Database Closure.

Journal of the Society for Clinical

Data Management. 2023; 1(1): 7, pp. 1–8. DOI:
[Link]

REVIEW ARTICLE

Data Entry Processes

Established procedures for data receipt and entry are necessary for a study to successfully produce
a clinical database of sufficient quality to support or refute study hypotheses. This chapter discusses
considerations needed to reduce the likelihood of errors occurring during data entry processes and ensure
consistency in a clinical database. These considerations cover topics including workflow components, data
receipt and tracking, data entry, data review, data cleaning, and change control for case report forms,
databases, and processes.

Keywords: Clinical Data Management; Data Collection; Data Handling; Good Clinical Practice

Introduction Although some of the specific topics addressed by

The purpose of data entry processes is to ensure data are this chapter may not be the direct responsibility of data
reliable, complete, accurate, of high quality, and suitable management personnel, data managers must have an
for statistical analyses. Data entry processes encompass ongoing awareness of requirements and ensure these
the efficient receipt, tracking, entering, cleaning, coding, tasks have been completed in accordance with the
reconciling and transferring of data. A number of factors principles and standards of their organization, regulatory
should be considered when choosing a data entry process, bodies, and good clinical practice.
such as the skill level and training of personnel, and the
amount of time allocated for data entry. Clinical studies Minimum Standards
vary in study designs and operational plans, therefore • Utilize written procedures describing data flow, data
the specific design and plan should address the unique entry, data processing, and required quality level. En-
requirements for a given study. Throughout a study, an sure enough specificity to reproduce the analysis da-
effective plan will ensure each component or step of data tabase from source documentation.
entry processes provides an appropriate level of data quality. • Ensure employees are appropriately trained (includ-
The International Conference on Harmonisation’s Guidance ing ICH-specified documentation of having been
for Industry: E6 Good Clinical Practice states, “Quality control trained) on systems, procedures, guidelines, working
should be applied to each stage of data handling to ensure practices, and appropriate references (e.g., materials
that all data are reliable and have been processed correctly.”1 such as medical dictionaries, medical abbreviations,
With electronic data capture (EDC) systems, traditional etc.) and that these documents are current and availa-
data management roles may change. In most cases, site ble to employees throughout the course of the study.2
personnel conduct data entry and may have the capability • Ensure all personnel involved with data entry or data
to run edit checks and make data updates to resolve management have the proper levels of access, grants
discrepancies. When data managers are not able to make and privileges.
data edits, they may need to remotely guide site personnel • Maintain a list of individuals who are authorized to
through data cleaning processes. These processes may take make data changes.3
the form of automated checks built into the computer • Apply quality control to each stage of data entry pro-
system, or may operate through queries entered into cesses to ensure data are reliable and processed cor-
the clinical data management system (CDMS). Whether rectly.
a study is EDC- or paper-based, the functionality of the
tools, the design of the study and the skill sets of staff Best Practices
should be carefully considered. • Address the purpose, characteristics and complexity
of each study in data entry training sessions, includ-
Scope ing, but not limited to a brief review of the protocol,
This chapter focuses on data management functions of scope of work, and identification of critical variables
data entry processes, including data receipt, data tracking, (usually privacy controlled subject identifiers, pri-
data entry, change control, data review, data cleaning, and mary and secondary efficacy variables, and safety
discrepancy identification, resolution, and reconciliation. information).
The chapter is not intended to discuss audit or inspection • Verify in a test environment (before the data entry
processes in detail. system is placed into active use) that entry fields func-
Art. 7, page 2 of 8 Data Entry Processes

tion as planned (e.g., date fields only accept dates, Standard operating procedures should be in place to
drop-down lists contain appropriate values, skip pat- ensure blinding of subject identifying information (e.g.,
terns function properly). In some organizations, true name, address, or subject initials) submitted to the data
test data pages may be entered for an entire case center, unless collection of these data is authorized in
report form (CRF) packet, while other organizations the informed consent, protocol, and local regulations.
may perform more focused testing. This is not to be Ensure a process is in place to quickly identify and report
considered a substitute for software validation or edit incidences of violations of data privacy conventions and
check testing. laws. Missing CRF reports should be prepared for both
• Provide comprehensive user training on CRF comple- paper-based and EDC studies to facilitate identifying
tion guidelines and data entry instructions. forms that have not been received.
• Provide sites, sponsors, vendors and study team mem-
bers with timeline expectations for data receipt, data • Electronic data tracking—Computer-aided page
tracking, data entry, and turnaround times for data checking can have higher integrity and efficiency
queries, file transfers and database deliverables. than manual processes. Regardless of how data
• Establish thorough tracking mechanisms for the re- are received, procedures should facilitate timely,
ceipt of CRFs and other forms containing data to be high-quality data processing. Expected visit date re-
entered. Tracking ensures control of the received re- ports can be programmed into most reporting and
cords, identifies missing records and facilitates the tracking systems to follow a subject’s progression
archival of records at the end of the study. through a study and predict the last subject’s final
• Establish database quality criteria, including a quality visit dates.
control plan that appropriately addresses primary ef- • Paper CRF tracking—Tracking may occur on an in-
ficacy and safety data. dividual CRF basis or per module. Ideally, all CRFs
• Monitor data entry functions while in active use to should be tracked, including mandatory, optional,
identify trends and ensure stable and desirable qual- and in some cases ancillary data. Data recorded on
ity levels are consistent with study needs. paper forms are recorded in one of the two following
• Create and maintain comprehensive processes for fashions, although details may vary between organi-
change control. zations. Some organizations may use a combination
of independent or dependent logging with CRF imag-
Workflow ing and indexing.
Although specific processes and steps may vary between   Independent logging—This approach involves
studies and organizations, the flow of data should follow personnel manually registering that study data
a logically prescribed path. When data are received, it (not limited to CRFs) have been received. Data
should first be tracked or logged, then entered, cleaned, receipt may be recorded in the CDMS, although
and subjected to rigorous audit/inspection or quality other tracking systems may be used as well.
control.   Dependent logging—This approach automati-
The general workflow of data entry processes for studies cally records that a CRF has been received when
using paper CRFs is presented in Figure 1, as well as data from the CRF are entered. This approach can
the choices available at each step. To determine which eliminate an extensive and expensive manual
choices are made at each stage in the data workflow, every process, replacing it with an electronic process in
organization should have standard operating procedures which tracking is a cost-free result of data entry.
(SOPs) and data processing conventions. The trade-off is that any steps between receipt
Workflow processes for EDC studies may vary according and entry may result in receipt dates that are not
to the CDMS software used. For general principles of EDC accurate. For reliable receipt dates, data should
workflow processes, see the GCDMP chapters entitled be entered when received, with little or no back-
“Electronic Data Capture—Concepts and Study Start-up,” log of data to be entered.
“Electronic Data Capture—Study Conduct,” and “Electronic • Tracking third-party data—Third-party data, such as
Data Capture—Study Closeout.” laboratory data, may be received electronically or on
paper forms. Documented procedures should be in
Data Receipt place to track data from each external data provider
Data receipt processes vary across the clinical research within a study. For more information about process-
industry. Data may be received through fax transmissions, ing third-party data, see the GCDMP chapter entitled
regular mail, express delivery companies with tracking “External Data Transfers.”
ability, private couriers, hand delivery by monitors, • Imaging and Indexing CRFs—To provide added security
Web entry, or transferred through other electronic and flexibility for paper-based studies, CRFs may be im-
means. Regardless of the data acquisition mechanism, aged and stored electronically in addition to storing the
the processes by which data are received, confirmed as paper forms. CRFs should be scanned using well- estab-
received, and made available for data entry should be lished formats, such as PDF (portable document format).
documented in the data management plan (DMP) in The electronic files must be secured so they are only ac-
sufficient detail to ensure the origin of data is clear. cessible to authorized and trained personnel. File-nam-
Data Entry Processes Art. 7, page 3 of 8

ing conventions should be strictly followed, and the re- • Double data entry (blind verification)—Two people
pository of CRF image files should be indexed to allow independently enter the same data, but remain una-
specific files to be located quickly and accurately. ware of what values the other entered. If the second
entry operator enters a value that differs from the first
Data Entry value entered, the operator is warned that there is a
Data entry processes should address data quality needs of discrepancy. After this warning, the second entry op-
the study. The following are some commonly used data erator (who is responsible for verification) must care-
entry strategies for studies using paper CRFs. fully examine the form and determine the appropri-
ate entry before saving. With this data entry strategy,
Methodologies the second entry will overwrite the prior value if it
• Double data entry (third-person adjudication)—Two differs.
people independently enter the same data and a third • Double data entry (interactive verification)—Two peo-
person independently resolves any discrepancies be- ple independently enter the same data and the sec-
tween first and second entry. ond entry operator resolves discrepancies between

Figure 1: Paper CRF Data Processing Workflow.

Art. 7, page 4 of 8 Data Entry Processes

first and second entry while being aware of the values data integrity. If the system does not allow for this data
entered by the first entry operator. correction technique, a documented method to correct
• Single data entry with a review—One person enters erroneously keyed information should exist.
the data and a second person reviews the data entered Entry screens should be designed to minimize data
against the source data. entry errors. For paper studies, data entry screens should
• Single data entry with no review—Although not rec- follow the pages of the CRFs, and may even be designed
ommended, situations may occur where one person to appear identical to the paper CRFs. Some strategies for
enters data and the data are not subsequently re- minimizing entry errors include displaying coded values
viewed. and providing entry conventions (on entry screens or as
• Optical character recognition (OCR)—Software pack- a separate paper document), labeling entry fields clearly,
ages are used to recognize characters from paper and ensuring entry screens provide sufficient space to
forms or faxed images and these data are placed di- enter and view expected data.
rectly into the database. Data obtained through OCR
should always be reviewed for accuracy. Considerations for EDC
For studies using EDC, sites should be contacted if they are
General Considerations falling behind in data entry. Although sites are typically
Although specific data entry processes are not mandated entering and cleaning data, data management actions are
by regulatory bodies or suggested by FDA and ICH guidance still needed to help ensure data are entered and processed
documents, a data handling document would most likely properly. These data management actions can include
be a desired document in an audit or inspection. Having training site personnel on EDC system use, measuring
a set of standard data entry conventions for entry is site progress on data entry and cleaning, working through
encouraged to ensure consistency in the entry of data forms and data discrepancies with sites, data review,
throughout the study. Data entry processes should be assessing aggregate data to identify subjects with outlying
adapted according to the needed quality level for each data, identifying data trends, verifying any and all coding,
data field. Double data entry is typically used when conducting data transfers and performing reconciliation.
frequent random keystroke errors may occur or if random Regardless of where data are entered, data entry
errors would be likely to significantly impact analyses. personnel should be trained on the specific EDC system
However, a single-entry process with good manual review utilized in a study, as well as being taught the protocol
may be optimal in some circumstances, such as with free and key data issues they might encounter. After data are
text fields. entered, monitors verify data using source documents.
Sites should have clear guidelines regarding timing In some systems, check boxes or particular fields on the
expectations between a subject’s visit and data being entry screen are used by monitors to indicate which fields
entered into an EDC system or recorded onto a paper and visits were verified. In other systems, electronic forms
CRF and forwarded to data management. The data may “graduate” through stages of, for example, data entry,
management team is often responsible for producing monitored (or source document verified), and locked. In
reports that monitor compliance with established data many systems, source document verification is negated
entry timelines. if data are changed on the page. In such a case, source
Although some clinical data management systems are document verification must be repeated.
capable of storing automatic default values, which are EDC systems may include user interface elements such
those written to the database with no action required by as radio buttons and pick lists, and may allow fields to
the entry operator (most frequently, but not limited to, only accept specific variable types, such as only allowing
subject identifiers, site numbers, and visit identifiers), this numeric variables where appropriate. These systems
type of functionality should be used sparingly to reduce may also be designed to allow numeric values to be
the likelihood of unexpected values being overlooked by checked against predetermined ranges upon entry. EDC
data entry personnel.4 In contrast, values that are derived, systems can be designed to have dependencies for fields
converted, calculated, or hard-coded based on the value that should only have data when other criteria are met.
of an entered field do not constitute automatic default An example of this design would be asking if a subject
values and are acceptable processes. Some organizations is of childbearing potential only if female gender had
may perform these calculations outside the database, been selected.
typically by those performing statistical analyses. The growing use of EDC systems has also had an impact
When applicable, system parameters should be set to on the training and desired skills for data entry personnel.
allow an entry operator to exit the entry screen without In a traditional data entry method such as double data
saving the data that has been entered, as opposed to the entry of paper CRFs, the skill emphasis is on the number
system automatically saving entered data upon exiting. of keystrokes made and the training emphasis is on the
In this type of system, there should always be a prompt specific data entry system utilized. With EDC systems
reminding the operator that data has not been saved. utilizing single entry, an overall understanding of the study
This approach enables data entry personnel to correct, becomes much more important in avoiding data entry
upon discovery, situations where data may have been errors. While performing data entry in an EDC system,
erroneously entered. Requiring a conscious decision site personnel may need to check for online queries and
to save data can also contribute to a higher level of recognize discrepancies as they enter data.
Data Entry Processes Art. 7, page 5 of 8

Data Entry Guidelines • Search for invalid date values and invalid date se-
Whether using paper CRFs or an EDC system, detailed quences.
data entry guidelines should be provided to all data entry • Verify that complex multifile (or cross-panel) rules
personnel. All data entry personnel should also provide have been followed. For example, if an adverse event
written documentation that they have received and of a particular type occurs, other data might be ex-
understood these guidelines. Data entry guidelines may pected, such as concomitant medications or proce-
be part of a broader user manual, particularly for studies dures.
using EDC systems. Both data entry guidelines and user • Check for any investigator comments entered on the
manuals may take the form of paper documents or an CRF that could explain data anomalies.
online manual. • Reconcile all expected CRFs received with those that
The following topics should be considered for inclusion have been entered.
in data entry guidelines or user manuals. • Confirm inclusion of guidelines detailing reconcili-
ation of adverse events, serious adverse events, lab
• Contact information of individuals available to trou- data, or any additional third-party data.
bleshoot computer problems and the hours such help • Check consistency of data across CRFs.
is available • Confirm that data are logical, even when outside ex-
• Instructions or conventions describing how to enter pected parameters.
data, delete data, and respond to queries
• Instructions or conventions describing how to enter Range checks should be designed to identify statistical
data for single and multiple record panels if there is a outliers, which are values that are physiologically
difference in the system impossible or outside normal variations of the population
• Reminders to users that a date/time stamp and a user under study. Consistency checks should be designed to
name are recorded as part of the audit trail for every identify potential data errors (e.g., checking the sequential
record. The audit trail may or may not be visible, de- order of dates, corresponding events, and missing data
pending on the computer system. Even if it is not vis- noted to exist elsewhere). Checks designed to identify
ible during data entry, the audit trail must be readable protocol violations should be closely monitored to allow
by inspectors and auditors. timely action to be taken. A site should be monitored and
• Information on computer system security investigated when aggregate statistics or other checks
• Instructions for proper computer shutdown proce- indicate substantial differences from other sites. Although
dures to prevent loss of data manual review for data cleaning and validation is sufficient
• Instructions for data entry personnel explaining ap- in some cases, programmatic validation provides high
propriate actions when edit checks trigger or reconcil- consistency and lower error rates.
iation windows for double data entry systems appear Primary and other endpoints, key safety parameters
and fields that uniquely identify subject data within the
Data Review clinical database should be validated sufficiently to assure
Data Cleaning data are possible, complete, and reasonable. Data cleaning
Data cleaning refers to a collection of activities used to and validation procedures should not suggest bias or lead
assure the completeness, validity and accuracy of data. responses, because leading questions or forced responses
Data cleaning activities may include manual reviews of can bias study results.
data; computer checks that identify inaccurate or invalid
data using ranges, missing data, protocol violations and Data Cleaning Considerations for EDC
consistency checks; or aggregate descriptive statistics Many of the data cleaning activities in the preceding list
that reveal unusual patterns in data. Early in a study, can be automated within a well-designed EDC system
data should be reviewed from several subjects at each and may not require any post-entry effort. In an EDC
site to help detect problems with data entry screens not environment, the site typically performs much of the data
functioning as expected or a site’s lack of compliance or cleaning at the point of entry. The site is in control of the
understanding of the protocol. data and must either make the data edit or clarify the
The following list describes activities that may be reason the data are acceptable. For a comparison of data
included in data cleaning.4 cleaning processes between studies using paper CRFs or
EDC systems, see Table 1.
• Verify raw data were accurately entered into a com- The number of characters an EDC system will allow in
puter-readable file. a query is important for the data manager to know. Some
• Confirm code lists contain only valid values. data managers may be accustomed to paper queries with
• Confirm numeric values are within predetermined unlimited space, but most EDC systems require a scroll
ranges. bar to view lengthy queries. This increases the importance
• Identify and eliminate duplicate data entries. of writing succinct queries to instruct the site to correct
• Determine if there are missing values where complete data or explain the reason for a discrepant or “abnormal”
data are required. data value.
• Check the uniqueness of certain values, such as sub- In an EDC system, built-in checks may initiate either
ject identification numbers or codes. at the time of data entry or when edit checks are run on
Art. 7, page 6 of 8 Data Entry Processes

Table 1: Data Cleaning Distinctions Between Paper and EDC.

Data Cleaning Activity Paper-based EDC

Discrepancies, Flags or After entry and review are complete, flags or For data entry systems withno additional
Notes notes may be generated outside the database and functions, flags or notes are identifiedby
submittedon individual data clarification forms monitors and treated similarly to paper.
(DCFs).
Some systems show flags ornotes on the screen
Flags or notes may be compiled during entry and in real time, allowing sites to address flags or
review, and subsequently addressed after data notes sooner.
entry iscompleted.
Some systems close flags ornotes automatically
In some instances, items may also be flagged or as values are updated, while others may require
noted during monitoring. manual closing by monitors or data management
personnel.
Listings Cleaning listings differs from cleaning Some systems allow cross- page checks, but these
discrepancies, flags and notes in that cleaning may be limited in scope as manyprogrammatic
may not occur as often due to a higher level text checks must be manually reviewed.
of review by monitors, coders, statisticians, lab
When posting responses or feedback, some
reconcilers,or safety managers.
systems may update or populate items right
Listing reports may be sent to sites periodically away, but othersmay be delayed due to system
to pointout missing pages or overdue visits. uploads occurring atpredetermined intervals.

batches of data. Additional edit checks may also be run record of any data change should be provided to the site.
and reviewed prior to issuing queries. All documentation of data changes is considered to be
To ease review and possible correction by site personnel, essential study documentation and is subject to audit or
data managers should understand the EDC system inspection. For comparison of differences in data-change
and how data checks are attached to data fields. When documentation between paper-based studies and studies
checks are not issued against the correct panel, sites may using EDC, see Table 2.
be confused and not take appropriate actions. If a data Data cleaning conventions may, under some
check is to initiate automatically, it should check each circumstances, specify data that can be modified without a
data field only once. To prevent duplication of effort, site’s acknowledgement. These are known as self- evident
data management personnel should review previously corrections (SEC), and examples include appropriately
issued data checks. Because sites must respond to data qualified personnel correcting obvious spelling errors,
queries prior to any in- house review, it is critical that converting values when units are provided, or providing
checks be properly tested prior to deployment. Deploying missing identifiers when the true values are obvious.
inadequately tested checks may result in unnecessary Because the site must have a record of all data changes,
work for the sites and data management team. the site should receive and maintain a copy of each version
Because sites may change data for various reasons, some of such data conventions.
users of EDC systems may not realize data that is clean Although strongly discouraged, situations do
today may not be clean tomorrow. These data changes occasionally arise where telephone conversations with
may not be the result of data queries but rather a review the site are utilized to authorize data changes. If this does
of source data. Some systems are capable of locking data occur, these changes should be clearly documented both
once it is clean, however a mechanism should allow by the site representative authorizing the change and by
the lock to be reversed for data changes if the site finds the data center representative talking with the site. In
discrepancies that must be corrected. this way, a record of the conversation and authorization
exists at both locations. In any case, any data change
Documenting Data Changes authorizations must be documented in writing and
Data may be changed as a result of data cleaning included in the study’s documentation for audit or
procedures, in which case the site and data center or inspection purposes.
sponsor must retain a record of all such data changes. An audit trail is triggered by the initial data entry, and
Data changes should be recorded and documented by a any changes to the entry are captured and should include
fax or original site signature acknowledging the new data. the user name, the date and time of the change, the
This documentation is usually accomplished using a query reason for the change, and the previous and current value.
or data clarification form (DCF). In these cases, the site is Recorded changes must not obscure previously recorded
expected to keep a record of the change within their study information.5 To obtain consistent, accurate reasons for
records. changes, some EDC systems offer a list of reasons for data
In an EDC environment, site personnel usually make any changes as well as an option for free text. Since these
necessary changes to the data. If nonsite personnel make reasons may vary, there should not be a default entry.
data changes, a clearly defined SOP should document Once a change has been committed and recorded in the
circumstances in which data can be changed, and a audit trail, the reason cannot be edited.
Data Entry Processes Art. 7, page 7 of 8

Table 2: Data-change Documentation Distinctions Between Paper and EDC.

Data Change Type Paper-based EDC

Entry changes or System or process changes should be reflected in When changing data, the EDC system should
errors data entry work instructions. prompt the user to enter a reason for the data
Database changes must be reflected in the audit change. The reason provided will then be recorded
trail. in the database’s electronic audit trail.
When authorized changes are submitted by e-mail For non-site personnel, data entry work
or phone, a hard copy should be created for patient instructions or conventions will be used for
folders both at the site and with data management. documentation.
Data Clarification A hard copy of system- generated DCF submittals, Rather than using paper DCFs, queries are
Form (DCF) updates once approved by authorized site personnel, generated and answered through the EDC system,
should be kept with corresponding CRF pages at which should include a comprehensive history of
site(s) and with data management. all queries recorded in the electronic audit trail.
Self-evident Self-evident corrections should be documented Self-evident corrections should be noted in the
corrections in study-specific conventions and data entry work electronic audit trail.
instructions.
Site-initiated changes Site-initiated changes should be documented Site-initiated changes should be noted in the
through manual DCF submitted with or without electronic audit trail as new information provided
an updated CRF page. by the site.

A site’s principal investigator should approve and sign Any process changes that involve investigative sites
off on data collected from that site prior to the data being should come with clear communication and associated
finalized. This sign-off by the principal investigator must training (if training is deemed necessary). The clinical
occur in both paper- and EDC-based studies. Any data monitoring team should also be involved in process
changes that occur after the investigator signs must be changes involving investigative sites. Process changes
re-signed by the investigator prior to study closeout. not involving site or monitoring staff should also include
proper documentation, communication and training.
Change Control Process changes should not be implemented until
Protocol amendments are a fact of life in clinical studies. approval is received from all stakeholders and the change
Changes to the protocol may be made when new is thoroughly tested and validated. In some cases, changes
information becomes available or is requested by the may also require IRB approval.
sponsor or regulatory agencies. While not all protocol
amendments require CRF changes, procedures should be Database or CRF Change Control
in place to handle these situations. IRB approval of protocol If an approved change is made to an existing CRF or a
amendments must be received prior to deployment of new new CRF is created as a result of a protocol amendment,
or changed CRFs. With paper-based studies, CRF changes data management is responsible for checking the
may take a few weeks to be received by sites, by which time consequences on the CRF completion rules and data
the sites may have received IRB approval for the protocol entry guidelines, and if necessary, is responsible for
changes. However, with EDC systems CRF changes can be modifying any existing database tables and creating any
made remotely and implemented immediately upon IRB new database tables. Documentation of all changes and
approval of the protocol changes. necessary validation testing is also the responsibility of
appropriate data management personnel. As with process
Process Change Control change controls, any changes should be communicated
All process changes initiated from a protocol amendment to the investigative sites in a timely manner. If CRF
must be requested, reviewed, validated, approved and completion guidelines or data entry guidelines change as
incorporated by following the organization’s SOPs. If a result, ensure all changes are reflected and disseminated
a process change involves modification of the clinical to appropriate personnel.
database, strict change control processes should be used
to ensure preservation of clinical database integrity. Change Control for External Data
Documentation of all process changes should always be External data can originate from different sources, and are
stored and available for the entire project team. usually provided by previously selected vendors. External
At minimum, a process change should include data include any data that are received as an electronic
identification and acknowledgement of the change, file rather than through paper- or EDC-based data
communication of the change to all entry. Any changes to external data should be corrected
stakeholders, and a detailed request outlining any or updated at the source if possible. The vendor and
necessary modifications. The process change should data management should establish specifications and
be reviewed and approved by key stakeholders prior to procedures at study start-up to describe how data changes
implementation of the change. will be communicated throughout the study.
Art. 7, page 8 of 8 Data Entry Processes

Changes may be communicated between the site References

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Clinical Practice, E6, Section 5.5.3.e. Geneva,
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• Data Review
• External Data Transfers Chapter Revision History
• Discrepancy Management Publication Date Comments
• Quality Control September 2000 Initial publication.
• Database Lock Procedures January 2002 Content revised.
• CRF Archival May 2007 Revised for style, grammar, and clarity.
Substance of chapter content unchanged.
Competing Interests October 2009 Revised for content, style, grammar, and
The author has no competing interests to declare. clarity.

How to cite this article: Database Closure. Journal of the Society for Clinical Data Management. 2023; 1(1): 7, pp. 1–8. DOI:
[Link]

Submitted: 01 Decmeber 2023 Accepted: 01 Decmeber 2023 Published: 22 December 2023

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