What if I have problems trying to verify a study?

If you run into problems while verifying your study in Testing mode, these troubleshooting tips will help you get back on track.

Having problems with a live study?

What if I can't work in a study?

1. Ask a user administrator to confirm your effective date range in the study is not in the past or future. For instructions on creating users, see Create study user accounts.
2. Contact Oracle Support.

What if I open a study, and it says I have no sites?

1. Verify that you created sites for Testing mode.
2. Make sure the sites are all activated.
3. Contact Oracle Support.

What if shipments aren't being raised?

1. If shipments were created in the past and aren’t being created anymore: Make sure a study version is assigned to the site. If the site uses predictive resupply and doesn’t have a study version assigned to it, the supplies that are needed at the site can’t be predicted, so no shipments are created.
2. Make sure the study has a kit list for Testing mode.
3. Check your depots:
   • Make sure a depot is assigned to send shipments to the country that the site is in.
   • Check that depots are activated.
   • Check that kits are assigned to the depot.
4. If your study requires label groups:
   1. Make sure each kit is assigned to a label group.
   2. Make sure that kits of each type are in label groups that are allowed to be sent to the site(s) that are missing shipments.
5. Verify the following information for the manufacturing lots (and blinded lots, if you are using them):
   • Expiration dates of all lots are in the future.
   • Expiration dates of all lots are late enough that kits can still be dispensed in consideration of the Do Not Ship (DNS) Days value for the manufacturing lot.
6. Check that the site:
   • Has been activated.
   • Has a resupply strategy associated with it.
7. Check the event that triggers the first shipment, either site activation or the first subject who starts a specified visit. A shipment is created only after the selected event occurs.
8. Contact Oracle Support.

What if I can't create shipments in a study I am trying to verify?

1. Check your depots:
   • Make sure a depot is assigned to send shipments to the country in which the site exists.
   • Check that kits are assigned to the depot.
2. Make sure that kits that are assigned to the depot are also assigned to a manufacturing lot.
3. Verify the following information for the manufacturing lots (and blinded lots, if you are using them):
   • Kits of every type are assigned to a lot.
   • Expiration dates of all lots are in the future.
   • Expiration dates of all lots are late enough that kits can still be dispensed in consideration of the Do Not Ship (DNS) Days value for the manufacturing lot.
4. If your study requires label groups:
   1. Make sure each kit is assigned to a label group.
   2. Make sure that the kits you're trying to add to the shipment are in label groups that are allowed to be sent to the site you're creating a shipment for.
5. If your study requires label groups, make sure each kit is assigned to a label group.
6. If the study allows single kit ordering, check whether the depot has the right combination of kits. If not, make kits available at the depot.
7. Contact Oracle Support.

What if I can't add subjects in a study I am trying to verify?

1. If you have access to multiple sites, make sure the site you're verifying is selected from the Site drop-down, to the right of the Manage Subjects drop-down.
2. Check with an administrator to make sure you have a site user role for Testing mode. For instructions, see Create study user accounts.
3. Check whether the limits for the study have been met, and make sure enrollment isn't closed.
4. Contact Oracle Support.

What if I can't randomize subjects or dispense kits in a study I am trying to verify?

1. Make sure the subject came in within the visit window, if the study doesn't allow dispensation out of window.
2. Ask a user administrator to verify that you are assigned to:
   • A site user role for Testing mode. For instructions, see Create study user accounts.
   • The site you're trying to work with for Testing mode.
3. Make sure the study has:
   • A kit list for Testing mode.
   • A randomization list for Testing mode.
4. Confirm that the randomization list is assigned to the study version that you are verifying.
5. Check that kits are assigned to the site.
6. Verify the following information for the manufacturing lots (and blinded lots, if you are using them):
   • Kits of every type are assigned to lots.
   • Expiration dates of all lots are in the future.
   • Expiration dates of all lots are late enough that kits can still be dispensed in consideration of the DND (Do Not Dispense) value for the visit.
7. Check whether the screening, randomization, and cohort limits have been met. If the cohort limit has been met, make sure that a cohort that hasn't reached its limit is open.
8. If you are randomizing into stratum groups, make sure the stratum groups don't have overlapping ranges.
9. Contact Oracle Support.