Some clinical trials will require ancillary supplies such as sharps containers, blinding bags, or IV tubing in addition to investigational study drug as part of the protocol. Managing ancillary supplies and study drug using an IRT system requires special consideration.
First consider if the ancillary supplies need to be serialized or if they can be handled in a bulk manner. It’s critical that your chosen IRT platform’s drug management be able to handle bulk supplies for these situations. Also consider if you want an absence of ancillary supplies at investigational sites to prevent a subject visit from occurring in IRT. Most IRTs are set up by default to prevent visit transactions from proceeding if all kit types required are not present. This is important because particular supplies such as blinding bags can be re-used and you wouldn’t want to turn a subject away from a randomization visit if the ancillary supplies could be re-used.
Also consider if you want the ancillary supplies automatically replenished via IRT drug management or if you want to consider creating a custom module in the IRT to allow sites to order supplies as needed.. One consideration in this decision is can the supplies can be used again. Cost may also be a concern; therefore, if you are uncomfortable with a site being able to place orders for supplies at any point, you may want to leave replenishment up to the IRT automated drug ordering.
Another consideration is how the IRT handles shipping ancillary and study drug. For example, you may want to design your system so ancillary supplies are shipped under ambient temperature rules if your study drug is cold chain. This would prevent a scenario where both ancillary supplies and study drug would be held in quarantine for temperature excursion. This would prevent ancillary supplies from being needlessly held in a quarantined status when they may be needed.
Being aware of how ancillary supplies may affect IRT design when choosing a system can make life easier for you and your study team. Remember to pay special attention to the IRT’s standard drug management functions which can help you determine how much customization, if any your study will require.