A Description of the CRF Icons

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:

Data Entry Status Icons
Discrepancy Status Icons
Verification Status Icons
Approval Status Icons
Custom Review Status Icons
Multiple-Status Icons
Summary of Colors and Symbols Added to CRF Icons

Data Entry Status Icons

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.

Discrepancy Status Icons

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.

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.

Verification Status Icons

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.

Approval Status Icons

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.

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.

Custom Review Status Icons

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 (or not required) 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.
	RR: At least one of your reviews was reversed due to data update and it's awaiting re-review.

Multiple-Status Icons

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: Has been batch loaded (disk) Has been approved (signature) Is awaiting re-verification (red arrow next to check mark) Is locked (padlock) This is a sponsor operation, but might reflect in an activity that shows records with this status.
	Indicates the CRF: Has data entry completed (form with fields) Has one or more active discrepancies (red background) Has been verified (check mark) Has been approved (signature)
	Indicates the CRF: Has had a second pass of data entry (form with the number 2) Has one or more active discrepancies (red background) Is awaiting re-verification (red arrow next to check mark) Is awaiting re-approval (red arrow next to signature) This record originates from an Oracle Clinical operation, but your sponsor might create an activity that shows records with this status.
	Indicates the CRF: Has data entry completed (form with fields) Has one or more other discrepancies (yellow background) Has been verified (check mark) Is awaiting re-approval (red arrow next to signature) Is locked (padlock) This record originates from an Oracle Clinical operation, but your sponsor might create an activity that shows records with this status.

Summary of Colors and Symbols Added to CRF Icons

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	Description of the illustration crf_nr_1_od_nv_na_nl.gif	Has one or more other discrepancies that must be addressed by a user in a role other than yours.
White color	White color	Description of the illustration crf_nr_1_nd_nv_na_nl.gif	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	Description of the illustration crf_nr_1_nd_v_na_nl.gif	Has been verified (that is, checked).
Description of the illustration icon_crf_ver_cmarka.gif	Red arrow next to the check mark	Description of the illustration crf_nr_1_nd_rv_a_nl.gif	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.
Description of the illustration icon_crf_appr_sign.gif	Signature added to bottom of icon	Description of the illustration crf_nr_1s_nd_nv_a_nl.gif	Has been approved.
Description of the illustration icon_crf_appr_sarrow.gif	Red arrow next to the signature	Description of the illustration crf_nr_1_nd_nv_ra_nl.gif	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	Description of the illustration rdc_nr_1s_od_v_ra_l.gif	Is locked.