Presentation on theme: "HOT TOPICS ARCHIVING OR HOW NOT TO DUMP YOUR RUBBISH!"— Presentation transcript:
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.