In ICH E8 8.2.12 (and 8.3.7) (Medical/Laboratory/Technical procedures/tests) is has:
-Established quality control and/or external quality assessment or
-other validation (where required)
Typically, when “or” is used in this fashion it means any of the 4 options is fine and that you do not need all 4. In the TMF Ref Model, 08.01.01 (Accreditation),08.01.02 (Lab Validation),08.01.07 (Head of Facility CV) and 08.01.08 (Standardization Methods) are all listed as “Core”(except for CV) and as “dependent on type of study”. This has led to some confusion, especially from the labs when asked for these types of documents. My interpretation of 8.2.12 (E8) would be that as long as you have one of the 4 listed options, you do not need the other 3. Since most labs used by the sponsor are accredited, they would not have to provide Lab Validation docs or standardization methods. At least, this is what the labs are telling us. Would you agree that only one of the 4 is required? Also, can you clarify what “dependent on type of study” means? I assume it means studies that use labs for any protocol testing. Plus, there is that pesky “where required”. Is this country specific? Thanks again!