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Hello GCSG Hive!
Two questions here:
1) Has anyone else been experiencing a resistance from clinical sites to complete the Accountability and Reconciliation in your IRT systems? We have several sites pushing back saying it is not their process and they will only perform this activities in their own pharmacy inventory systems.
1a) If you have experienced sites refusing to finish out these activities in your IRT, what have you done instead to show 100% A/C?
2) In terms of diluent – if you provide any type of SWFI or other solutions for use in diluting/reconstituting product, in which you label for your clinical trial, what is the Accountability/Reconciliation requirement? Is it still 100%?
– For additional background, this is diluent that we manufacture on commercial lines and is USP compliant/approved. We take the bulk, unlabeled vials from our manufacturing site and label for use in our studies.