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Accrual Access Requirements and Rules
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Requirements for granting/denying access include the following:
- Processing status – Must be at least "Verified" (response or no response). See Trial Processing Statuses.
- Site recruitment status – Must not be "Withdrawn" nor "Not yet Recruiting". The participating site must have accrued patients at some point in the past, or is accruing patients currently.
- Action – You can grant or deny access to the Accrual site only when abstracting or validating the trial for which access is requested.
Once assigned, users can submit accrual data for all trials associated with their affiliated organization or organization family members. For Complete trials (Institutional and Externally Peer Reviewed), the organization must be a lead; for Abbreviated trials (Institutional), the organization must be a participating site.
Assignment at the organization or family member organization level pertains to trials that the organization has registered in CTRP and extends to those that it will register in the future.
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Complete trials for which the assigner's organization is the lead organization
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Abbreviated trials for which the assigner's organization is the Lead Organization or participating site
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- By trial
- By Organization
By Organization Family member
Footnote The system automatically assigns the Organization Family Accrual Submitter access to any trial registered by new organizations added to an organization family in the future. It withdraws access if the Organization Family Accrual Submitter's organization is removed from the organization family in the future.
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- By trial
- By participating site
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- All Complete trials registered by the submitter's organization or family member organization
- Trials currently registered in CTRP
- Trials that the organization registers in CTRP in the future, once abstracted
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- All abbreviated trials registered by the submitter's participating site only
- Trials currently registered in CTRP
- Trials that the organization registers in CTRP in the future, once abstracted
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Setting Up Accrual Access
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When you receive a CTRO request for access, you must associate the user with the appropriate trial/site. Thereafter you can grant or deny the user access without having to repeat the setup.
Organization Administrators assign Accrual access in CTRP Registration. However, you still can use this feature in the Protocol Abstraction application to process requests that have been sent to the CTRO.
How to Manage Accrual Access
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Select or enter the appropriate information in the text fields and drop-down lists. Fields are described in the following table. All fields are required.
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Trial Description
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Instruction
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User Name
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Select the appropriate registered user from the drop-down list.
The user’s email address and phone number fields are populated automatically.
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Accessing Site
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Select the appropriate participating site. The Site Recruitment Status field is populated automatically.
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Access Status
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Select either Active, to grant access, or Inactive, to deny access.
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Request Details
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Optionally, type the details of the request as recorded by the CTRO.
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Activating and Inactivating Accrual Access
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Once a user has been set up for a given trial/site, you can grant (Activate) or deny/revoke (Inactivate) the user’s access.
How to Activate and Inactivate Accrual Access
- Follow the steps in the previous section to navigate to the Manage Accrual Access page.
- Locate the user’s record, and click the Edit icon.
The Edit User’s Access page appears. All fields accept the Access Status and Request Details are unavailable for editing. - From the Access Status drop-down list, select either Active, to grant access, or Inactive, to deny access.
- Optionally, in the Request Details field, edit or add text as necessary.
- Click Save.
The record is updated on the Manage Accrual Access page.
