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?
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- 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.
- Contact Oracle Support.
- What if I open a study, and it says I have no sites?
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- Verify that you created sites for Testing mode.
- Make sure the sites are all activated.
- Contact Oracle Support.
- What if shipments aren't being raised?
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- 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.
- Make sure the study has a kit list for Testing mode.
- 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.
- If your study requires label groups:
- 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.
- Check that the site:
- 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.
- Contact Oracle Support.
- What if I can't create shipments in a study I am trying to verify?
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- Check your depots:
- Make sure that kits that are assigned to the depot are also assigned to a manufacturing lot.
- 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.
- If your study requires label groups:
- If your study requires label groups, make sure each kit is assigned to a label group.
- 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.
- Contact Oracle Support.
- What if I can't add subjects in a study I am trying to verify?
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- 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.
- Check with an administrator to make sure you have a site user role for Testing mode. For instructions, see Create study user accounts.
- Check whether the limits for the study have been met, and make sure enrollment isn't closed.
- Contact Oracle Support.
- What if I can't randomize subjects or dispense kits in a study I am trying to verify?
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- Make sure the subject came in within the visit window, if the study doesn't allow dispensation out of window.
- 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.
- Make sure the study has:
- Confirm that the randomization list is assigned to the study version that you are verifying.
- Check that kits are assigned to the site.
- 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.
- 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.
- If you are randomizing into stratum groups, make sure the stratum groups don't have overlapping ranges.
- Contact Oracle Support.
Parent topic: Verify a study in Testing mode