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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.

Computer Questions and Internet
  1. Nowadays, e-mail is a major communication tool in clinical research. To what extent should e-mails be printed as a paper trail according to GCP or according to the "spirit" of GCP? Should all of them be printed and kept or would it be sufficient to keep the e-mails electronically with a good backup system in place. Do we need to separate site communications from internal e-mail in this respect?
    It was agreed that it is currently general practice within the industry to print all E-mails off and file them as for any other record.  For communication with the investigator, it was recommended that these be signed and dated before filing.  Internal E-mails need not be signed or dated, but should be filed, and separately from the site communication.

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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