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Q of the week

Q: How Do You Get Shingles?

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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.
Confidentiality
  1. What do companies do with respect to confidentiality by subjects on a trial?
    No company attempts to obtain confidentiality agreements from patients, and investigators are not asked to do this.
  2. Are there any guidelines or legal information available on the release of patient medical records or information to CRO for the purposes of identifying potential study patients?
    The investigator has a responsibility according to ICH GCP Guideline E6 section 4.2.1 "to demonstrate a potential for recruiting…subjects" but this does not mean providing personal patient information or medical records. The ICH guidelines covering confidentiality indicate that medical records should not be released to companies for such purposes. In addition, the sponsor company should not have access to the patient’s medical records to be able to release them to a third party.
  		 


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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