Using CRF Status Search Criteria

Searching by CRF Entry Status

Use the CRF Entry Status parameter to search for CRFs based on the status of the data entered into the CRF. In RDC Onsite, the formal stages of data entry track the progression of a CRF from no data entered to entry completed.

Valid values are:

All — Retrieves all CRFs regardless of their entry status. All is the default value.
Blank — Retrieves all CRFs that have a blank entry status. RDC Onsite assigns this status to a CRF that has been marked as blank. A blank CRF does not contain data. You cannot add data to a CRF while it is marked as blank.
Created — Retrieves all CRFs that have a created entry status. RDC Onsite assigns this status to a CRF when all required CRF header data has been entered and saved, and no other data (that is, no response data) has been entered.
Entry Started — Retrieves all CRFs that have an entry started status. RDC Onsite assigns this status to a CRF when data entry has been started but is not complete. For CRFs that are assigned this status, some required data fields are complete, while some are not. The CRF has been saved as incomplete.
Entry Complete — Retrieves all CRFs that have an entry complete status. RDC Onsite assigns this status to a CRF when all required fields have been entered, including data in the CRF header data and response data to CRF questions.
Pass2 Started — Retrieves all CRFs that have a pass2 started status. RDC Onsite assigns this status to a CRF that originated in the Oracle Clinical data entry system. This status indicates that the CRF requires a two-pass data entry and that at least one response has been recorded in the second pass.
Pass2 Complete — Retrieves all CRFs that have a pass2 complete status. RDC Onsite assigns this status to a CRF that originated in the Oracle Clinical data entry system. This status indicates that the CRF required a two-pass data entry and that the second pass is complete.
Entry or Pass2 Complete — Retrieves all CRFs that have either an entry complete status or a pass2 complete status.
Batch Loaded — Retrieves all CRFs that have a batch loaded status. RDC Onsite assigns this status to CRFs with response data that is entered by electronic means, not by users performing manual data entry.

Parent topic: Using CRF Status Search Criteria

Searching by CRF Discrepancy Status

Use the CRF Discrepancy Status parameter to retrieve all CRFs with a specific discrepancy status.

On the Patient Casebooks page, the Review CRFs page, and the Review Investigator Comments page, the discrepancy status is a CRF-level search parameter.

On the Home page, the discrepancy status a patient-level search parameter. For more information, see Searching for Patients by the Patient Discrepancy Status.

Valid values are:

All — Retrieves all CRFs regardless of discrepancy status. All is the default value.
Active — Retrieves CRFs with any active discrepancies; does not retrieve CRFs that have only hidden discrepancies. Active discrepancies are those discrepancies that are assigned to you or your user role for action.
On the Review Discrepancies page, Active does not retrieve hidden discrepancies.
Other — Retrieves CRFs with other discrepancies; does not retrieve CRFs that have only hidden discrepancies. Other discrepancies are those discrepancies that are assigned to another user role for action.
On the Review Discrepancies page, Other does not retrieve hidden discrepancies.
Open (Active & Other) — Retrieves CRFs with active or other discrepancies; does not retrieve CRFs that have only hidden discrepancies.

On the Review Discrepancies page, Open does not retrieve hidden discrepancies.

Note:
If you select Active, Other, or Open, the search does not retrieve CRFs that have only hidden discrepancies. For example, if a CRF has a hidden manual field discrepancy and an active univariate discrepancy, then the search retrieves the CRF. However, if the CRF has only a hidden manual field discrepancy, then the search does not retrieve the CRF.
Clean (None or Closed) — Retrieves CRFs with no discrepancies or with closed discrepancies, as well as CRFs that have only hidden discrepancies.

On the Review Discrepancies page, Clean is replaced by Closed. If you select Closed, the search does not retrieve hidden closed discrepancies.

For example, if the discrepancy is closed and hidden to your user role, the search does not retrieve the CRF.

Parent topic: Using CRF Status Search Criteria

Searching by a Custom Review Status

This search is available if any custom review types have been configured for your site and you have privileges to one or more of those review types.

If you have privileges to multiple review types, you select the review type you are working on, then select a status for that type of review.

Review Completed — Retrieves CRFs that were reviewed for all your review types.
Explicitly set RN status — Retrieves the CRFs for which a user marked the review as not required for any of your review types.
Review Required — Retrieves the CRFs for which the review is required for at least one of your review types.
Awaiting Re-review — Retrieves the CRFs that await re-review for at least one of your review types.

Parent topic: Using CRF Status Search Criteria

Searching by CRF Approval Status

This filter is available only if you have the BROWSE_VERIFY privilege or higher. Use the CRF Approval Status parameter to search for CRFs based on their current state of approval.

Valid values are:

All — Retrieves all CRFs regardless of their approval status. All is the default value.
Not Approved — Retrieves only CRFs that have never been approved.
Approved — Retrieves all CRFs with an approved status. This status indicates a user with approve privileges certified that the CRF is an accurate representation of the source data. In RDC Onsite, an approval is equivalent to an electronic signature.
Awaiting Re-Approval — Retrieves all CRFs with an awaiting re-approval status. This status indicates the CRF was approved, but one or more response values were updated since the approval. For CRFs with this status, users with approve privileges can choose to re-approve the CRF or undo the approval. Changes that cause RDC Onsite to reassign the approval status include:
- A response value updated
- A discrepancy updated or added
- An investigator comment updated or added
Approval Undone — Retrieves all CRFs with an approval undone status. This status indicates a user with approve privileges used the Undo Approval option to remove the approved status of a CRF.

Parent topic: Using CRF Status Search Criteria

Searching by CRF Verification Status

Use the CRF Verification Status parameter to search for CRFs based on their current state of verification. This search filter is available only if you have the BROWSE_VERIFY privilege or higher.

Valid values are:

All — Retrieves all CRFs regardless of their verification status. All is the default value.
Requires Verification — If partial source data verification is being used, retrieves only CRFs that require verification according to the patient SDV plan.
Verified — Retrieves all CRFs with a verified status. This status indicates a user with verify privileges checked the data in the CRF against the source data.
Awaiting Re-Verification — Retrieves all CRFs with an awaiting re-verification status. This status indicates the CRF was verified, but one or more response values were updated since the verification. For CRFs with this status, users with verify privileges can choose to re-verify the CRF or undo the verification. Changes that cause RDC Onsite to reassign the verification status include:
- A response value updated
- A discrepancy updated or added
- An investigator comment updated or added
Verification Undone — Retrieves all CRFs with a verification undone status. This status indicates the CRF was verified but subsequently the verification was undone. This status is equivalent to the Requires Verification status with the exception that a verification history exists for a CRF with a verification undone status.

Parent topic: Using CRF Status Search Criteria