HOT TOPICS ARCHIVING OR HOW NOT TO DUMP YOUR RUBBISH!

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

Archiving  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 finished.   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 details   Department X, Hospital   Box [insert number] of [insert total number]   (Brief description of content)   Archive from [insert date] until [insert date]   PDF created

Storage  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 retained.

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.