HOW NOT TO DUMP YOUR
Legal requirement for a Clinical Trial of an
Investigational Medical Product
Essential documents should be retained by the PI until
informed by the sponsor that they are no longer needed
(written agreement obtained)
The sponsor and the Chief Investigator shall ensure that
the documents contained in the trial master file and the
medical files of subjects are kept for at least 5 years from
defined start point of archiving.
Sponsor to appoint named individuals responsible for
archive (restricted access to those individuals)
UK Regulations 2006
Enable both the conduct of the clinical trial and the quality
of the data produced to be evaluated
Show whether the trial is or has been conducted in
accordance with applicable requirements
Shall contain information relating to each phase of the trial
(before, during, after) eg, minutes, training records,
calibration records, statistical reports
Sponsor shall keep a Trial Master File
Should be filed in an organised way that will facilitate
management, audit and inspection of the trial
Complete and legible with a validated system of transfer to
other media (eg. floppy discs in 20 years may not be)
Suitable space with appropriate environmental control and
protection from physical damage
Archive index/log maintained to track documents
Named Investigator responsible for archiving essential
documents and should inform sponsor if responsibility
transferred due to eg. relocation or retirement
SRHT SOP 009 (2007)
All trial data must be kept so that the data
can be accessed after the trial has
Good Clinical Practice Guidelines specify
which documents are essential for a
For commercial trials documentation
needs to be retained for at least 15 years.
(ICH GCP guidelines)
Documentation can be archived by the
PI or the sponsor.
If the PI leaves or changes during the
archival period a handover of
responsibility must be documented.
Archiving must be done as soon as
possible after the completion of a study –
but can be ongoing throughout the trial.
Material should be stored correctly – in
labelled archive boxes.
Example of Label
Sponsor Name, Protocol Number, Ethics Number
Principal Investigator, Co-Investigator & Contact
Department X, Hospital
Box [insert number] of [insert total number]
(Brief description of content)
Archive from [insert date] until [insert date]
Secure - Access is limited to PI, Sponsors
and regulatory authorities.
Under constant environmental conditions
– temperature, humidity and pest control.
Archive log - Retrieval of items etc.
Example of archiving log
Ethics Number _ _ _ / _ _
Please detail below the Case Record Form Numbers
Please indicate the number of archiving boxes, specific contents per box and exact
Contents of Box Storage Location
· Archive storage labels should be put on each storage box
· Any details regarding a change in storage during the archiving period should be
· The Investigator Declaration should be completed
· This log should be stored in a specified location by
Principal Investigator Declaration
· All essential documents are filed within the Investigator File as per the requirements
· All consent forms are in the Investigator File in numerical order
· The archive boxes will be stored as per requirements to conform to ICH-GCP
Principal Investigator signature…………………………………………………………...
Medical / Pharmacy records
Participant’ clinical notes must also be
retained – can be as electronic format.
Pharmacy records if drug trial must also
Company data relating to trial orthopaedic
implants for example must also be
Destruction of Data
Data is destroyed according to guidelines.
A record of destruction of essential
documentation needs to be kept for a
further 5 years from destruction date.
Details of data should be available at any
time for Regulatory bodies to inspect.