IRT Reconiliation

 

• IRT reconciliation : reconcile header data eg:subjectid,site id etc…

1. IRT=interactive response or randomization Technology

2. IRT helps clinical trial sponsors & site for manage the patient & drug supply logistics—-->because =ability to offer control & flexibility while increasing efficiency

   

IRT system⮜⮜⮜⮜⮜⮜⮜⮜⮜⮜⮜⮜⮜⮜⮜⮜

🠋⮟ manages 🠟

Randomization of patients ⮟ helps

into particular treatment ⮟

🠋🠋 ⮟

Patient receives sites

↙ 🠋 ↘ 🠟

 placebo drug combination schedule patient visit from

of drug initial screening until the

end of the treatment

                                                                                                                            

3. IRT also helps to maintain blinding by making sure that specific roles in a study do not know the treatment that each patient is receiving

4. CDM reconcile below list:                                                                                       

• 

  Screening date

• 

  Re-screening date

• 

  Randomization number

• What is IRT and How Does it Impact Clinical Trials?

• What is Interactive Response Technology (IRT) or Randomization and Trial Supply Management System (RTSM)?

  An IRT system is known by many other names such as IVRS, IWRS, IXRS, RTSM but regardless of its name, the system delivers a wide range of features for managing patient enrollment and drug supply activities throughout the clinical trial lifecycle.

  What are the benefits of using IRT to Support Patient Enrollment into a Clinical Trial?

  Patient Enrollment, Randomization and Blind Protection – Utilizing the IRT to handle the enrollment and/or randomization automates the process and eliminates human error compared with manual methods. The system allows for complex protocol enrollment and randomization design and strictly controls sensitive information such as treatment arm and medication treatment assignments to maintain study blinding.

  How are Patients Randomized using IRT?

  The IRT will systematically randomize patients by assigning them to a treatment arm. There are several common methodologies which can be used such as central, subject stratified and/or site stratified randomization schemes. At the randomization visit, the IRT will assign the subject the appropriate treatment arm based on the programmed randomization methodology. The IRT will typically also assign the subject the appropriate medication kit which matches the randomized treatment arm.

• What if I Choose not to use an IRT for Randomization?
  How does the IRT help protect the study blind?

  To truly appreciate how efficiently an IRT randomizes patients in a double-blind trial, just look at how it was done prior to the availability of IRT. When an IRT is not utilized, each entry on the patient randomization list is associated with a treatment type and matching kit number. The number is sealed in an envelope bearing a sequence number. A block of envelopes and the associated kits are sent to the investigational site where envelopes are chosen in sequence. The matching kit is then dispensed to the patient. While this method is reasonably efficient on an extremely small scale, it is slow and only works with simple randomization designs. Plus, it is subject to human error. When IRT handles randomization, the process is automated and centralized. It can accommodate complex stratification and randomization design that would not be possible with manual randomization. Randomization happens without human intervention, and therefore reduces human error. And, as with other aspects of study management, the system stores the data for easy tracking.  Automating the randomization and drug assignment process eliminates the need for paper envelopes or cards to be stored at the site where unblinded information could be compromised.

• What are the benefits of using IRT for Supply Management?

  Individual kits stored at the depot and site are not labeled for particular patients. Instead, kits are assigned to patients when they arrive for their visit. So, shipments to sites only contain enough product to meet patient demand over a certain period, and resupplies are triggered when inventories hit a designated level. This process maximizes drug availability at the site, since products are only allocated to patients when they come in for visits and minimizes drug wastage. The IRT is able to tailor the supply provided to each site since it knows what patients are at each site, their treatment arms, and the visit schedule.

  Developing and maintaining an accurate forecast of product demand over the course of a clinical trial is essential to controlling costs. The IRT provides Supply Chain Managers with real-time updates of what is happening with patient enrollment and product inventory throughout the supply chain. This aids with budget preparation, prevents wastage that comes from stockpiling supplies, avoids the risk of stock-outs, and reduces emergency measures needed to replace expiring drugs.

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