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            Document Retention
    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)
              Essential Documents
              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
    clinical trial.

   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
   Protocol Title
   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]
   PDF created
   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
   Sponsor Name
   Protocol Number
   Ethics Number _ _ _ / _ _
   Protocol Title
   Investigator
   Directorate
   Please detail below the Case Record Form Numbers
   Please indicate the number of archiving boxes, specific contents per box and exact
   storage location
   Contents of Box Storage Location
   Box 1
   Box 2
   Box 3
   Box 4
   Box 5
   Box 6
   · Archive storage labels should be put on each storage box
   · Any details regarding a change in storage during the archiving period should be
   documented
   · 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
   of ICH-GCP
   · 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…………………………………………………………...
   Date:……………………………………………………………………………………..........
   PDF
     Medical / Pharmacy records
   Participant’ clinical notes must also be
    retained – can be as electronic format.

   Pharmacy records if drug trial must also
    be retained.

   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.

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