Download Data Management File Note

Data Management File Note
Version 4/21.11.12/JHP
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FILE NOTE
Trial Master File
Section …..
Brief study title:
Chief/Principal Investigator:
R&D ref no:
Hospital address:
Investigator to complete this file note if there is no study-specific Data Management SOP.
Date:
Regarding: Data Management Plan
Database details
Give type, software, size etc (E.g Excel spreadsheet or
more complex system)
Is the database held on the Trust server?
If the database is held externally to the Trust, is there
a third party agreement?
Are there security/access restrictions in place?
If yes, what are these restrictions?
Who has access to the database?
Do users require a username and password?
Will there be an audit trail if any changes made to
data or missing data added? An audit trail is a record of
who did what, when and why and must be kept throughout the
study and during archive of the database. Data changes must be
documented and there must be no deletion of entered data.
Who is authorized to make data changes?
Will there be regular back up of data? How often
and by whom?
Are there disaster recovery plans?
What is the software package to be used for data
analysis?
Where will the database be archived? Duration of
archive is 5 years from study end.
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Data coding
Will data be coded and if so, when and by whom?
Is coding done manually or automatically as data is
entered?
Will AEs be coded? Will there be a coding system
used (e.g MEDRA, WHO-ART)?
Data queries
Who checks the consistency of data?
Who generates data queries?
Is there a data query form?
Are data queries signed and dated when answered
by a study doctor?
Who decides that a data query is resolved?
Data entry
How is data entry done? Single data entry by one person
with control checks e.g. visual check or double-data entry by two
people separately.
Data validation
Are automatic data entry checks done? If yes, what
type of checks are done? E.g. check and alert for values
entered out of specified range, for missing values, for illogical
values, numeric values when they should be text or vice versa.
Checks should be defined before study start.
Data protection
Is patient confidentiality being maintained in the CRF
and database?
How are patients identified in the CRF and database
to respect confidentiality? E.g. study patient initials
and study number only.
Data storage
Are CRFs in paper or electronic form?
Where are CRFs stored during the study? CRFs
should be kept in a secure environment such as a locked filing
cabinet in a locked room and away from risk of environmental
damage such as damp, fire, pests.
Where will CRFs be archived after the study? CRFs
must be archived in a secure location but accessible in case of
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inspection.
If study is multi-centre, are principal investigators
keeping an original or certified copy (printout of CRF
signed & dated by PI) of the CRF in the Investigator
Site File for the duration of study and archive?
Data base lock
Confirm that the database will be ‘locked’ after:
 study completion (usually last patient, last
visit)
 completion of coding and data entry,

all data queries resolved,
 study team notified of date of lock.
Confirm that a copy of the database will be sent to
HEY R&D prior to the statistical analysis.
Confirm that for single or double-blind randomised
HEY CTIMPs, R&D will be sent a copy of the ‘locked’
database and end of trial notification before the
randomisation list will be released by pharmacy or
other organisation in charge of randomisation.
[Insert investigator name] (Chief/PrincipaI/Co- investigator)
Sign …………………………………….. date ………………
[Insert statistician name] (Statistician)
Sign …………………………………….. date ………………
[Insert monitor name] (Clinical trial GCP monitor)
Sign …………………………………….. date ……………….
o
o
Send a signed copy to the monitor for signing and dating.
Keep a fully signed copy in the section of the Trial Master File in which the file note applies.