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HOT TOPICS ARCHIVING

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)

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HOT TOPICS ARCHIVING

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  1. HOT TOPICSARCHIVING OR HOW NOT TO DUMP YOUR RUBBISH!

  2. Document RetentionLegal 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)

  3. Essential DocumentsUK 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

  4. 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

  5. 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)

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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.

  11. 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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