South Africa Clinical Trial Inspections by MCC

Q

QualityAnalyst1

Does anyone have any experience with clinical trial inspections by the MCC (Medicines Control Council) of South Africa? What I am trying to find out is if an inspection of a clinical trial site is limited to looking at the site and the site's data, or if it also includes sponsor related items. I haven't been able to find anything like examples of what has happened in other inspections. In section 5.3 of their GCP guideline it says that inspections are only done for cause, but later in that section it says that inspections may be carried out randomly, and/or for specific reasons. If anyone is familiar with these inspections, or could suggest where I might look for more information, I would very much appreciate it. Thank you in advance.
 
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