Managing Investigational Product (IP) supplies is an important aspect of a clinical trial. This process must be followed correctly to have proper IP accountability, which leads to better quality control, subject safety, and study data integrity.
According to FDA’s Code of Federal Regulations (CFR) and Good Clinical Practice (GCP) guidelines, detailed IP accountability records must identify the personnel to whom the investigational drug product is shipped, as well as the date, quantity, and batch or code mark of such shipment.
To manage this process, it is necessary to keep in mind the trend of subject enrolment and on-site IP status to provide a fine balance in IP stock and supply. If the planning and monitoring are not precise, the study may undergo a supply stock-out, causing the study to be disrupted.
RTSM Role in Stock and Supply Monitoring
Today's clinical trial solutions often include a Randomisation and Trial Supply Management (RTSM) module that enables the interaction between IP allocation and drug supply in a reasonable manner. The reality is that the majority of these solutions are not as optimally integrated as they should be, so users must often switch between multiple systems and manually copy/paste to complete the process.
In the digital era, this is preventable, and it must be managed so that the logistics are simplified, and site personnel can dedicate more time to patients. On the other hand, this reduces errors, ensures proper tracking and documentation of the process, resulting in saving time and budget.
Advantages Through Automation
The RTSM module of the Oomnia Clinical Research Information System (CRIS) provides automatic process reconciliation powered by modern web-based interface. This includes the ability to instantly create and verify IP shipments, as well as tracking codes and temperature logs.
When a shipment is received, the site staff can record the package delivery status and temperature log conditions in just a few clicks. If any discrepancies are found, the system will automatically quarantine the IP shipment until resolution. Once the shipment receipt is complete, the IP kit is assigned to the study site and made available for allocation to study subjects directly through eCRF.
The Oomnia CRIS system offers multiple benefits to its users, such as real-time tracking and reporting, and instant visibility into IP kit location and allocation status. Coupled with real-time data processing and supply chain visibility, the system users can experience seamless integration between manufacturing, IP supply, and stock monitoring. This unified approach results in the most effective and efficient IP accountability processes.
If you would like to learn more, please contact us for a free demo!
References:
- Investigational New Drug Application, 21 CFR 312 www.ecfr.gov/cgi-bin/text-idx?SID=0261b7eecf94ba de1f78efd3b22ee7f6&mc=true&node=pt21.5.312&rg n=div5 (accessed 2022 Apr 07).
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonized tripartite guideline: guideline for good clinical practice. J Postgrad Med. 2001; 47:45–50.
- Recordkeeping and record retention (21 CFR 312.57). www.ecfr.gov/cgi-bin/text-idx?SID=10f9559cb05469 f95eb97b446651b615&mc=true&node=se21.5.312_1 57&rgn=div8 (accessed 2022 Apr 08).