To account all the Supplies of Clinical Trial is a Regulatory requirement. Traditionally people used to use paper based or Excel based tracking of the Supplies. This is tedious, time consuming and error prone. DDi has built a robust and plug and play Supplies Accountability module into its mIRT. Supplies accountability starts with tracking Supplies arrived at Site and ends once all the Supplies are Destructed or some of the Supplies are Lost status. Below is the functionality
Reconcile – Accounting the Drug Product (Dosage form of Drug Product – Tablets, Capsules, Liquid, Powder etc.). User will update the amount of Drug Product given to Subject, Returned in good condition or damaged condition and lost with the comments
Compliance Calculation (Example) – Compliance = Consumed Capsules/(Number of days from Assigned/Start Date to End Date)/No. of Units Per Day X 100
Return – updating the status of Kit to Returned
Destruction – Updating the status of the Kits to either Destructed or Lost
Any of the above functionality can be easily added or deleted or minefield for a project through sittings based on the Protocol. Permission for users like Investigator, Site Coordinator, Pharmacist, Study Nurse, Depot, Monitor, Sponsor or any other user can be managed depending on the protocol.
Status of Kits in Supplies Accountability: The status of the Kits in this module is independent of Supplies module so that the Clients will have more visibility into the different status of the Kits.
Supplies Accountability Reports: Intuitive, robust and actionable.