Accrual Access Requirements and Rules
- 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- Site recruitment status – Must not be "Withdrawn" nor "Not yet Recruiting".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.
The table below outlines the access and trial assignment rules for Complete (Institutional and Externally Peer-Reviewed) and Abbreviated trials.
| Access/Assignment | Complete Trial | Abbreviated Trial |
|---|---|---|
| Who can assign access? | A registered user logged in as the Lead Organization's Site Administrator | A registered user logged in as the Site Administrator |
| Who can be assigned access? | Any registered user affiliated with the Site Administrator's organization, or family member organization (including the Site Administrator) | Any registered user affiliated with the assigner's organization (including the site administrator) |
| What types of trials can be assigned? | Complete trials for which the assigner's organization is the lead organization | Abbreviated trials for which the assigner's organization is the Lead Organization or participating site |
| How is access assigned? |
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| Who can submit accrual data? | Any assigned user, for any organization trials for which the assigner's organization is the Lead Organization | Any assigned user affiliated with the participating site |
| Which trials can the Organization Family Accrual Submitter submit accrual data to? |
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- 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. ↩
Setting Up Accrual Access
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
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Identification page, check out the trial for Administrative processing. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
- On the main menu, in the Trial Overview section, click Manage Accrual Access. The Manage Accrual Access page appears. It may display one or more user records if access to the trial has been granted or denied previously.
- Optionally, select a different disease code for all users from the Accrual Disease Terminology drop-down list.
- To add a user who has requested access, click Add. The Set Up Accrual Access page appears.
In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
Trial Description
Instruction
User Name
Select the appropriate registered user from the drop-down list.
The user’s email address and phone number fields are populated automatically.Accessing Site
Select the appropriate participating site. The Site Recruitment Status field is populated automatically.
Access Status
Select either Active, to grant access, or Inactive, to deny access.
Request Details
Optionally, type the details of the request as recorded by the CTRO.
- Click Save. The record is added to the Manage Accrual Access page.
Activating and Inactivating Accrual Access
How to Activate and Inactivate Accrual Access
Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
On the Trial Identification page, check out the trial for Administrative processing. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)
- On the main menu, in the Trial Overview section, click Manage Accrual Access. The Manage Accrual Access page appears.
- 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 system updates the record on the Manage Accrual Access page.
