What if a site user dispensed a kit in error?

You next steps depend on what happened.

What if Oracle Clinical One Platform dispensed a kit, but the subject left the site without it?

1. Tell the site user to dispense a replacement kit to the subject if he or she needs one.

   Caution:

   A site user must dispense a replacement kit before marking the kit as Not Dispensed to Subject. If a site user marks a kit as Not Dispensed to Subject before dispensing a replacement kit, the site user won't be able to dispense a replacement kit.
2. Tell the site user to mark the kit that the subject didn't receive as Not Dispensed to Subject.

What if a site user gave a subject a kit that was different from the kit that Oracle Clinical One Platform said to dispense, and the subject left the site with it?

Perform these steps only if it is determined that the subject can continue with the study.

1. Tell the site user to dispense a replacement kit to the subject.

   Caution:

   A site user must dispense a replacement kit before marking the kit as Misallocated. If a site user marks a kit as Misallocated before dispensing a replacement kit, the site user won't be able to dispense a replacement kit.
2. Mark the kit that the subject left the site with as Misallocated.

   From the Subject Number drop-down, tell the site user to select the subject who received the kit.

What if a site user entered data for the wrong subject?

1. Tell the site user to dispense a replacement kit to the subject whose visit the site user mistakenly entered data in.

   For example, if the site user entered data for subject 001-001 in the visit for subject 001-002, the site user should dispense a replacement kit for subject 001-002.

   Caution:

   A site user must dispense a replacement kit before marking the kit as misallocated. If a site user marks a kit as Misallocated before dispensing a replacement kit, the site user won't be able to dispense a replacement kit.
2. Tell the site user to mark the kit that was dispensed as Misallocated.

   From the Subject Number drop-down, tell the site user to select the subject who received the kit.

   For example, after the site user dispenses a replacement kit for subject 001-002, tell the site user to mark the kit dispensed in error to subject 001-001 as Misallocated, and select subject 001-001 from the Subject Number drop-down.

3. If the subject who received the wrong kit can continue in the study, tell the site user to enter data for the correct subject. For example, the site user should enter the data for subject 001-001 in the visit for subject 001-001. Oracle Clinical One Platform dispenses a kit to the subject; use your organization's procedures to determine whether to exchange the kit in the subject's hands for the kit that Oracle Clinical One Platform dispensed.

What if a site user dispensed a kit without using Oracle Clinical One Platform?

Site users should never dispense a kit without using Oracle Clinical One Platform.

• Tell the site user to mark the kit as Misallocated.

  In the Subject Number field, the site user should enter the number of the subject who received the kit.

What if a site user titrated in error?

If a site user titrated up or down in error, there are ways to fix the error from within Oracle Clinical One Platform. The site user's next steps depend on the blinding status of the kits that were dispensed:

Unblinded kits

The site user should work with the clinical research associate and other members of the study team as needed to determine whether they can fix the error by not dispensing one or more kits. For example, consider a subject who is currently consuming 5 mg of an investigational product and wants to stay on the dose. If the site user titrates up in error, the subject might switch to a 7.5 mg dose, consisting of a 5 mg kit and a 2.5 mg kit. Here's what should happen in this situation:

1. The site user and sponsor team determine whether removing one of the kits from the dispensation will solve the error. In this case, removing the 2.5 mg kit does solve the problem. What if the error can't be solved by removing a kit? The error can't be solved from within Oracle Clinical One Platform. The study team must determine the next steps for the subject.
2. The site user and sponsor team identify the kit number of the kit to remove.
3. The site user marks the kit as Not Dispensed to Subject. When a kit is marked as Not Dispensed to Subject, the kit is no longer considered part of the subject's current dose. So when the subject has their next dispensation visit and they choose to maintain their current dose, they'll stay on the 5 mg dose.

Blinded kits

The site user should reach out to their clinical research associate, who should contact the clinical supply manager. The clinical supply manager should look at the kits that were dispensed to see whether they can fix the error by not dispensing one or more kits. For example, consider a subject who is currently consuming 5 mg of an investigational product and wants to stay on the dose. If the site user titrates up in error, the subject might switch to a 7.5 mg dose, consisting of a 5 mg kit and a 2.5 mg kit. Here's what should happen in this situation:

1. The clinical supply manager determines whether removing one of the kits from the dispensation will solve the error. In this case, removing the 2.5 mg kit does solve the problem. What if the error can't be solved by removing a kit? The error can't be solved from within Oracle Clinical One Platform. The study team must determine the next steps for the subject.
2. The clinical supply manager identifies the kit number of the kit to remove and shares the kit number with the CRA, who tells the site user.
3. The site user marks the kit as Not Dispensed to Subject. When a kit is marked as Not Dispensed to Subject, the kit is no longer considered part of the subject's current dose. So when the subject has their next dispensation visit and they choose to maintain their current dose, they'll stay on the 5 mg dose.

Other examples of titration dispensation errors

For example, consider the following situation: a subject who is currently on 75mg of an investigational product wants to maintain the same dose. During one of the visits, a site user titrates down in error, so the system dispenses 50mg to the subject who wanted to maintain its 75 mg dose.

Titration is based on the latest dispensation for a subject, whether it be a dispensation event that occurred through the visit or a manual dispensation (through the misallocation of a kit). A site user then chooses to perform a manual dispensation (through misallocation) to be able to dispense the right investigational product to the subject.

If a misallocation occurs for a visit in which the kit dispensed is at a higher dosage (75mg) of what was originally dispensed in the system (which was 50mg), the system will check for a matching row within the Start column of a titration kit type (in this case, the system is looking at the Start column to contain Kit Type A 50mg + Kit Type B 75mg), when performing the titration during the next visit. If there is no matching row, the dispensation will fail, as expected based on the study's design. The following error message will be displayed: “You cannot dispense a kit to subject <subject_number>. Contact your clinical research associate, and tell them to verify that titration rules have been defined for all kits.”