What if users have problems working in a live study?

If users run into problems while working in a live study, these troubleshooting tips will help you get everyone back on track.

Having problems trying to verify a study?

What if someone can't work in a live study?

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

What if someone opens a study, and it says they have no sites?

1. Verify that you created sites for Production 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 production mode.
3. Check the depots:
   1. Make sure a depot is assigned to send shipments to the country in which the site exists.
   2. Check that depots are activated for production mode.
   3. Check that kits are assigned to depots.
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 allowed to be sent to sites are assigned to a label group, specially check for those sites that are missing shipments.
5. Verify the following information for the manufacturing and blinded lots, if you are using them:
   1. Make sure kits of every type are assigned to a lot.
   2. Check expiration dates of all lots to be in the future.
   3. Check expiration dates of all lots to be late enough that kits can still be dispensed in consideration of the Do Not Ship (DNS) Days value for the manufacturing lot.
6. Check the site:
   1. Verify the site has been activated.
   2. Make sure the site has a resupply strategy associated with it.
7. Check the event that triggers initial shipment defined when specifying supply settings, either site activation or the first subject who starts a specified visit, has happened.

   Note:

   An initial shipment is created only after the selected event occurs.
8. Contact Oracle Support.

What if a depot can't raise shipments in a study, or a site can't request manual shipments?

1. If the site can't request a manual shipment, check whether the study allows sites to request shipments specified in supply settings.
2. Check the depots:
   1. Make sure a depot is assigned to send shipments to the country in which the site exists.
   2. Check that kits are assigned to depots.
3. Make sure that kits that are assigned to the depot are also assigned to a manufacturing lot.
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 allowed to be sent to sites are assigned to a label group, specially check for those sites that are missing shipments.
5. Verify the following information for the manufacturing and blinded lots, if you are using them:
   1. Make sure kits of every type are assigned to a lot.
   2. Check expiration dates of all lots to be in the future.
   3. Check expiration dates of all lots to be late enough that kits can still be dispensed in consideration of the Do Not Ship (DNS) Days value for the manufacturing lot.
6. Verify in the supply settings if the study allows single kit ordering and check whether the depot has the right combination of kits. If not, make kits aavailable at the depot.
7. Contact Oracle Support.

What if a site user can't see shipments that are In Transit?

• Make sure the site user is assigned to the appropriate sites and depots.

What if a site user can't add subjects in a study?

1. If the site user has access to multiple sites, tell the user to make sure the site is selected from the Site drop-down, to the right of the Manage Subjects drop-down.
2. Make sure the user has a site user role for Production mode. For instructions, see Create study user accounts.
3. Check in the study, enrollment and visit settings, whether the limits for the study have been met, and make sure enrollment isn't closed.
4. Contact Oracle Support.

What if a site user can't randomize subjects or dispense kits in a study?

1. Make sure the subject came in within the visit window, if the study doesn't allow dispensation out of window.
2. Ask the site user to make sure that all required questions are answered.
3. Ask a user administrator to verify that the site user is assigned to:
   • A site user role for Production mode. For instructions on assigning roles, see Create study user accounts.
   • The site that the user is trying to work with for Production mode.
4. Make sure the study has a kit list for production mode.
5. Make sure the study has a randomization list for production mode.
6. Confirm that the randomization list is mapped to the correct study version, the one you are making live.
7. Verify that kits are assigned to depots and have the status of Available.
8. Make sure the site has kits to dispense.
9. Verify the following information for the manufacturing and blinded lots, if you are using them:
   1. Make sure kits of every type are assigned to a lot.
   2. Check expiration dates of all lots to be in the future.
   3. Check expiration dates of all lots to be late enough that kits can still be dispensed in consideration of the Do Not Ship (DNS) Days value for the manufacturing lot.
10. Check in the study, enrollment and visit settings whether the screening, randomization, and cohort limits have been met. If the cohort limit has been met, make sure the next cohort is open.
11. If you are randomizing into stratum groups, make sure the stratum groups don't have overlapping number ranges.
12. Contact Oracle Support.