Oct 11, 2012 10:33
12 yrs ago
English term

qualification

English Medical Medical (general) clinical trials
In Bangladesh, XXX has well established contacts with the leading investigators and physicians of the country and is capable of running the project end to end. The company's in-house Regulatory team handles the regulatory submissions and Ethics Committee [EC] submissions at Bangladesh Medical Research Council (BMRC); the regulatory body for governing clinical trials in Bangladesh. Also for overall project management of the study, XXX CRAs and PMs will manage site selection, ***qualification***, and monitoring of all sites, to ensure that the study is conducted per ICH GCP and local regulatory guidelines.

Responses

+3
2 mins
Selected

determining which sites qualify for participation in the study

that would be my reading, though odd that it should come after selection - the two would normally be the other way round.

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Note added at 12 mins (2012-10-11 10:46:01 GMT)
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i.e. which sites meet the requirements for inclusion in the study
Peer comment(s):

agree Yvonne Gallagher : select sites and then verify that they actually qualify...
11 mins
ah yes, makes sense.
agree Trudy Peters
3 hrs
Thanks
agree Tina Vonhof (X)
4 hrs
Thanks
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4 KudoZ points awarded for this answer. Comment: "Gracias"
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