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Protocol and Study Design |
- 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. - 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. - 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)
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