I titrated up or down in error

If you titrated up or down in error, there are ways to fix the error from within Oracle Clinical One Platform. Your next steps depend on the blinding status of the kits that were dispensed.

Unblinded kits

You should work with the Clinical Research Associate (CRA) 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 you titrated 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. You work with the study team to 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. Along with the study team, identify the kit number of the kit to remove.
3. You then mark 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

For unblinded kits, you should reach out to your Clinical Research Associate (CRA), 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 you titrated 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 Clinical Research Associate (CRA), who then tells you.
3. You then mark 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.