Clean file can be declared when all required data management activities have been completed as per the data management plan. This includes final reconciliation of external vendor data, completion of coding and discrepancy management activities, and signing off of all CRFs by the principal investigator. The data management team's role in clean file includes performing manual reviews, ensuring reconciliation of safety databases, and communicating any issues to monitors during the clean file declaration process.

1. Clean File/Form Lock
1 11/20/2017Katalyst Healthcares & Life Sciences

2. Icons Used
Questions
Demonstration
Hands on
Exercise
Coding
Standards
A Welcome
Break
Tools
2
ReferenceTest Your
Understandin
g
Contacts

3. OBJECTIVES
3
After completing this module you will be able to understand:
➢ What is Clean File?
➢ Procedures required for Clean File
➢ Clean File Checklist and Form
➢ How to declare Clean File
➢ Dos & Don'ts
➢ Importance of Clean file
➢ DM Role in Clean File
➢ Steps to Declare Clean File
Objectives

4. WHAT IS CLEAN FILE?
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➢ Clean File means that the data recorded in clinical trial is clean & ready for Database Lock/freeze
➢ Clean File can be declared for a study when all required data management activities (as per the
Data Management Plan) have been completed and documented appropriately
➢ This is the last step prior to database Lock/Freeze usually done once all trial data is
received/recorded and data discrepancy is addressed/resolved.
➢ Clean File ensures
• Data is complete i.e., No missing data
• Data is consistent
• Data is accurate
• Data is reliable
• Data is discrepant free

5. PROCEDURES OF CLEAN FILE
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There are various procedures that are followed for declaring Clean File on the data provided
These procedures are as follows:
➢ Manual review :
• Listings
• Reports
• Trackers
➢ Final reconciliation of external vendor (Third Party) data
For e.g.. Lab data, Pharmacokinetic data, Pharmaco-genetic data, etc)
➢ Final reconciliation of AE, SAE & Concomitant medications
➢ Completion of Coding activity
➢ Completion of Discrepancy Management activity
➢ Completion of Source data verification
➢ All CRFs have been approved & signed by the Principle Investigator

6. ACHIEVING CLEAN FILE:
THIRD PARTY VENDOR DATA
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➢ Check data query turnaround timelines (with Third Party Vendor) and ensure
process for quick turnaround are in place
➢ Validate test transfers thoroughly before getting production data transfers to
ensure transfers are as per the specification provided to Third Party Vendors (e.g.
of TPV data are safety laboratory data, ECGs, PK, PD, etc.)
➢ Agree and Document:
• Variables, Method, format and frequency of data transfer from the provider to
Data Monitoring Committee in a Data Transfer Specification
• Confirmatory mail is required from the TPV for the final transfer of TPV data
• Allow enough time for data validation

7. ACHIEVING CLEAN FILE: SAE
RECONCILIATION
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1. Perform Final SAE
Reconciliation for the
study from FSI date
2. Check for
outstanding issues if
any i.e. either from
clinical database or
from safety database
and resolve it
3. Check for
accepted
discrepancies
4. Ensure that final
SAE Reconciliation
is completed for the
study
5. Sign the Final SAE
Reconciliation form
for archival in Study
Master File

8. ACHIEVING CLEAN FILE: SAE
RECONCILIATION
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➢ Examples of acceptable discrepancies that can remain after SAE reconciliation:
• SAEs entered in Safety database after data cut off date but missing in the
study database
• Post-study SAEs are entered in the study database which are not required
• An outcome is provided on the Safety database for SAEs resolved outside the
follow-up period
• Coding Mismatch due to medical equivalence (not exact match) of coding
exist in the Safety database and the clinical database.
➢ During SAE reconciliation if an SAE is found missing in the Safety database or if
the severity of an existing SAE changes to fatal or life threatening,then DM is
responsible for reporting this urgently (latest by the end of the next business day)
to the Safety Team Personnel.

9. ACHIEVING CLEAN FILE :
CODING
1. Coders should ensure
that there are no terms
with missing dictionary
codes in the SAS
datasets/study database.
2. Consistency report is
generated by the
Coder/DM
3.The consistency report
is reviewed by the Sr.
Coder and then sent to
the study physician by the
Coder/DM
4.The Study Physician
reviews and provides
suggestions for
recoding or querying
5 The report reviewed
by the Study
Physician is sent back
to the Coder/DM
6. Coder executes
the changes as
per the
suggestions from
the Study
Physician

10. ACHIEVING CLEAN FILE:
DATA VALIDATION QUERIES
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• Central Study Delivery Team and Data Monitoring Committee can decide to use
either an email (to be used only if secure) or fax query process at clean file. This
process should be decided well in advance before LSLV
• Ensure communication strategy is in place so that queries are not overlooked by
site staff or monitors
• This is critical during final validation otherwise timelines may be jeopardized
• Ensure clean patient tracker is filled to track the status

11. • The Clean File Checklist facilitates timely submission of an error free Clean File
• Clean File Checklist & Form helps in :
– Verifying all that is required is in place
– Assuring that nothing has been missed out
CLEAN FILE CHECKLIST & FORM
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Clean File

12. CLEAN FILE FORM
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Document the CF
decision on ‘Clean File
Form’ provided by
Client/Sponsor
‘Final or interim’
should be ticked as
per the study
specifications by
Client/Sponsor
Tick ALL boxes
and add a
comment where
needed

13. CLEAN FILE FORM
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Clean File declared date : ------------------------
(DD/MM/YYYY)
Endorsed by : ----------------------- -----------------------
Study Team leader/Client signature Team Manager / DMTL’s
signature
Sign and date from SDL and
DMTL’s/Team Manger
After completion archive
Clean File Form in the
Study Master File with
associated documents to
support decisions on the
data

14. • A Clean File meeting is held with relevant Study Delivery Team members
• Relevant team ensures that all activities required to declare Clean File as specified in the
Clean File Form/other procedures are reviewed
• Clean File decision is taken for all study data
• Data Monitoring Committee Representative documents the clean file decision and any
critical exceptions on the ’Clean File Form’template
• Relevant team ensures that written minutes from this meeting are taken
• The Clean File Form is signed and archived in the SMF(Study master file)
DECLARING CLEAN FILE
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15. The following factors decide Database lock:
• Clean file has been declared for the study
• All treatment-revealing data have been transferred
• All post transfer consistency checks have been completed successfully
• No more additions or other changes to the database are anticipated so the database can be
locked & the study can be unblinded.
POST DECLARING CLEAN FILE :
DATABASE LOCK
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16. • SDT/ LDM/ DMTL ensures that access to the study database is removed or restricted,as
applicable
• Updates the Database Access List
• Ensure that study access is revoked from all the data managers (except LDM and one DM)
• Access Restriction can be done prior to Clean File lock
POST DECLARING CLEAN FILE:
DATABASE ACCESS
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17. Post Clean File data errors and documentation:
Database Lock
POST CLEAN FILE DATA ERRORS
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Client/Spons
or decision
Error
Considere
d Critical
Document
Non-Critical
Error form
Document
Critical
Error form
Query
neede
d
Unlock database
Raise query
Resolve query
Re-extract data
Review data
errors
Update
Database
Access List
Correct Error
No
Ye
s
Re-lock
Complete the necessary steps as
per the Sponsor/Client
specifications
No
Ye
s

18. Do’s
• Discrepancy management activity is performed regularly
• Manual review performed regularly
• Preparing & sharing Clean File plan during study setup with all study team members
• Adhering to the Clean File plan
• Inform QA/QC team at least 2 months prior to Clean File date
• Proactive communication with the Monitors/Point of Contact for any issues or delays in the study timelines as
and when required
• Get the Monitoring plan from the Monitors and plan accordingly
• Timely documentation of each and every activity
• Everyone doing their share of work on time
DO’S
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19. Don'ts
• Do not keep Pending /Outstanding issues
• Do not accept any changes in the database without proper reason for the change
• Do not keep a practice of using Note to File/File Note
• Do not get scared of escalating issues to the relevant team
DON'TS
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20. Helps in timely submission of data for the generation of results, analysis and submissions
IMPORTANCE OF CLEAN FILE
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21. • Clean File can be declared for a study when all required data management activities (as
per the DMP) have been completed and documented appropriately
Data clean activity in a nut shell:
• All data have been received and processed
• All queries have been resolved
• External data (e.g., electronic laboratory data) are complete and reconciled with the study
database
• If a separate database exists for adverse event database, it is reconciled with the main study
database
• The coding list has been reviewed for completeness and consistency
• Final review of logic and consistency check output has taken place
• Final review for obvious anomalies has taken place
• A quality audit of the data and the corresponding documentation of the error rate have both
occurred
• All documentation is updated and stored according to standard operation procedures
• In case of the issues observed during clean file declaration (Like missing pages/missing PI
Signatures) communicate with the Monitors/Point of Contact & relevant teams
DM ROLE IN CLEAN FILE
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22. QUESTIONS
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23. In God we trust!
Everyone else must show us the data!
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24. • What is Clean file?
• When can you declare Clean file?
• DM role in Clean file?
TEST YOUR UNDERSTANDING
24

25. • Clean File means that the data generated from clinical trial is clean & ready for Database Locking/freezing
• Clean File can be declared for a study when all required data management activities (as per the Data Management Plan)
have been completed and documented appropriately
• These procedures are as follows:
➢ Manual review in the form of Listings, Reports,Trackers
➢ Final reconciliation of external vendor (Third Party) data
For e.g.. Lab data,Pharmacokinetic data, Pharmacogenetic data,etc.)
➢ Final reconciliation of AE, SAE & Concomitant medications
➢ Completion of Coding activity
➢ Completion of Discrepancy Management activity
➢ Completion of Source data verification
➢ All CRFs have been approved & signed by the Principle Investigator
• In case of the issues observed during clean file declaration (Like missing pages/missing PI Signatures) communicate
with the Monitors/Point of Contact & relevant teams
SUMMARY
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26. – You have successfully completed - Clean File/Form Lock
ThankYou
&
Questions
11/20/2017
Contact:
Katalyst Healthcare’s & Life Sciences
South Plainfield,NJ,USA 07080.
E-Mail:info@KatalystHLS.com