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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.
Protocol and Study Design
  1. If a study is conducting in different countries, is it required to have same version of all protocol in all the countries?
    It depends on 1) which is the final version 2) what are the differences in versions 3) whether the different versions represent the amendments.
  2. Is there any difference between protocol deviation and violation?
    Protocol Deviation: Any alteration/modification to the IRB-approved protocol. The protocol includes the detailed protocol, protocol summary, consent form, recruitment materials, questionnaires, and any other information relating to the research study.
    Protocol Violation: Any protocol deviation that is not approved by the IRB prior to its initiation or implementation.
    Major Violation: a violation that may impact subject safety, affect the integrity of study data and/or affect subject's willingness to participate in the study.
    Minor Violation: a violation that does not impact subject safety, compromise the integrity of study data and/or affect subject's willingness to participate in the study.
  3. Is it required having a sponsor's approval page in the protocol?
    Yes. Usually the signature page comes after the title page and contains space for all signatures
    Investigator
    Sponsor responsible person usually medical director / head clinical research
    Sponsor's statistician (if applicable)
  		 


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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