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Q of the week

Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

  1. The ICH GCP guideline states that '…essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region....'.Since it is difficult to decide when 2 years has been reached, are companies still asking investigators to archive documents for 15 years?'
    There is no definitive answer on this issue, however 15 years has been advised and is still followed by a number of sponsor companies. Common practice is for sponsors to archive the investigator documents on behalf of the investigator in a separate archive to the sponsor documents. The sponsor must inform the site when data can be destroyed.
  2. The investigator copy of the data can be archived following a study, and due to lack of suitable storage facilities at the investigator site the data may be archived on the investigator's behalf in the sponsor's external archive facility. Is it essential that the investigator copy of the data is retained and archived as data retrieval can be made from the sponsor's archive?
    It is considered preferable that two copies of the data are held at different sites to ensure that neither copy is altered and that both copies are not destroyed in accidental circumstances. If the investigator copy of the data is archived off-site, it should be sealed and stored separately from the sponsor copy data in a fireproof facility which does not have a sprinkler system. The investigator should retain a copy of the patient log, and only the investigator should recall information from this archive, signing to authorize data removal.

Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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