Chapter 26: Study Closeout

Chapter 26: Study Closeout

As a protocol finishes data collection and comes to a close, steps must be taken to ensure
that the data are complete and accurate. This process requires a lot of communication
between the sites and the Data Coordinating Center (DCC) to clarify outstanding issues
and finalize the study database.
A. Purpose
To establish procedures to ensure that the data collected during the protocol is compiled,
finalized, and locked at the end of the protocol in a consistent manner across study sites.
B. Personnel
Study Coordinator
Principal Investigator
Data Manager
Technical Director
Project Manager
Biostatistician
C. Protocol Closeout
During this phase of the study, the DCC actively queries the data and the sites to resolve
anomalies and oddities identified in the database. This may include posting of data
queries, posting of study queries, or other means of communication regarding the
anomalies. Only once all data queries have been resolved or adequately explained, can
the database be considered final.
C.1 Cleaning and Querying Phase
Data cleaning will begin prior to the end of the study. Once data collection is completed
at a given site, the DCC will begin the final cleaning and querying process for that site.
At this time, the site Study Coordinator should also begin to review and complete the
items listed on the Site Study Closeout Checklist (Appendix A).
The final cleaning process can take up to three months to complete (refer to the DCC
Data Cleaning timeline in Appendix B for more timeline information). During this threemonth period, the DCC will review the sites study data to identify anomalies and
oddities. This may include writing new data queries on the back-end, writing new reports
or working with the study Biostatistician to calculate new variables.
The DCC will communicate all queries to the sites through the DEMS or X-ACT study
website. All resolutions and responses to the queries should be documented as instructed
by the DCC.
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C.2 Closeout Site Visits

After a site has completed their last study visit, but prior to finalizing the data for the site,
DCC staff will make their final visit to the site. During this visit, the DCC monitors will
review the paper research and consent charts and study documentation. A study closeout
visit agenda is included as Appendix C.
The DCC will post the final site visit monitoring report within two weeks of the visit.
The site must review and respond to all issues identified within one month of the report
posting date. All reports and responses will be posted to the X-ACT study website.
Refer to XACT MOP Chapter 14: Quality Assurance for additional information on site
visits.
C.3 Mint Destruction
After all study visits are completed, the Study Coordinator should complete the mint
destruction process. All mints must be destroyed according to study-wide and sitespecific procedures. The study-wide mint destruction procedure is detailed in Chapter 25
of the X-ACT MOP.
D. Database Lock
Database lock occurs once all data points are considered to be finalized, and no further
changes to the database are expected. This usually occurs once all data cleaning is
completed and all anomalies and oddities have been fully documented.
D.1 Completing Site Study Closeout Checklist
The Site Study Closeout Checklist is included as Appendix A of this document.
Beginning during the querying phase of the closeout process, the site Study Coordinator
will begin to complete this checklist. The checklist must be finalized prior to database
lock. Each item listed on the checklist must be checked as either Complete or Not
Applicable (N/A). All N/A responses must be explained in the notes section. In
addition, the notes section should be used to explain any anomalies or oddities that are
identified during the data cleaning process. The notes section can also be used to
document the location of information relevant to the study (i.e. the location where
research charts will be stored after the study is complete, the dates of mint transfer for
destruction, etc.).
The site should keep the original, signed version of the completed checklist on file. They
must also either upload a copy of the signed checklist to the XACT website (in .pdf
format) or mail a copy of the signed checklist to the DCC for their records. If uploaded to
the website, post the checklist to the Documents/Clinical Sites/your site
name/Closeout folder and send an email to the Data Manager detailing the completion
of the checklist.
The DCC stores the completed and signed Closeout Checklist with all of the other
protocol database documentation and binders.
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D.2 Locking the Database

Once each site has sent a signed copy of the Site Study Closeout Checklist to the DCC,
the DCC will complete the DCC Closeout Checklist (Appendix D). The Data Manager,
DCC PI, and DCC Biostatistician must all sign off on the DCC Closeout Checklist. Once
all sign-offs are complete, the DCC Data Manager will lock the raw database. The final
raw database includes only those data collected on the CRFs and as specified by the data
dictionaries. The database does not include recoded or transformed variables or scales
created using the raw data. Locking does not include data that are changed in some way
based on decisions that are made in the analysis of the data such as omitting subjects,
collapsing variables, truncating distributions, data transformations, and outlier exclusions.
Only once the raw final database has been locked, will the DCC proceed with creating the
final analytic database. The analytic database is the database that is used for the study
analyses. The analytic database contains variables that are derived and/or computed from
the raw data on the CRFs, including subscales and total scores. The analytic database
contains the transformed values of raw variables if data needs to be transformed prior to
analysis; summarized variables (e.g., if a weekly mean is being used in analyses, but
there are 3 measurements per week, then the weekly mean would be in the analytic
database); and imputed variables.
D.3 Database Unlocking
Should the DCC find any database issue that requires the database to be unlocked, the
DCC Data Manager will immediately notify the site PI, DCC PI, DCC Biostatistician and
DCC Technical Director. Conversely, if a site finds any database issue that requires the
database to be unlocked, they should notify the DCC Data Manager immediately. The
DCC Data Manager will specify the database issue and the plan to rectify the database
issue. Once the issue has been resolved, the database will be relocked and the Database
Relock Form will be completed (see Appendix E).

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Appendix A
Site Study Closeout Checklist
To be completed by the Site PI and Study Coordinator

Site:

Protocol:

Marking Complete means that all versions of the following essential documents are present and up-to-date
or items are completed as stated
Marking N/A means that the listed item is Not Applicable for the Protocol (if marked, explain why in the
Notes section)
Complete

N/A

Notes

I CRF/DATA Completeness
A. All data collection is completed through the last
participants last follow-up.
B. All CRFs are complete, including data that
requires transcription from source materials.
C. All study data has been entered into the DEMS.
D. All SAEs have been followed until conclusion or
acceptable resolution.
E. All Oral Examination forms were double key
entered as required by study procedures.

II CRF/DATA Queries
A. All data queries have been resolved or explained
in the dataset (this includes full explanation of all
true data anomalies that cannot be corrected in the
database).
B. All Closeout Site Visit issues have resolved
and/or documented and the final response(s)
posted to the XACT website .

III. Reports
A. Final Trial Monitoring Reports have been stored
with the sites study documentation (either paper
or electronic version).
B. All site visit reports and site responses to reports
are completed and stored with the sites study
documentation (either paper or electronic).
C. Plans have been made for submitting ongoing
IRB submissions until the final IRB report can be
filed.
D. All documentation relating to protocol violations
(from both the site and the DCC) are stored with
the sites study documentation.
E. A list of site specific anomalies that occurred that
may have interfered with normal study flow (e.g.
earthquake, strike).
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Complete

N/A

Notes

IV. Mint Destruction

A. All mints and mint containers have been
destroyed in compliance with study-wide and
site-specific procedures.
B. All completed Mint Destruction Logs have been
sent to the DCC (either uploaded to XACT
website or mailed/faxed).
C. All documents related to Mint Destruction are
stored with the sites study documentation.

V. Document Storage
A. Arrangements for storage of all hard copy study
related documentation have been made.
B. Arrangements for storage of all electronic study
related documentation have been made.

Summary or other Comments:

The sites Principal Investigator confirms the above checklist is complete and the sites files are ready for data
lock-down.
Site PI Name
Site Study Coordinator Name

Signature(s)

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Appendix B
XACT DCC Closeout Time Line
A site collects its last
data point

1 month later

2 months later

3 months later

4+ months later

DCC and site work together to clean the database and resolve all queries

Site works on completing Site Closeout Checklist

Site sends completed Site
Closeout Checklist to DCC
DCC Closeout checklist
completed & DCC locks
the raw database
DCC creates analytic
database

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Appendix C
X-ACT Final Monitoring Site Visit Agenda
1. Meet with Study Coordinator: This is just a brief discussion to get oriented and
determine if the site has any issues or questions that need to be addressed. It is
optional for other staff (PI, examiners, hygienists, data entry staff, etc) to be
present for this first discussion.
o Overview of todays site visit plan
o Discussion of current issues/concerns
Final visits
Study procedures
Staffing concerns
Adverse Events
Drug Accountability and treatment application
2. Review Final Regulatory Documentation
o IRB materials and documentation
o Protocol documentation
o Forms and MOP binders
o Training documentation
3. Review Participant charts
o Review newly collected data for charts that were reviewed at previous
visits
o Finish reviewing all consent charts, if not already complete
4. Review mint accountability records
5. Review supplies
o Storage of supplies
o Final record keeping related to supplies and destruction
6. Debriefing session with PI and Study Coordinator
During the visit: The DCC monitors will want to meet briefly with the Study Coordinator
to go over any current issues or concerns. The majority of the visit will be spent
reviewing the regulatory documentation and both the consent and research charts. The
DCC monitor will need a private area with a table and seating for two monitors. A
debriefing meeting with the Study Coordinator, at a minimum, will be held at the end of
the visit to go over any issues or concerns that the monitor may have.
Following the visit: The DCC monitors will complete a detailed monitoring visit report
within two weeks of the site visit. The report is due within one month of the monitoring
visit. Copies of the monitoring visit report will be distributed via the secure XACT
website. Copies will be made available to relevant site staff, the XACT administrative
chair, the DCC, and the XACT Project Officer. The site PI or designee must respond to
the monitoring report, showing resolution of all issues, within one month of receipt.

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Appendix D
DCC Closeout Checklist
To be completed by DCC Data Manager

Protocol Title:
Study Type:

Behavioral

Medication

Combination

Other

Marking Complete means that all versions of the following essential documents are present and up-to-date or items are completed as
stated
Marking N/A means that the listed item is Not Applicable for the Protocol (if marked, explain why in the Notes section)
Complete

N/A

Notes

I CRF/DATA Completeness
A. All data collection is completed through
the last participants last follow-up.
B. All CRFs are complete, including data
that requires transcription from source
materials.
C. All data has been entered into the DEMS
or sent to the DCC (including any site
data that is analyzed off-site, e.g. urine
data files).
D. All collected data are entered in one or
more data files (including screen fail data
where collected, baseline records, in
treatment records, final visit/tx-end
records, and all follow-up points).
E. All missing records (CRFs) have been
verified as truly missing (e.g. not
collected).
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Complete

N/A

Notes

Missing values with forms (e.g. missing

items on a CRF that is otherwise
complete) have been verified as truly
missing (e.g. not collected).
G. Primary Key fields do not contain any
missing data.
H. All AE/SAE CRFs are complete.
F.

II CRF/DATA Accuracy
A. There are no duplicate records in the data
files.
B. All range checks were performed (as
specified in the Data Dictionaries).
C. All within-form consistency checks
between items were performed (as
specified in the Data Dictionaries).
D. All cross-form consistency checks for
critical and repeated items were
performed (as specified in the Data
Dictionaries).
E. All outside data files (e.g. urinalysis
results files) have been checked for
accuracy and consistency.
III CRF/DATA Queries
A. All queries have been resolved or
explained in the data set.
B. All DCC Closeout visits have been
completed.
IV. Reports
A. Summarized or Aggregated Report of
Participant Recruitment, Progress, and
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Complete
B.

F.
G.

H.
I.
J.

K.

L.

M.
N.

N/A

Notes

Retention.
A list by follow-up point of all
participants that did not complete each
follow-up visit with a reason why (e.g.
Never Showed, In Jail, Asked never to be
contacted again, etc.).
Summarized or Aggregated Report of the
CRF Completeness.
Include a list, by CRF, of all participants
missing the CRF with a reason why (e.g.
Participant Never Showed for
appointment, Participant left early, etc.).
Summarized or Aggregated Report of the
errors triggered during chart review, at
time of entry and nightly.
Summarized or Aggregated Report of the
Data Audit Reports by CRF.
A Report of Protocol Violations This
report would summarize each violation
and describe the process for resolution, if
necessary.
A Summarized Report of any data
anomalies that exist in the clean
database. The report must include
information that would uniquely identify
the record or records affected.
A list of site specific anomalies that
occurred that may have interfered with
normal study flow (e.g. earthquake,
strike).
A report listing the final timelines of data
entry for all forms.
Final adverse events reports to

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Complete

N/A

Notes

summarize serious and non-serious

adverse events.
O. An electronic copy of the CRFs and Data
Dictionaries.
V. Mint Destruction
A. All mints and mint containers have been
destroyed in compliance with study-wide
and site-specific procedures.
B. All completed Mint Destruction Logs
from the sites and DCC are on file at the
DCC.
Summary or other Comments:

The Data Coordinating Center Data Management team confirms the above checklist is complete and the data
files are ready for data lock-down.
DCC PIs Name
DCC Biostatisticians name
Technical Directors
Data Managers Name
Signature(s)

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Appendix E

X-ACT
Database ReLocking Form
Date of

Site

Reason for Unlock

U
n
l
o
c
k

Date of
Relock

Signatures

Site PI:
DCC PI:
DCC Data Manager:
DCC Biostatistician:
Site PI:
DCC PI:
DCC Data Manager:
DCC Biostatistician:
Site PI:
DCC PI:
DCC Data Manager:
DCC Biostatistician::

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