Randomisation and trial supply management (RTSM) is the software that decides, at random, which patient in a clinical trial gets the medicine being tested and which gets a dummy, and makes sure each hospital has the right packs in stock. It is also called interactive response technology (IRT).
Why at random? If doctors chose who gets the new medicine, they might give it to the healthier patients, and the medicine would look better than it is. A random choice makes the two groups alike, so any difference at the end is caused by the medicine. The dummy is called a placebo. It looks, tastes and is packed exactly like the real medicine. Neither the patient nor the doctor knows which one the patient receives. This is called blinding.
Say a trial is testing a new tablet for kidney disease, with half the patients on the tablet and half on a placebo. A patient at a hospital in Kochi passes screening. The research coordinator logs in to RTSM and enters the patient's number. RTSM looks up its hidden list, which the trial's statistician prepared before the trial began. The list puts this patient in the tablet group. But RTSM shows only a kit number: kit 2047. The hospital pharmacist gives the patient kit 2047. The box looks the same as every placebo box, so nobody at the hospital learns the group.
The second job is supply. Each kit has an expiry date, and many must be stored cool. RTSM knows how many kits each hospital holds. After kit 2047 is given out, the Kochi hospital has only three kits left. RTSM orders ten more from the trial's depot in Bhiwandi, near Mumbai. Each shipment's temperature is tracked, following the rules of the cold chain, and shipments can be followed on a supply chain visibility platform. If a shipment gets too warm, RTSM blocks those kits from use.
What if a patient has a medical emergency and the doctor must know what the patient took? RTSM lets an authorised doctor reveal that one patient's group. It records who did it, when and why. The rest of the trial stays blinded.
RTSM sends each patient's kit numbers to electronic data capture (EDC). At the end of the trial, it releases the hidden list to the clinical trial data platform, so that the statisticians can compare the groups.