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Q of the week

Q: Do clinical trials ever go wrong?

Get the Answer: 

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.

Source Document Verification
  1. Is it acceptable under ICH GCP to verify by means of a sample, that written informed consent has been obtained for each subject before participating in the trial?
    ICH GCP demands 100% SDV of all informed consent forms. It is particularly important to verify informed consents for studies whose primary purpose is to support product registration.
  2. Is it acceptable to provide investigators with photocopies of the CRF pages to be completed which can then be included in the patient notes as source data from which the information to be transcribed onto the official CRF?
    Yes, this is acceptable and several companies work to this practice as a standard. However it is still important to verify that the patient exists, has the disease(s) in question, actually took part in the trial and took the study drug if this method is employed.
  3. How is it possible to validate the existence of a patient or subject when there are limited notes, medical history etc?
    One suggestion both to confirm the existence of a patient and to clarify the information recorded is to write to the patient’s physician and request confirmation of the declared drugs and medical history
  4. How is it possible to obtain source documents when patients move around a lot or see several different doctors at different locations?
    On an ongoing basis, the patient notes can be requested from the other locations involved. At periodic intervals a questionnaire could be sent to the doctors involved in order to collect source data information.
  5. Use of computerized notes for SDV?
    Check the validation of the system, it should have been validated although some in use in general practice have not. If in doubt, have the investigator print the relevant part of the patient record, sign it and copy/archive.

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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