This appendix describes the CRF icons that appear on the Casebooks page and the Review pages in Oracle Clinical Remote Data Capture Onsite (RDC Onsite).
This appendix includes the following topics:
RDC Onsite uses colored icons with various symbols and graphics to represent the current status of each CRF. For example, by looking at a CRF icon, you can determine:
If data entry for the CRF has started, is complete, or is on a second pass
If the CRF has any active discrepancies or other discrepancies
If a custom review or re-review is required, not required, or completed
If the CRF has been verified or if it needs re-verification
If the CRF has been approved or if it needs re-approval
If the CRF is locked
RDC Onsite uses a series of icons to indicate the formal stages of data entry and to track the progression of a CRF from no data entered to entry complete.
Table A-1 describes the icons that RDC Onsite uses to indicate the various stages of data entry in a CRF.
Table A-1 Data Entry Status Icons
Icon | Label | Description |
---|---|---|
Placeholder |
No information has been entered into the CRF. |
|
Created |
All required header information has been entered and saved for the CRF. However, no response data has been entered yet. |
|
Blank |
A user has intentionally marked the CRF as blank. A blank CRF contains no data. You cannot enter data into a CRF while it is marked as blank. |
|
Entry Completed |
All required fields have been entered, including CRF header fields and responses to all data points. All required CRF header and section information is complete and at least one question area response field is completed. In addition, a CRF with this icon has no discrepancies, is not yet verified, and is not yet approved. RDC Onsite adds color and symbols to the Entry Complete icon to indicate discrepancy, verification, and approval status. |
|
Pass 2 Started |
The second pass of data entry has started. This record originates from an Oracle Clinical operation, but your sponsor might create an activity that displays records with this status. |
|
Pass 2 Completed |
The second pass of data entry is completed. This record originates from an Oracle Clinical operation, but your sponsor might create an activity that displays records with this status. |
|
Batch Loaded |
The data for the CRF was loaded during an automatic batch operation configured by your sponsor. The response values were entered into a CRF by electronic means, as opposed to manually entered by a user performing data entry. |
A discrepancy is any data that falls outside of an expected range of values or is otherwise flagged during the edit check process as an error. Table A-2 shows the discrepancy status icons.
The discrepancy status icons indicate whether you (or a member of your user group) or another group needs to correct some of the information in a CRF.
To indicate the status of discrepancies in a CRF, RDC Onsite adds the following color to the Entry Completed icon:
Red to indicate active discrepancies.
Yellow to indicates other discrepancies.
If a CRF contains both active discrepancies and other discrepancies, the icon remains red until you address all active discrepancies in the CRF. At that point, if one or more discrepancies with a status of other are still open, the icon changes from red to yellow. If a CRF has no discrepancies or if all discrepancies are closed, the icon is white.
Table A-2 Discrepancy Status Icons
Icon | Label | Description |
---|---|---|
Entry Completed (and no open discrepancies) |
There are no open discrepancies (active or other) associated with the CRF. There may, however, be closed discrepancies associated with the CRF. Note that this icon is the Entry Completed icon. RDC Onsite adds color to the Entry Completed icon to indicate the status of discrepancies. |
|
Active Discrepancies |
The red color added to the Entry Completed icon indicates that the CRF has one or more active discrepancies that must be addressed by you or by a member of your user group. |
|
Other Discrepancies |
The yellow color added to the Entry Completed icon indicates that the CRF has one or more other discrepancies that must be addressed by a user in a role other than yours. |
As shown in Table A-3, RDC Onsite adds symbols to the Entry Completed icon to indicate the verification status of a CRF. CRF Verification Status is only visible in the CRF icon if you have the appropriate privileges.
Table A-3 Verification Status Icons
Icon | Label | Description |
---|---|---|
Entry Completed (but not yet verified) |
The CRF has not been verified. Note that this icon is the Entry Completed icon. RDC Onsite adds symbols to the Entry Completed icon to indicate the verification status. |
|
Verified |
The check mark added to the Entry Completed icon indicates that the CRF has been verified (that is, checked). |
|
Awaiting Re-Verification |
Note that RDC Onsite adds a red arrow next to the check mark to indicate that the verification process must be repeated. The CRF is awaiting re-verification. At least one data point in the verified CRF has been modified since verification. The CRF must be verified again. |
|
Verification Required |
This icon is used only if partial source data verification is in effect. Otherwise, all CRFs are assumed to require verification. |
As shown in Table A-4, RDC Onsite adds signatures and symbols to the Entry Completed icon to indicate the approval status of a CRF.
Table A-4 Approval Status Icons
Icon | Label | Description |
---|---|---|
Entry Completed (but not yet approved) |
The CRF has not been approved. Note that this icon is the Entry Completed icon. RDC Onsite adds symbols to the Entry Completed icon to indicate the approval status. |
|
Approved |
The signature added to the Entry Completed icon indicates that the CRF has been approved. |
|
Awaiting Re-Approval |
The CRF is awaiting re-approval. At least one data point in the approved CRF has been modified since approval. The CRF must be approved again. Note that RDC Onsite adds a red arrow next to the signature to indicate that the approval process must be repeated. |
If your study has Custom Review Types defined, the status of a CRF can be one in the following Table A-6, depending on your privileges. You can have privileges for multiple review types.
Table A-5 Custom Review Status Icons
Icon | Description |
---|---|
RC: Review is complete for all your review types. |
|
RQ: Review for at least one of your review types is required. |
|
RN: The CRF does not require review for any of your review types. Only appears if the Review not Required (RN) status was applied by a user. It does not appear if the status was applied by custom review requirements. |
|
RR: At least one of your reviews was reversed due to data update and it's awaiting re-review. |
RDC Onsite adds color and graphics to the Entry Completed icon, the Pass 2 Completed icon, and the Batch Loaded icon to further indicate the status of a CRF.
Some CRFs can have more than one status. Table A-6 provides a few examples of CRF icons that have a combination of statuses.
Table A-6 Multiple-Status Icons
Icon | Description |
---|---|
Indicates the CRF:
This is a sponsor operation, but might reflect in an activity that shows records with this status. |
|
Indicates the CRF:
|
|
Indicates the CRF:
This record originates from an Oracle Clinical operation, but your sponsor might create an activity that shows records with this status. |
|
Indicates the CRF:
This record originates from an Oracle Clinical operation, but your sponsor might create an activity that shows records with this status. |
Table A-7 summarizes the colors and graphics that RDC Onsite adds to the Entry Completed icon, the Pass 2 Completed icon, and the Batch Loaded icon to further indicate the status of a CRF.
Table A-7 Graphical Elements that RDC Onsite Adds to the Basic CRF Icons
Added Graphic | Description of Added Graphic | Example of CRF Icon | Indicates that the CRF… |
---|---|---|---|
Red color |
Red color |
Description of the illustration ''crf_nr_1_d_nv_na_nl.gif'' |
Has one or more active discrepancies that must be addressed by you or by a member of your user group. |
Yellow color |
Yellow color |
|
Has one or more other discrepancies that must be addressed by a user in a role other than yours. |
White color |
White color |
|
Has no open discrepancies (active or other). There may, however, be closed discrepancies associated with the CRF. |
Description of the illustration ''icon_crf_ver_cmark.gif'' |
Check mark |
Has been verified (that is, checked). |
|
Red arrow next to the check mark |
Is awaiting re-verification. At least one data point in the verified CRF has been modified since the last verification. The CRF must be verified again. |
||
Signature added to bottom of icon |
|
Has been approved. |
|
|
Red arrow next to the signature |
|
Is awaiting re-approval. At least one data point in the approved CRF has been modified since the last approval. The CRF must be approved again. |
Description of the illustration ''icon_crf_lock.gif'' |
Padlock |
Is locked. |