes of this course, QA a is planned and
systematic activity implemented as part of a quality system to ensure that
quality requirements (quality and validity) of the data generated during the
research will be fulfilled.
 QA procedures should be specified in the DMP

 QA plans should establish processes or systems that prevent errors. Methods

include double data entry, audit trails and real-time field-level validation.

 QA processes should not adversely impact the power or blinding.

What you need to know:

 QA is the activity that supports the generation of quality, validated data from the
research.
 Inform your PI as soon as possible if QA procedures are not preventing errors.
 Consult your biostatistician or epidemiologist for guidance as needed.
Quality Control (QC): For the purposes of this course, QC is a real-time review of
data to verify the accuracy and validity by study staff involved in the research.
 Quality control (QC): of data collected in source documents and CRFs
 Timeliness: QC should happen in real-time, close enough to the data collection to
ensure the validity of the data if clinical (such as laboratory results) ; or as soon as
feasible for complex or batched data (such as genomic or deep sequencing data)
 Validation: should happen in real-time and not after the study has ended and
should be consistent with established QA processes.
 Manual Corrections: should never obscure the original data. Use strike through
and write your initials for paper and audit trails for systems.
 QC of raw and transformed data should be consistent with the DMP and should
not adversely impact the power or blinding. Consult your biostatistician or
epidemiologist for guidance.

What you need to know:

 QC is a continuous practice that should happen in real-time, close enough to the data
collection to ensure the integrity and validity of the data.
 QI requires that errors should be corrected as soon as possible following
identification. Unexpected errors requiring new corrective procedures should be
addressed with your PI as soon as possible.
Data quality management involves the entire research team:
 The Principal Investigator is ultimately accountable for the quality and
integrity of the data and for establishing and managing the data monitoring
plan and the regulatory and research files
 Investigators are responsible for collecting and recording the data consistent
with the data monitoring plan
 Research staff are responsible for implementing the data monitoring plan
including quality control of data as it is collected and recorded and for
maintaining the Regulatory Files
 Sponsors are responsible for monitoring data, as applicable
 Institute/Centers (ICs) are responsible for monitoring the data consistent
with their QA plans
 NIH IRBs may request that the IC audit a study to investigate problems that
have been brought before the Board
 Regulatory bodies such as the FDA/BIMO are responsible for auditing data in
support of marketing applications or “for cause” audits
What you need to know:
 The entire research team is responsible for data quality management in one
capacity or another.
GCP Standards (FDA E6):
 provide a universal framework for data quality management that applies to
all types of biomedical or social behavioral research.
 identify responsibilities for investigators and sponsors for data management:
 Investigator Responsibilities (Sections 4.9-4.13)
 Sponsor Responsibilities (Sections 5.1, 5.5, 5.10, 5.11, 5.15, 5.18, 5.19 and
5.22)
 Records management: (Sections 2.10, 4.9, 5.1, 5.21, 5.22)
 Confidentiality (Sections 2.11, 5.5.3(d))
 Quality control (Sections 2.13, 4.9.1; 4.9.3; 5.1.3)
 Monitoring/Auditing (Sections 1.25, 2.13, 4.1.4, 5.5)
 Management and contents of the Regulatory File (Sections 4.9.4, Section 8)

What you need to know:

 Even if you do not conduct FDA-regulated research, the standards above
establish best practices for data management.
GCP Standards require that all clinical trial information should be recorded, handled, and
stored in a way that supports accurate reporting, interpretation, and verification (Section
2.10).

Investigator responsibilities for data management are outlined in Section 4.9:

 Records management: The PI should ensure the accuracy, completeness, legibility, and
timeliness of the data recorded in the Case Report Forms (CRFs) and any applicable
reports.
 Data extraction: Research data captured on the CRF, which are extracted from source
documents, should be consistent with the source documents or the discrepancies
should be explained.
 Quality Assurance and Corrections:
◦ QA systems with procedures that assure the quality of every aspect of the trial should
be implemented (Section 2.13).
◦ Any change or correction to a CRF should be dated, initialed, and explained (if
necessary) and should not obscure the original entry (i.e., an audit trail should be
maintained); this applies to both written and electronic changes or corrections. The
investigator should retain records of the changes and corrections. Check with your
Sponsor about requirements, if applicable.

What you need to know:

 If you are a PI, you are responsible for ensuring that your investigators and research
staff comply all the applicable data management standards.
Investigator Responsibilities continued:

Confidentiality :
 Confidentiality of records that could identify subjects should be protected, respecting
the privacy and confidentiality rules in accordance with the applicable regulatory
requirement(s) (section 2.11).
 Maintain security systems that prevent unauthorized access to the data (section
5.5.3(d).

Monitoring:
 The investigator/institution should cooperate with monitoring and auditing by the
sponsor, and inspection by the appropriate regulatory authority(ies) (section 4.1.4).

What you need to know:

 As an investigator, you are accountable for the quality and integrity of the data.
 You are responsible for complying with monitoring and auditing of the data.
 For more information see SOP 17 - Data and Safety Monitoring and SOP 19 -
Investigator Responsibilities.
In FDA-regulated research, the Sponsor is responsible for:
 Quality Assurance (QA) and Quality Control (QC)by securing direct access to
source data/documents via a written agreement with the investigator
(Section 5.1)
 Trial management, data handling, recordkeeping and establishing an
Independent Monitoring Committee (Section 5.5).
 Obtaining proof of IRB review from investigators (Section 5.11)
 Record Access (Section 5.15)
 Monitoring and 5.19 Auditing (Sections 5.18 and 5.19)
 Clinical Trial/Study Reports (Section 5.22)

What you need to know:

 If you are a Sponsor-Investigator on an FDA-regulated trial, you are
responsible for complying with the applicable standards for Investigators in
Section 4 and Sponsor requirements in Section 5 of the GCP standards.
 Here at the NIH the ICs are generally responsible for convening Data Safety
Monitoring Boards (DSMBs), work with your CD if you think you need to
convene a DSMB.
The regulatory binder may be a physical binder (or set of binders) or an electronic directory
containing all the essential documents, which, when taken together, support the validity,
quality and integrity of the data produced in the trial and demonstrate compliance by the
investigators with regulatory requirements as applicable.

GCP provides a comprehensive list of essential documents that should be retained in the
regulatory binder at each phase of the study:
 Before the study commences
 During the conduct of the trial
 After completion/termination of the trial
Note that the records in the regulatory binders may contain the research
subject codes instead of subject identifiers. (It is possible that external
sponsors may not wish to view individually identifiable information)
What you need to know:
 Regulatory binders may be audited by the sponsor or other regulatory
authorities as applicable.
 Regulatory binders may be inspected during post-approval monitoring by
the IC and/or the Sponsor
The research files contain copies of the signed informed consents and
source documentation (e.g. medical records from treating physicians,
outside lab results or surveys).

The consent template in use at the NIH Clinical Center (CC) informs
subjects of the possibility that their private information might be seen
by others outside the research team including regulatory agencies. If
your research is not conducted at the CC, and there is a possibility that
the protocol will be monitored (such as with FDA-regulated research)
the consent document should inform subjects of this possibility.

What you need to know:

 At the NIH Clinical Center (CC), the original signed consents
obtained at the CC are provided to Medical Records Department.
 Research files should also be provided to monitoring entities upon
request.
Examples of documents generated before the study commences:

 IRB-approved Protocol, including initial and amended versions

 IRB-approved Informed Consent(s) and other subject information
 IRB-approved recruitment materials
 IRB approval documentation and other institutional approvals
 Regulatory notifications and correspondence
 CVs and documentation of qualifications of investigators and training records
 CRFs and lists of normal values, ranges of procedures or tests (such as lab tests)
 Standard Operating Procedures for: data, specimens, shipping/handling,
investigational agents, randomization, blinding/unblinding, safety procedures,
etc…
 Trial agreements, as applicable
 Investigator brochure/other prior experience w/the device, as applicable
 Monitoring plan and trial initiation monitoring report, as applicable
Examples of documents generated while the study is ongoing:

 Revisions to any of the documentation listed previously

 Monitoring visit reports
 Signed/dated informed consents (may be maintained in the research record)
 Source documents
 CRFs (signed and dated) and documentation of corrections
 Reports to Sponsors such as AE and SAE reports
 Reports to IRBs such as unanticipated problems, protocol deviations or other
safety information
 Continuing reviews and other interim reports to the IRBs
 Subject logs, such as screening, enrollment, and communications such as
related to subjects lost to follow-up, etc…
 Drug accountability and handling logs
 Specimen and data tracking logs
Examples of documents generated after the study closes:

 Final reports to the IRB and regulatory authorities as applicable

 Final Monitoring visit and Audit reports as applicable

 Clinical study report

 Final subject identification lists and treatment allocation/decoding, as

applicable

 Final drug accountability and product destruction logs, as applicable

 Final specimen and data tracking logs

What you need to know:

 The content of regulatory binders may vary somewhat depending on the

nature of the study, but FDA-regulated studies must have complete
information included in these files in the event of an audit or inspection. See
GCP Section 8 for a complete list of documents.
Quality Assurance (QA): For the purposes of this course, QA a is planned and
systematic activity implemented as part of a quality system to ensure that quality
requirements (quality and validity) of the data generated during the research will be
fulfilled.

 The research team should establish a data quality management plan and a quality
control cycle before the research starts.

 Case Report Forms/tools should be clearly defined based on the data needed to
validate the primary and secondary endpoints

 Manual Data should be captured as soon as feasible after collection to ensure

accuracy and validation

 Data systems should be consistent with Case Report Forms/tools and data
validation should be defined where ever possible to avoid spurious data and to
promote timely data validation. For example if you are collecting HbA1c’s in a data
field, make sure that the field captures only numerical values. When feasible set
expected ranges and force validation by the user if the data entered is out side the
expected range. Ensure the data system has an audit trail or place to capture notes.

What you need to know: A well-organized and precise set of data collection tools
promotes greater data accuracy and supports the interpretation of results

You can also work with your IC QA Contact to develop a plan or strategies, if you don’t
know who your contact is speak with your Clinical Director.
Quality Control (QC): QC is a real-time review of data to verify the accuracy and
validity by study staff involved in the research.

 QC activities should take place on a pre-determined cycle that will not

jeopardize the data analysis, therefore a QA plan should be established before
the protocol starts, paying particular attention to the QC cycle including who
and how frequently the data will be monitored.

 What you need to know: Quality Control should occur on a regular basis to
ensure accuracy and completeness of study data. As soon as feasible, clarify,
validate, and correct any unclear or out-of-range data.

Internal monitoring should never unblind data. Consult your epidemiologist or

biostatistician if you have questions or concerns.
You just found out your data will be monitored by your sponsor, IC or regulatory body,
what is your responsibility?

 To cooperate with the monitors/auditors

 Be prepared to provide your: regulatory binders, read-only access to your database

or systems, including redacting and copying some records

 To notify your IC CD and OHSRP if you are going to be audited by OHRP or the FDA

 Provide a quiet space for your monitors/auditors to work and read-only access to
systems

 Be available to monitors/auditors to answer questions and provide clarifications

 Be prepared to explain your operational processes for capturing, entering and

validating your data including your QC/QA and QI processes.

 Establish and implement a corrective action plan to address deficiencies identified

by monitors/auditors.

 To respond promptly to any monitoring reports that identify deficiencies or issues

 To report any issues to the IRB and how they were resolved.
What should you expect during a monitoring visit?

 You will be provided a list of records or binders to pull in preparation for and
during the visit

 Expect monitoring to take place over several days and up to a week

 You may have very little notice of a visit; you may need to reschedule subjects

 You may have end-of-day and/or end-of-monitoring debriefings, the PI should be

present.

 Expect the monitor/auditor to focus very closely on the completeness of your

regulatory files. In particular, the signed informed consents, compliance with
eligibility criteria and how complete and current your data are.

 A report of the results from the monitoring, including a list of items to be corrected
or addressed ; including how soon you must respond (Note that this is called a
“483” when issued by the FDA)

 If a corrective action plan is put in place that is acceptable to the monitors/auditor

you may have continued monitoring to see if the plan worked.
 Poor data results in a waste of effort and resources and puts subjects as risk of
harm. If feasible work with your data manager. Keep the following best practices
in mind to ensure that your research efforts result in high-quality, validated data:
 Plan for quality data collection
 Design case report forms/tools to capture the data needed to support the
primary and secondary endpoints
 Design the data management system to be consistent with the case report
forms/tools and:
 For standard clinical, eligibility and safety data, set in validation where
ever possible
 Consider double entry for key data variables and when manually entered
 Use an audit trail- an audit trail runs behind the user interface and tracks
all additions, removals and changes and track who made them and when
 Allow users to capture notes about data that are out of range
 Strive for timely data entry and real-time data validation
 Establish a plan for validating batched data or complex data sets that are
not manually entered.
Even if your protocol has a Data Safety Monitoring Committee or Board you should
still internally monitor (QC) your data frequently for completeness and accuracy.

 PI - Establish who and how frequently data will be managed.

 QA team member- establish strategies to avoid further errors in the future

promptly, test and retest until you are sure you have addressed the problem
◦ Promptly notify your PI and consult your statistician/epidemiologist if you
identify major concerns.
◦ Be careful during QC, never monitor data in such a way to unblind or otherwise
jeopardize the power or data analysis, consult your statistician and PI.

 Entire research team - If issues are identified notify the PI and resolve them
promptly.

What you need to know: You may not responsible for all the tasks above, but you are
still responsible for understanding your role and for the quality and integrity of the
data you collect, record or manage.

 Use resources available to you: consult your IC QA contact, PI, statistician or data
managers for tips and best practices.
1. What type of monitoring can a study team perform to identify possible issues with data quality
or integrity?

____ a. For-cause auditing

____ b. Internal monitoring
____ c. Random monitoring

2. Some elements of Data Quality Management (DQM) include establishing a Data Monitoring
Plan (DMP) in the protocol and maintaining the regulatory file. ____ True ____ False

3. Some elements of a DMP include:

____ a. A corrective and preventative action (CAPA) plan

____ b. Definition of source documentation and Case Report Forms (CRFs)
____ c. Plan for QC/QI of raw and transformed data
____ d. a and b
____ e. b and c
4. Research staff is responsible for establishing and maintaining the regulatory files.

____ True ____ False

5. Should copies of the signed informed consents be retained in the research file or
regulatory binder? __Yes __No

6. Regulatory files are not only for use by the research team, they may be inspected by
monitoring entities. ____ True ____ False

7. Quality Control (QC) of study data should occur:

____ a. on a random basis by an auditor

____ b. on a regular basis by the study team
____ c. on a pre-determined basis by the IC QA monitor
8. The PI should promptly notify the IRB if protocol deviations are uncovered by the
monitoring of the study and what the corrective action plan is. ____ True ____ False

9. Good Clinical Practice Guidelines covers:

____ a. quality and integrity of study data and results

____ b. contents of the regulatory files
____ c. Rights, safety and welfare of research participants
____ d. all of the above
____ e. a and c

10. The entire research team has a role to play in Data Quality Management.

____ True ____ False

 Data Quality Management Quiz Key

1. What type of monitoring can a study team perform to identify possible issues with
data quality or integrity?

____ a. For-cause auditing System: Incorrect. Internal monitoring by the

study team is the correct answer.

____ b. Internal monitoring System: Yes, that is correct!

____ c. Random monitoring System: (Use response to item a.)

2. Some elements of Data Quality Management (DQM) include establishing a Data

Monitoring Plan (DMP) in the protocol and maintaining the regulatory file.

____ True System: Yes, that is correct!

____ False System: Incorrect, establishing a Data Monitoring Plan (DMP) is an

important component of Data Quality Management.

3. Some elements of a DMP include:

____ a. A corrective and preventative action (CAPA) plan System: Incorrect:

Defining the source documentation and the case report forms (CRFs) and
planning for QC/QI of raw and transformed data are elements of a DMP.

____ b. Definition of source documentation and Case Report Forms (CRFs)

System: Partially correct, this element and the Plan for QC/QI of raw and
transformed data are both elements of a DMP.

____ c. Plan for QC/QI of raw and transformed data System: Partially correct,
this element and the definition of source documentation and CRFs are both
elements of a DMP.

____ d. a and b System: (Use response to item a.)

____ e. b and c System: That is correct!

4. Research staff is responsible for establishing and maintaining the regulatory files.

____ True System: That is correct!

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 Data Quality Management Quiz Key

____ False System: That is incorrect. Investigators and/or research staff are
responsible for establishing and maintaining the regulatory files.

5. Should copies of the signed informed consents to be retained in the research

files or regulatory binder?

__Yes System: That is correct!

__No System: That is incorrect. Copies of the signed informed consents are
maintained as part of the research files or regulatory binder. At the NIH Clinical
Center (CC), the original signed consents obtained at the CC are provided to
Medical Records Department.

6. Regulatory files are not only for use by the research team, they may be inspected
by monitoring entities.

____ True System: That is correct!

____ False System: That is incorrect. The regulatory files must be made
available for inspection by monitoring entities, (e.g. IC or Sponsor monitors, or
FDA inspectors/auditors.

7. Quality Control (QC) of study data should occur:

____ a. on a random basis by an auditor System: That is incorrect. QC is the

responsibility of the study team and should take place on a regular basis.

____ b. on a regular basis by the study team System: That is correct!

____ c. on a pre-determined basis by the IC QA monitor System: That is

incorrect. QC is the responsibility of the study team and should take place
on a regular basis.

8. The PI should promptly notify the IRB if protocol deviations are uncovered by the
monitoring of the study and what the corrective action plan is.

____ True System: That is correct!

____ False System: That is incorrect. PI’s are required to report protocol
deviations to the IRB, regardless of how they are identified, per HRPP SOP 16 -

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 Data Quality Management Quiz Key

Reporting Requirements for Unanticipated Problems, Adverse Events and

Protocol Deviations.

9. Good Clinical Practice Guidelines covers:

____ a. quality and integrity of study data and results System: That is partially
correct. GCP also covers: contents of the regulatory file, and rights, safety and
welfare of research subjects as well as other topics.

____ b. contents of the regulatory files System: That is partially correct. GCP
also covers: quality and integrity of study data/results and, rights and safety and
welfare of research subjects, as well as other topics.

____ c. Rights, safety and welfare of research participants System: That is

partially correct. GCP also covers: quality and integrity of study data/results and
contents of the regulatory file, as well as other topics.

____ d. all of the above System: That is correct!

____ e. a and c System: System: That is incorrect. GCP covers all of the
following: quality and integrity of study data/results, contents of the regulatory file,
and rights, safety and welfare of research subjects, as well as other topics.

10. The entire research team has a role to play in Data Quality Management.

____ True System: That is correct!

____ False System: That is incorrect, the entire research team as a role to play.

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