IWRS and IP accountability records
[COLOR=#58595B][FONT=Rubik]Hello,
When a sponsor decides to use an IWRS system to control the IP management at site (receipts, dispensations, returns, destructions), can the IWRS be considered the source data for the IP accountability?
[/FONT][/COLOR][COLOR=#58595B][FONT=Rubik]As I understand it, the investigator should have and own records of all IP transactions (for instance, an IP acknowledgement of receipt, IP dispensation form, a destruction certificate, etc). These are the source documents of these transactions. BUT, my question is: which one is the source document for IP accountability? (understanding IP accountability as the inventory, i.e. the result of adding (receipts) and subtracting (administrations, etc) all transactions). IWRS is a place where the inventory is automatically calculated with no errors. The investigator would still own all the source documents of all IP transactions. Except for IP accountability: that piece of information is calculated in IWRS. My question then is: is it also necessary to have a separate IP accountability log (often paper-based) at site where all the transactions AND the calculation of the IP inventory is also performed? Wouldn't that be duplicating information that is already in IWRS?
Thank you! [/FONT][/COLOR]