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 1 2024 CCDA Exam Study Guide

CCDA EXAM STUDY GUIDE

This document is a study guide to help test takers prepare for the CCDA
Exam by listing the chapters in the Good Clinical Data Management
Practices (GCDMP©) Handbook that align with the core CCDA exam
domains and associated tasks.

This guide also shows the domains and tasks that are regulated by the ICH
GCP guidelines.

Please note this document is a supplemental study aid. It does not

replace review of the GCDMP Handbook and ICH GCP guideline.

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CONTENTS

1. CCDA Exam Domains and Tasks 4

> Design Tasks 4
> Tasks 4
> Applicable GCDMP Chapters 4
> Applicable ICH GCP Guidelines 4
> Programming and Testing Tasks 5
> Tasks 5
> Applicable GCDMP Chapters 5
> Applicable ICH GCP Guidelines 5
> Data Processing Tasks 6
> Tasks 6
> Applicable GCDMP Chapters 6
> Applicable ICH GCP Guidelines 6
> Training Tasks 7
> Tasks 7
> Applicable GCDMP Chapters 7
> Applicable ICH GCP Guidelines 8
> Coordination & Management Tasks 11
> Tasks 11
> Applicable GCDMP Chapters 11
> Applicable ICH GCP Guidelines 12
> Review Tasks 13
> Tasks 13
> Applicable GCDMP Chapters 13
> Applicable ICH GCP Guidelines 14

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2. GCDMP Chapters - Minimum Standards and Best Practices 15

> Data Entry Process 15
> Data Management Standards in Clinical Research 17
> Data Privacy 18
> Database Closure 19
> Database Validation, Programming, and Standards 20
> Design and Development of Data Collection Instruments 21
> Edit Check Design Principles 22
> Electronic Data Capture - Concepts and Study Start-up 23
> Electronic Data Capture - Study Closeout 26
> Laboratory Data Handling 28
> Measuring Data Quality 30
> Medical Coding Dictionary Management & Maintenance 31
> Project Management for Clinical Data Manager 33
> Serious Adverse Event Data Reconciliation 35
> Vendor Selection and Management 37
> Vendor Selection and Management (Released 2021) 39

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1 CCDA Exam Domains and Tasks

Design Tasks

Tasks
1. Assist with implementing data standards
2. Assist in the design of the data collection forms
3. Read and interpret annotated forms
4. Assign in design of edit checks
5. Understand data transfer specifications
6. Create specifications for reports

Applicable GCDMP Chapters

1. Assist with implementing data standards

5. Understand data transfer specifications

3. Read and interpret annotated forms

6. Create specifications for reports

2. Assist in the design of the data

GCDMP Chapter 4. Assist in design of edit checks

collection forms

Database Validation, Programming, and Standards

Design and Development of Data Collection Instruments

Edit Check Design Principles

Electronic Data Capture—Concepts and Study Start-up

Laboratory Data Handling

Metrics for Clinical Trials

Applicable ICH GCP Guidelines

There are no applicable ICH GCP guidelines for this domain.

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Programming and Testing Tasks

Tasks
1. Build data visualizations
2. Test visualizations and reports
3. Executes UAT of EDC/eCOA study-specific configuration
4. Basic understanding of SQL and programming knowledge (R, Python, and
Magro)
5. Understand the types of programming tools that are available for data review,
data reporting, and data analysis
6. Runs simple import/export programs

Applicable GCDMP Chapters

programming knowledge (R, Python and

5. Understand the types of programming

6. Runs simple import/export programs

3. Executes UAT of EDC/eCOA study-

4. Basic understanding of SQL and

2. Test visualizations and reports

tools that are available for

1. Build data visualizations

GCDMP Chapter specific configuration

Database Validation, Programming, and Standards

Design and Development of Data Collection Instruments

Edit Check Design Principles

Electronic Data Capture—Concepts and Study Start-up

Electronic Data Capture—Study Closeout

Reports and Metrics

Applicable ICH GCP Guidelines

There are no applicable ICH GCP guidelines for this domain.

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Data Processing Tasks

Tasks
1. Collect study data (Paper Process) including local lab ranges
2. Enter data (Paper Process)
3. Write simple queries

Applicable GCDMP Chapters

1. Collect study data (Paper process)

2. Enter data (Paper Process)

including local lab ranges
GCDMP Chapter

3. Write simple queries

Data Entry Processes

Data Privacy

Design and Development of Data Collection Instruments

Edit Check Design Principles

Electronic Data Capture—Concepts and Study Start-up

Laboratory Data Handling

Applicable ICH GCP Guidelines

There are no applicable ICH GCP guidelines for this domain.

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Training Tasks

Tasks
1. Support creation of investigator site training materials
2. Demonstrate proficiency in Good Clinical Practice (GCP)
3. Understand Drug Development process
4. Understand and apply ALCOA+ principals
5. Understand data privacy laws
6. Understand randomization and study blinds
7. Understand primary and secondary endpoints including critical variables
8. Review and understand SOPs
9. Review and understand Protocol
10. Understanding the purpose of data standards
11. Understanding the purpose of coding dictionaries
12. Understand the data flow from initial entry through CSR
13. Awareness of different roles to maintain the blind
14. Understand TMF Reference Model and company-specific implementation
15. Awareness of study documentation completeness in TMF Data Management zone

Applicable GCDMP Chapters

completeness in TMF Data Management

4. Understand and apply ALCOA+ principals
3. Understand Drug Development process

12. Understand the data flow from initial

15. Awareness of study documentation

10. Understanding the purpose of data
2. Demonstrate proficiency in Good

9. Review and understand Protocol

11. Understanding the purpose of

5. Understand data privacy laws

8. Review and understand SOPs

Clinical Practice (GCP)

GCDMP Chapter
coding dictionaries

entry through CSR

standards

Design and Development of Data Collection Instruments

Data Management Standards in Clinical Research

Data Privacy

Electronic Data Capture—Concepts and Study Start-up

Laboratory Data Handling

Medical Coding Dictionary Management & Maintenance

Project Management for the Clinical Data Manager

Vendor Selection and Management

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Training
Sponsor
ICH GCP

Investigator
Data Privacy

Ethics Committee

Principles of ICH GCP

Investigator's Brochure
Confidentiality of Records

Laboratory Data Handling

ICH GCP Topic

Data Governance - Investigator and Sponsor

Data Management Standards in Clinical Research

Essential Records for the Conduct of a Clinical Trial

Essential Documents for the Conduct of a Clinical Trial

Medical Coding Dictionary Management & Maintenance

Applicable ICH GCP Guidelines
2024 CCDA Exam Study Guide

Appendix B. Clinical Trial Protocol and Protocol Amendment(s)

1. Support creation of investigator
site training materials

2. Demonstrate proficiency in
Good Clinical Practice (GCP)

3. Understand Drug Development process

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4. Understand and apply ALCOA+ principals

6. Understand randomization
and study blinds

7. Understand primary and secondary

endpoints including critical variables

9. Review and understand Protocol

10. Understanding the purpose of

data standards
13. Awareness of different roles
to maintain the blind

14. Understand TMF Reference Model and

company-specific implementation

15. Awareness of study documentation

completeness in TMF Data Management
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ICH GCP Topic Applicable ICH GCP Guideline

ICH E6(R2), Chapter 2

Confidentiality of Records The confidentiality of records that could identify subjects

should be protected, respecting the privacy and
confidentiality rules in accordance with applicable
regulatory requirement(s).
Data Governance - Investigator and Sponsor ICH E6(R3), Chapter 4 [Draft]

Data Management Standards in Clinical M2 Electronic Standards, M2 EWG Electronic Standards for
Research* the Transfer of Regulatory Information

ICH E6(R2), Chapter 2

Data Privacy The confidentiality of records that could identify subjects

should be protected, respecting the privacy and
confidentiality rules in accordance with applicable
regulatory requirement(s).
Essential Documents for the Conduct of
a Clinical Trial ICH E6(R2), Chapter 8

Essential Records for the Conduct of a

Clinical Trial ICH E6(R3), Appendix C [Draft]

Ethics Committee ICH E6(R2), Chapter 3

ICH GCP ICH E6(R3), Chapter II [Draft]
Investigator ICH E6(R2), Chapter 4
Investigator's Brochure ICH E6(R2), Chapter 7

ICH E6(R2) Chapter 8

Normal value(s)/range(s) for medical/laboratory/technical

procedures(s) and/or test(s) included in the protocol to be
located in the files of the investigator/institution and sponsor
to document normal values and/or ranges of the tests.
Laboratory Data Handling
Updates to normal value(s)/range(s) for medical
laboratory/technical procedures(s)/test(s) included in the
protocol to be located in the files of the
investigator/institution and sponsor to document normal
values and ranges that are revised during the trial.

M1 MedDRA Terminology (Multidisciplinary Guideline),

Medical Coding Dictionary MedDRA – Medical Dictionary for Regulatory Activities
Management & Maintenance*
M1 PtC WG, MedDRA Points to Consider

Principles of ICH GCP ICH E6(R3), Chapter II [Draft]

Sponsor ICH E6(R2), Chapter 5

ICH E6(R2), Chapter 2

Training Each individual involved in conducting a trial should be

qualified by education, training, and experience to
perform his or her respective task(s).

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The ICH GCP Guidelines are available here:

ICH_E6(R2) Guideline: ICH_E6(R2) Guideline
ICH_E6(R3) Guideline: ICH_E6(R3) Guideline
Index of ICH Guideline: Index-ICH Guidelines
ICH Guidelines by Category: ICH Guidelines by Category
Multidisciplinary Guidelines: Multidisciplinary Guidelines

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Coordination & Management Tasks

Tasks
1. Assist with system and data management startup
2. Assist and report on data collection and processing
3. Assist with site data close-out
4. Assist with tasks required for database lock
5. Assist with implementation of new system
6. Supporting summary of data trends
7. Assists in creating study storyboards as part of inspection readiness
8. Assists in document retrieval during inspections

Applicable GCDMP Chapters

5. Assist with implementation of new system

7. Assists in creating study storyboards

6. Supporting summary of data trends

as part of inspection readiness

3. Assist with site data close-out

8. Assists in document retrieval

4. Assist with tasks required for
1. Assist with system and data

collection and processing

2. Assist and report on data

GCDMP Chapter
management startup

during inspections
database lock

Data Privacy

Database Closure

Database Validation, Programming, and Standards

Design and Development of Data Collection Instruments

Edit Check Design Principles

Electronic Data Capture—Concepts and Study Start-up

Electronic Data Capture—Study Closeout

Laboratory Data Handling

Medical Coding Dictionary Management & Maintenance

Project Management for the Clinical Data Manager

Reports and Metrics

Serious Adverse Event Data Reconciliation

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Applicable ICH GCP Guidelines

There are no applicable ICH GCP guidelines for this domain.

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Review Tasks

Tasks
1. Review protocols and study plans (e.g. data management plan, project
management plan, safety management plan, site monitoring plan)
2. Review reports for inconsistencies in the data
3. Review work of peers
4. Identify data driven protocol deviations
5. Performs simple QC of study documentation content (e.g. version control)
6. Understand the different data types

Applicable GCDMP Chapters

safety management plan, site monitoring plan)

management plan, project management plan,

documentation content (e.g. version control)

1. Review protocols and study plans (e.g. data

4. Identify data driven protocol deviations

6. Understand the different data types

2. Review reports for inconsistencies

5. Performs simple QC of study

GCDMP Chapter
3. Review work of peers
in the data

Data Entry Processes

Data Privacy

Database Closure

Design and Development of Data Collection Instruments

Edit Check Design Principles

Electronic Data Capture—Concepts and Study Start-up

Electronic Data Capture—Study Closeout

Laboratory Data Handling

Measuring Data Quality

Project Management for the Clinical Data Manager

Serious Adverse Event Data Reconciliation

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Applicable ICH GCP Guidelines

There are no applicable ICH GCP guidelines for this domain.

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2 GCDMP Chapters – Minimum Standards and Best Practices

Data Entry Processes

Minimum Standards
Utilize written procedures describing data flow, data entry, data processing,
and required quality level. Ensure enough specificity to reproduce the analysis
database from source documentation.
Ensure employees are appropriately trained (including ICH-specified
documentation of having been trained) on systems, procedures, guidelines,
working practices, and appropriate references (e.g., materials such as medical
dictionaries, medical abbreviations, etc.) and that these documents are current
and available to employees throughout the course of the study.
Ensure all personnel involved with data entry or data management have the
proper levels of access, grants and privileges.
Maintain a list of individuals who are authorized to make data changes.
Apply quality control to each stage of data entry processes to ensure data are
reliable and processed correctly.

Best Practices
Address the purpose, characteristics and complexity of each study in data
entry training sessions, including, but not limited to a brief review of the
protocol, scope of work, and identification of critical variables (usually privacy
controlled subject identifiers, primary and secondary efficacy variables, and
safety information).
Verify in a test environment (before the data entry system is placed into active
use) that entry fields function as planned (e.g., date fields only accept dates,
drop-down lists contain appropriate values, skip patterns function properly). In
some organizations, true test data pages may be entered for an entire case
report form (CRF) packet, while other organizations may perform more focused
testing. This is not to be considered a substitute for software validation or edit
check testing.
Provide comprehensive user training on CRF completion guidelines and data
entry instructions.

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Provide sites, sponsors, vendors and study team members with timeline
expectations for data receipt, data tracking, data entry, and turnaround times
for data queries, file transfers and database deliverables.
Establish thorough tracking mechanisms for the receipt of CRFs and other
forms containing data to be entered. Tracking ensures control of the received
records, identifies missing records and facilitates the archival of records at the
end of the study.
Establish database quality criteria, including a quality control plan that
appropriately addresses primary efficacy and safety data.
Monitor data entry functions while in active use to identify trends and ensure
stable and desirable quality levels are consistent with study needs.
Create and maintain comprehensive processes for change control.

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Data Management Standards in Clinical Research

Minimum Standards
Use the most current version of any standard, if appropriate.
Use standards required by regulatory agencies in the country where the study
is conducted.
Do not modify published standards.

Best Practices
Use accepted standards whenever possible, and strive for interoperability.
Use all standards recommended by regulatory agencies in the locale of the
study.
Review implementation guidelines for any standard having associated
guidelines documents.

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Data Privacy

Minimum Standards
Use the most current version of any standard, if appropriate.
Use standards required by regulatory agencies in the country where the study
is conducted.
Do not modify published standards.

Best Practices
Use accepted standards whenever possible, and strive for interoperability.
Use all standards recommended by regulatory agencies in the locale of the
study.
Review implementation guidelines for any standard having associated
guidelines documents.

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Database Closure

Minimum Standards
Establish clearly documented procedures defining all steps of database lock,
database closure, and unlocking and relocking the database after database
closure.
Clearly define all roles with respective responsibilities involved with database
lock and closure procedures.
Prior to database lock (interim, soft, or final) or database closure, ensure
documentation of all defined tasks or criteria has been completed.
At final database lock, ensure all team members are notified and access that
allows database changes is removed and documented.

Best Practices
Clearly define all terms relating to interim lock, soft lock, final lock, database
unlock and final database closure.
Develop and utilize a database closure checklist.
Maintain documentation and approval or acknowledgement documents
requiring signatures of all responsible parties involved in database lock, unlock
and closure procedures.
Where indicated, plan an interim or soft lock with a statistical analysis and data
review prior to the final lock. This review may identify potential data errors,
preventing the need to unlock the database after the final lock.

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Database Validation, Programming, and Standards

Minimum Standards
Generate a validation plan defining the testing methodology, scope, problem
reporting and resolution, test data, acceptance criterion and members of the
validation team.
Ensure the CDMS meets user/functional and regulatory requirements and
continues to meet these requirements through the course of its use.
Implement the CDMS carefully, testing according to specifications,
documenting all testing and issues, and ensuring objective evidence of testing
is generated.
Define processes for handling change control issues, with a clear determination
of when revalidation will be required due to changes.
Document all validation details prior to implementation in a summary document
(e.g., validation report), including all applicable review and approval signatures.
Ensure documentation remains complete and current.
Ensure that only qualified staff develop, maintain and use the system.
Approval of validation plan and documented results from an appropriate level of
independent quality resource(s).

Best Practices
Identify all intended user requirements of study-specific programming.
Use organization standards, as available, to prepare study-specific
programming.
Use organization standards to document programs.
Use code libraries wherever possible.
Confirm that study-specific programming applications perform as intended
based on the user requirements (data management plan requirements, CRF
requirements, database specifications, edit check specifications, validation
plan, etc.).
Document performance during validation.
Ensure documentation remains complete and current for live use, and is
indexed for ready retrieval when it is retired or archived.
Confirm accuracy, reliability, performance, consistency of processing and the
ability to identify invalid or altered records. Confirm through testing and
document.
Ensure the system has an appropriate traceability matrix linking test cases to
requirements.
Confirm that the study-specific application has been configured properly.

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Design and Development of Data Collection Instruments

Minimum Standards
Design CRFs to collect the data specified by the protocol.
Document the process for CRF design, development, approval, and version
control.
Document training of clinical site personnel on the protocol, CRF completion
instructions and data submittal procedures prior to subject enrollment.
Verify CRFs based on rating instruments created by an independent source
(e.g. Health Status Questionnaire, Beck Depression Inventory, etc.), have been
properly licensed for use and follow prescribed formatting or copyright
requirements.
Ensure CRFs are available at the clinical site prior to enrollment of subjects.

Best Practices
Establish and maintain a library of standard forms and associated edit checks
(CRFs, CRF completion guidelines, subject diaries, etc.).
Use a multidisciplinary team to provide input into the CRF design and review
processes. Data entry personnel, biostatisticians, the internal study team, and
clinical operations personnel may be able to provide valuable perspectives to
help optimize CRFs.
Design CRFs with safety and efficacy endpoints in mind. Consult the protocol,
study biostatistician(s) or review the statistical analysis plan (SAP) (if available)
to ensure all key endpoints are collected.
Keep the CRF’s questions, prompts, and instructions clear, concise and
conformant to CDISC CDASH standards, where possible.
Design the CRF to follow the data flow from the perspective of the person
completing it, taking into account the flow of study procedures.
Whenever possible, avoid referential and redundant data points within the CRF.
If redundant data collection is used to assess data validity, the measurements
should be obtained through independent means.
Use carbonless copy paper (NCR) paper or other means to ensure exact
replicas of paper collection tools.

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Edit Check Design Principles

Minimum Standards
Finalize protocol and complete initial database specifications prior to designing
edit checks.
Specify edit checks based on parameters of case report form (CRF) pages and
safety and efficacy parameters from the protocol.
Specify edit checks for all primary study endpoints and safety data.
If applicable, specify edit checks with external data (e.g., laboratory data) for
reconciliation purposes.
Ensure all edit checks are programmed, validated, and documented in
accordance with established standard operating procedures.
Ensure all edit checks specification documents are appropriately version
controlled.
Provide training to relevant personnel on the impact of edit checks on their
individual roles in entering and managing clinical data.

Best Practices
Where appropriate, specify edit checks to compare study inclusion and
exclusion criteria and any data (that are collected in CRF pages) that could be
indicative of protocol violations.
Design edit check specifications so redundant output does not occur when edit
checks are run.
Review edit checks with appropriate clinical and statistical personnel to ensure
edit checks meet study needs and help identify inconsistencies in study
endpoints.
Specify edit checks for all study endpoints and all data supporting safety data
and study endpoints.
Develop a library of standard CRFs and edit checks based on standards used,
such as CDASH or company-specific standards.
Perform a quality control review of edit check design and specifications prior to
performing user acceptance testing (UAT) of edit checks.
Evaluate the effectiveness of edit checks once in active use, and modify, delete
or create new edit checks accordingly.

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Electronic Data Capture—Concepts and Study Start-up

Minimum Standards
Ensure compliance with 21 CFR 11 and consistency with the Food and Drug
Administration’s (FDA) Guidance for Industry: Computerized Systems Used in
Clinical Trials.
Stated quality standards should support the utilization of automated data
capture, management and archiving.
Ensure requirements are defined for data transfers and integration with other
systems.
Software systems validation should be scheduled and completed prior to EDC
study implementation.
Ensure user acceptance testing (UAT) is completed prior to implementation and
deployment to sites.
Verify training is provided for all users of the EDC systems and that all training is
documented and minimum competencies are met.
Verify access to data is limited to authorized individuals.
Determine roles and responsibilities in data review and query management.
Software technical support should be provided to users and a toll free phone
number should be available for the help desk.
Ensure sites have access and control of data up to database lock.

Best Practices
Use business process analysts (possibly external, for objectivity) to establish
EDC-specific workflow processes and identify required transitions from current
processes.
Do not apply paper study processes to studies using EDC.
Identify stakeholders in current processes, as well as additional stakeholders
required for new EDC processes.
Plan studies to avoid “last minute” system modifications that introduce errors
and complexity to study-specific CRFs.
Develop CRFs or data collection tools with teams of individuals from monitoring,
data management, statistics, regulatory affairs, and medical, ensuring
adequate attention to the collection of safety data.
Ensure systems are user-friendly and flexible for data entry.
Ensure EDC systems do not restrict answers site staff can provide in a way that
introduces bias into the clinical study.

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Ensure adequate edit check procedures and query management tools are built
into EDC software.
Before the start of a study, conditions (e.g., SDV completed, all queries resolved)
for locking forms and/or casebooks should be set according to a set of criteria,
such as, all SDV complete, all data review complete, no outstanding queries or
missing data exist.
When coding in an EDC environment it is recommended not to display coded
terms back to the site user.
Ensure data can be traced from the time of original input through the reporting
and analysis files via easily accessible audit trails.
Ensure ease and quality of all data transfers by testing data transfers prior to
deployment of EDC systems.
Ensure your EDC system integrates as needed with other databases by testing
integrations with your EDC system prior to initiating any trials using the system.
Ensure processes are defined to integrate laboratory and other non-CRF data
with data obtained from the CRF.
Ensure all user acceptance tests are documented.
Ensure change control procedures include complete documentation.
Ensure all documentation for use by site staff is adequately reviewed before
being provided to site staff.
If 24 x 7 x 365 support is not available, the help desk should cover the work
days/times of all regions included in the study.
The help desk should support the minimum number of languages needed to
communicate with all users and all languages, including local dialects.
Develop and follow standard operating procedures (SOPs) for electronic data
capture, data validation, and data archiving.
Assess current SOPs for potential impact created by EDC workflow processes
and update SOPs as necessary.
Include SOP modification time in project plans for EDC implementation.
Assume that both the new workflow and SOPs will be in transition for some
period of time as the staff interact with the EDC system following any
modification of SOPs.
Verify all users have documented training prior to being granted access to the
system.

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Create a training environment in which users can practice, and create training
cases as examples that are pertinent to the study.
Provide a “Train the Trainer” program for clinical research associates (CRAs),
data managers or others to be able to provide training to sites.
Provide training customized to each user’s role. A study coordinator may need
in-depth training of most system functions, while users with read only access
may need minimal instructions.
Document all training for trial master files as well as site files.
Integrate metrics on process and cost/benefit into the EDC process to enable
better EDC versus non-EDC comparisons and comparisons across EDC
technologies.
CRF specifications should be finalized prior to finalization of edit check
specifications, although development of both should be performed concurrently

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Electronic Data Capture—Study Closeout

Minimum Standards
Ensure completion of all required source document verification and data
review.
Ensure all investigator signatures (principal and sub) are in place at closeout.
Ensure the procedures established for locking fields or forms in a CRF have
been followed, including those with open queries or unreviewed and/or
unverified status.
Perform a final review of data listings to identify and resolve any remaining data
discrepancies that may generate queries.
Perform a final review of query status for both open and answered queries
through reports and task summaries.
Ensure defined procedures have been followed for locking the database, and
for unlocking the database if necessary.
Ensure defined processes have been followed for restricting user access once
the database is locked, and for revoking access to the production database.
Ensure adherence to definitions of the audit plan and post audit data transfer
process, as well as identifying audit team members well before study closeout.
Define specifications for formatting subject profiles, as well as a process for
generating and reviewing subject profiles.
Ensure investigative sites have access to their CRF data after study completion.
Once they have received the appropriate media for this data, their access to
corresponding data in the EDC system can be revoked.
Ensure any hardware provided to sites is retrieved according to organization
standard operating procedures (SOPs).
Determine requirements for creating additional media to represent the study
database if needed.

Best Practices
Use business process analysts (possibly external, for objectivity) to establish
EDC-specific workflow processes and identify required transitions from current
processes.
Implement a verification procedure to ensure data received or extracted from
the database matches data entered in CRFs, especially in cases where
additional output programming is conducted. This practice confirms integrity of
the data being released for statistical analysis.

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Review and refine the source data verification timeline with monitors and
clinical operations after the last subject visit occurs and data entry is
completed, (In some cases these processes can also be performed prior to the
last subject visit).
Ensure all medical coding activities have occurred as required.
Use an incremental form or casebook lock strategy to reduce the amount of
data review and locking needed upon study completion.
Ensure all tasks documented in the data management plan are complete, and
coordinate with clinical operations personnel to ensure all site monitoring
activities are complete prior to database lock.
Use an established checklist of tasks to be completed prior to database lock in
order to meet database lock timelines.
In preparation to meet database lock deliverables, adjust timelines as needed
for all queries to be answered by sites.
Use an established communication plan between the clinical team, site staff,
statisticians, and data management. This communication plan should ensure all
data reviews are completed and queries are answered in time to meet
database lock deliverables.
Create a calendar of vacations or out of offices for all team personnel to ensure
proper resources are available for study close out activities.
Review current regulatory standards and guidelines for how data should be
presented in the subject profile (e.g., headers, footers, and margins).
Determine the appropriate media to use for reporting of subject profile data.

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Laboratory Data Handling

Minimum Standards
Maintain standard operating procedures (SOPs) for all processes relating to lab
data collection, transfer, and validation of data loading and data feasibility.
Identify labs involved with a study as early in study setup as possible.
Use standardized names for lab tests and units.
Ensure reference ranges are defined prior to first data receipt when using a
central lab.
Where possible, ensure reference ranges are defined prior to first data receipt
when using a local lab.
Ensure updates to reference ranges are obtained and implemented in a timely
fashion.
Document all data transfer specifications thoroughly when using labs
transferring data electronically.
Determine software/hardware required to access data prior to a test transfer
and ensure the format of the data medium is compatible.

Best Practices
Use accepted standards such as those from Clinical Data Interchange
Standards Consortium (CDISC) when possible.
Define all lab data standards prior to beginning data collection.
Ensure reference ranges are defined for population subgroups (e.g., ethnicity)
that differ significantly from other defined groups or subgroups.
Implement a standard process to collect and archive reference range data.
Use a standard method of data review for local lab data and reconciliation of
central lab data.
Develop a data transfer agreement for electronic transfers and perform quality
control of the test transfer.
Document and confirm all lab variables prior to signing off on data transfer
specifications.
Implement a conversion factor table to standardize conversion of conventional
units to the International System of Units (SI).
Define edit checks for inclusion/exclusion criteria based on lab data and route
to appropriate team members to review.
Use standardized units so that performing edit checks on converted data
produces a more consistent review of results.

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Send requests for central lab data corrections using a formalized process, for
example, on a correction log sent to the lab vendor to update and return after
correcting and resubmitting the lab data file.
Implement a system to manage data collected outside protocol parameters.

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Measuring Data Quality

Minimum Standards
Use statistically appropriate inspection sample sizes for decision making.
Document the method and frequency of data quality assessments in the study’s
data management/quality plan.
Perform at least one quality assessment of the study data prior to final lock.
Document data quality findings and corrective actions, if needed.
Determine acceptable error rates for primary and secondary safety and
efficacy (also known as “critical”) variables.

Best Practices
Use quantitative methods to measure data quality.
NOTE: Quantitative methods for measuring data quality involve classifying the
data, counting the data, and constructing statistical models to help explain
database quality, database errors, and patterns of errors. Database errors, or
“findings”, can be generalized to the entire data set, and direct comparisons
can be made between the sample and the whole data population as long as
valid sampling and significance techniques are used. Quantitative methods help
differentiate between data errors that might be pervasive in the data set and
errors that are merely random occurrences.
Compare trial data and processes in the beginning, middle, and end stages of
the trial.
Work with clinical operations to predefine criteria to trigger site comparisons
based on monitoring reports.
Perform quality control on 100% of key safety and efficacy (critical) variables.
Monitor aggregate data by site to detect sites whose data differ significantly so
that appropriate corrective actions can be taken.
Perform quality control prior to release of data used for decision making.

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Medical Coding Dictionary Management & Maintenance

Minimum Standards
Select dictionaries that meet project and regulatory requirements.
Follow established security procedures for dictionary installation and
maintenance.
Ensure user licenses are obtained and kept up to date for any dictionaries and
applications used.
Ensure all sponsor personnel and vendors who will use the dictionaries hold the
appropriate licenses. If a vendor has access to the dictionary application,
ensure the application license covers vendor access.
Implement an audit trail for all changes/updates to the dictionaries or synonym
listings and support tables associated with the dictionaries.
Do not modify published commercially available coding dictionaries. If a
commercially published dictionary has been modified, then do not refer to it by
its commercially available product name.
Specify the dictionary name and dictionary versions used during coding on all
study reports and integrated summaries.
Store all utilized versions of dictionaries for future reference.

Best Practices
Select a coding tool to facilitate consistent dictionary use.
Include the version(s) of utilized dictionaries in metadata.
Ensure all levels and versions of dictionaries used for coding can be accessed
by data management and other dictionary users.
Establish a process for evaluating term or categorization changes in a
dictionary and its effect on previously coded data when moving to a different
version.
Ensure the capability to recode to different versions of a dictionary. For
example, this may be needed to allow integrated study analyses to be reported
using the same version.
Ensure individuals who code data have training and professional background
appropriate to the dictionary and the version for which they are coding. Training
must be completed and documented before coding with the dictionary or
version.
Educate individuals involved in recording, monitoring, reviewing, analyzing and
reporting coded data on the functionality and capabilities of the coding
dictionaries used.

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Submit requested dictionary changes to the organizations responsible for

maintaining the dictionaries using the appropriate approved process of
submitting changes.
Ensure change control processes are in place for all dictionaries, whether
commercially available or custom.

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Project Management for the Clinical Data Manager

Minimum Standards
Identify all data management study team members, stakeholders, and
respective alternates wherever possible and as early in study setup as
possible. Ensure information is documented and updated regularly, with
documentation centrally located or otherwise easily accessible to the study
team regardless of their physical location. Clearly identify the individual(s)
responsible for information updates. For an example of what should be included
in a project plan, see Appendix A: Sample Project Plan Template.
Identify, define, and document all study-specific processes. Any planned study-
specific deviations from organizational SOPs and the rationale for the deviations
should be brought to the attention of quality assurance personnel and logged
for discussion during future SOP review cycles.
Ensure clear, comprehensive, and technically feasible timelines with
dependencies that are created and documented such that all personnel are in
agreement and can access timelines relative to their scheduled tasks. This may
take the form of Gantt charts (derived from a project plan).
Monitor, track and document projected costs and timelines against actual
expenditures and deliveries (e.g., comparison of percentage of work completed
to the percentage of budget spent).
Identify potential risks to the project or study. Develop early warning signals and
response strategies for each identified risk (e.g., risk mitigation plan). Review
and adjust study-specific contingencies in accordance with study life cycle.
Create and propose to the project team a communication plan, which, upon
approval, shall be adhered to by all study personnel and stakeholders. The plan
should be specific and easy to follow based on individual end user needs. The
plan should identify a schedule for routine communications, the means by
which these communications will be conducted, and how communications will
be documented and archived.
Common elements may include issue categories and associated severity
codes, severity-based time/resource/cost impact, escalation rules, and
resolution plans. For an example of what should be included in a
communication plan, see Appendix B: Sample Communication Plan Template.
Assure a thorough assessment has been made of CDM team members’
familiarity with clinical study processes, disciplines, or functional lines.
Ensure appropriate project- or study-specific training is delivered, maintained
and documented for all study personnel performing CDM tasks.

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Ensure adequate and compliant electronic, virtual, and physical resources will
be available for intake and archival of final accepted CDM deliverables. This
may involve working with personnel from different departments, including
information technology (IT), legal, and regulatory operations, as well as external
vendors.

Best Practices
Create a responsibility matrix that describes activities to be conducted during
the course of the study.
Conduct regular meetings with the study team (may be conducted via Web or
telephone conferences). During these meetings, track progress and upcoming
milestones, and discuss corrective actions if needed.
Continually assess project processes and modify processes as needed to
function more efficiently. Ensure all process changes are communicated,
documented, and version controlled. File this documentation within the study
master file in effort to establish a clear audit trail.

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Serious Adverse Event Data Reconciliation

Minimum Standards
Create entry and edit instructions, including deletion and change control
procedures.
Standardize the capture of SAE data elements in both the clinical database and
the safety database.
Conduct the reconciliation of event terms so they are at least similar if not
exactly the same.

Best Practices
Establish the time intervals in the project where reconciliation will be performed
and in particular the mechanisms to cover interim analyses or safety data
reporting. Often SAEs continue to be reported after a clinical trial has
concluded. Some companies collect information in a single database and some
companies collect information in two separate databases: a safety database
and a clinical database. It is important to establish a cutoff point after which no
SAEs will be added to the clinical database, even if the safety data or safety
database is updated.
Identify the data items to be reconciled. This may include, but not be limited to
the following:
Protocol Verbatim
Investigator Coded or preferred term
Subject identification Onset date
Randomization number Resolution date
Initials Date of death
Date of Birth Outcome
Gender Severity
Race Causality assessment
Event number Action taken with study drug
Diagnosis
Sometimes data items are used from other modules for further reconciliation or
clarification.
From the demography module, items used may include but not be limited to the
following:
Subject identification
Weight

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Date of birth
Gender
Race
From the discontinuation module, items used may include but not be limited to
the following:
Subject identification
Primary reason for discontinuation being an event
Cause of hospitalization
Cause of death listed on the death certificate
Autopsy result
From the concomitant medications module, items used may include but not be
limited to the following:
Subject identification
Medication name
Start date
Stop date or ongoing
Indication
When possible, customize database fields used in reconciliation to be
programmatically compared without compromising the integrity of the software
or databases. Even programmatic reconciliation of fewer than 100 events can
be cost effective in both time and quality. The process can be validated once
and run as frequently as data and time allow.
When initiating the reconciliation process, clinical data management should
confirm that all data to be included in the reconciliation have been entered and
validated. Clinical data management should also confirm that any data
clarifications have been returned and applied to the clinical database, and that
the coding of AE verbatim terms against the common dictionary has been
completed.
Clinical data management, safety leads, and clinical operations should
establish a mutually agreeable turnaround time for researching, retrieving, and
correcting any discrepancies found during or since the last reconciliation
period.
Read–write access to either database (but not both) is granted to personnel
trained in data entry for the purpose of and whose responsibilities include data
entry, data modification, or data validation. Read–only access is granted to
personnel related to reconciliation, but who are not directly responsible for
those tasks related to data modification. System administration rights are
limited to personnel responsible for database configuration.

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Vendor Selection and Management

Minimum Standards
Document the sponsor’s process and support functions that are needed to
evaluate the use of vendor services.
Evaluate and qualify (e.g., capacity, qualifications, experience, regulatory
compliance, company stability, etc.) vendors prior to contracting for their
services or products.
Obtain a confidentiality agreement with the vendor prior to exchange of
proprietary information.
Create a contacts list that is centrally accessible to study team members.
Determine and document whether the sponsor’s or vendor’s standard
operating procedures (SOPs) (or a combination of procedures) are to be
followed.
Clearly define expectations, deliverables and responsibilities. Both the sponsor
and the vendor must participate in establishing definitions of their roles.
Conduct ongoing management of vendor activities. Communicate and assess
the vendor’s performance throughout the study.

Best Practices
Where feasible, evaluate from a CDM perspective the risk of utilizing or not
utilizing vendor services related to the conduct and outcome of the study.
Maintain an internally approved vendor list with regular evaluations (e.g.,
preferred vendor list or prequalified vendor list).
Establish a cross-functional vendor auditing program based on established
services, which should include plans to re-audit the vendor within a stated
amount of time, if applicable.
Oversee vendors by utilizing subject matter experts within a centralized
organizational team to provide input into the processes of vendor evaluation,
vendor audits, and issue resolution and escalation.
Define and document a detailed statement of work and project plans that detail
who is responsible for each task; who is responsible for reviewing and
approving various documents; details of project reporting; or a checklist of
tools, processes, and services to be performed by the sponsor and vendor at
each phase of the study.
Define and document detailed sponsor/vendor communication plans that
clearly address the expected communication tools and frequency, as well as
establish who is responsible for communications and how to escalate issues
when deemed necessary.

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Identify other possible vendors or options as part of a contingency plan in case

the vendor relationship is deemed unsatisfactory at any point during the course
of the study.
Establish a collaborative relationship based on partnership, trust and
coownership of the project.
If the vendor is providing services that involve computerized systems, ensure
system support documentation is in place, such as a service level agreement
(SLA), that describes in detail how much time it will take the vendor to respond
to support inquiries, how long it will take to get a database back online in case of
a system failure, and other details related to supporting the sponsor’s business
requirements.

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Vendor Selection and Management (Released 2021)

Minimum Standards
Sponsors should assess a vendor’s Quality Management System and deem it
appropriate prior to receiving goods or services toward a clinical study.
Decisions made in the course of such an assessment may be risk-based.
Sponsors should assess potential impact of contracted work on human subject
protection and reliability of trial results.
Sponsor responsibilities delegated to a vendor should be documented in
writing.
Sponsors should establish a vendor-auditing program including plans to and
criteria for re-audit.
Sponsors who contract goods or services toward a clinical study should
provide adequate oversight.

Best Practices
Obtain a confidentiality agreement with the vendor prior to exchange of
proprietary information.
Document the sponsor’s process and support functions needed to evaluate the
use of vendor services.
Evaluate and qualify, e.g., by capacity, capability, qualifications, experience,
regulatory compliance, company stability, vendors prior to contracting for their
services or products.
Create a contacts list that is centrally accessible to study team members.
Determine and document whether the sponsor’s, the vendor’s, or a
combination thereof standard operating procedures (SOPs) are to be followed.
Clearly define expectations, deliverables, and responsibilities.
Conduct ongoing management of vendor activities by communicating and
assessing the vendor’s performance throughout the study.
Review data transfer agreement for all the third party vendors.
Where feasible, evaluate from a CDM perspective the risk of utilizing or not
utilizing vendor services related to the conduct and outcome of the study.
Maintain an internally approved vendor list (Template available in Appendix A)
with regular evaluations (e.g., preferred vendor list or prequalified vendor list).
This may be risk-based.
The vendor-auditing program should be cross-functional based on contracted
services.

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Processes for vendor evaluation, vendor audits, issue resolution, and escalation
should be informed by cross-functional subject matter experts within a
centralized organizational team. Use a subject matter consultant if your
organization lacks this expertise in-house.
Define and document a detailed statement of work and project plans that
delineate each task, role or person responsible, task timing and dependencies,
related documentation, role or person responsible for reviewing and approving
related documentation or other task results, and reporting related to the task.
Define and document detailed sponsor/vendor communication plans that
clearly address the expected communication tools and frequency, as well as
establish who is responsible for communications and how to escalate issues
when deemed necessary.
In high risk situations, identify other possible vendors or options as part of a
contingency plan in case the vendor relationship is deemed unsatisfactory at
any point during the course of the study.
Establish a collaborative relationship based on partnership, trust, and
coownership of the project.
Hold frequent one-on-one meetings or teleconferences with the vendor lead to
share concerns, provide mutual feedback, plan for success, and ensure
activities are on track without any red flags.
If the vendor is providing services that involve computerized systems, ensure
system support documentation is in place. For example, establish a service
level agreement (SLA), that describes in detail how much time it will take the
vendor to respond to support inquiries, how long it will take to get a database
back online in case of a system failure, and other details related to supporting
the sponsor’s business requirements.
Study teams should engage early to begin a study-level sourcing strategy and
vendor identification.
SLAs should be defined for vendors with whom your organization works
frequently.

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