Setting Up Data Clarification Forms (DCFs)

Oracle Clinical includes a utility for printing and tracking Data Clarification Forms (DCFs) as a way of resolving discrepancies in a clinical trial's response data. Setting up DCFs for your organization requires that you define DCF status codes and lay out the DCF report.

For more information, see:

Parent topic: Configuring Discrepancy Management

Defining DCF Statuses and their Behavior

There are several Installation Reference Codelists that affect DCF Statuses. You can modify them to for your organization's needs. See the following:

Parent topic: Setting Up Data Clarification Forms (DCFs)

DCF STATUS CODES

The DCF Status reflects the stage in the review process of the DCF as a whole. Oracle Clinical comes with many review statuses defined in this reference codelist. You can make them inactive if you do not want to use them or create new ones, with the following limitations:

You cannot make these statuses inactive: Sent, Received, and Closed.
Do not make status Created inactive unless you also make it optional in the DCF OPTIONAL STATUS CODES reference codelist.
Do not make statuses Incomplete, Part Received, or Received inactive if you want the system to automatically update the DCF Status when users update the status of individual DCF Pages.
If you add a status, you must set its DISPLAY_SN, which determines the order in which the statuses can be set. If you adjust the DISPLAY_SN, you may need to adjust the DCF LOCK CONDITIONS and the DCF OPTIONAL STATUS CODES installation reference codelists, both of which refer to DCF Statuses by their number in the DCF STATUS CODES installation reference codelist.

Parent topic: Defining DCF Statuses and their Behavior

DCF OPTIONAL STATUS CODES

This installation reference codelist refers to the DCF Statuses listed in the DCF STATUS CODES reference codelist. The number in the Short Value column refers to the display number of the status in the DCF STATUS CODES codelist. (Note that the description is incorrect for numbers 7 and 8, which should be Incomplete and Part Received.)

All status codes referenced and active in this codelist are optional. All that are inactive or not entered here are mandatory, meaning that a DCF must be assigned to that status before it can be assigned a subsequent status, as defined in the Seq column. As shipped, only CREATED, SENT and CLOSED are mandatory (no rows exist with short values 2, 6, or 12).

To make a status mandatory if it is included in this reference codelist, uncheck its Active box.

Parent topic: Defining DCF Statuses and their Behavior

DCF LOCK CONDITIONS

This installation reference codelist determines what actions can be taken on discrepancies and DCFs where the DCF has a particular status. The Long Value refers to the number of the status in the DCF STATUS CODES codelist. As shipped, the codelist sets the following behavior, in order:

Discrepancies belonging to a DCF whose status is Final (#4) or higher cannot be deleted.
Discrepancies belonging to a DCF whose status is Ready (#5) or higher cannot be modified.
DCFs whose status is Ready (#5) or higher cannot be deleted (unless the status exceeds or equals a status with a DISPLAY_SN of 1000; see last point).
DCFs whose status is Ready (#5) or higher cannot be modified.
DCFs whose status is #1000 or higher cannot be closed. Oracle recommends that you do not change DCF_CLOSE.

To stop enforcing any of these rules, set the Long Value to a high value. To change the DCF Status that prevents any of the actions described in the Short Value column, change the number in the Long Value column to the number in the DCF STATUS CODES codelist of the status you prefer.

Parent topic: Defining DCF Statuses and their Behavior

Laying Out the DCF

OPA views dcf_rpt_master and dcf_rpt_detail control much of the content and the appearance of DCFs. Local codelist DCF REPORT LABELS controls the report's label text. DCFs also include several unchangeable parameters, such as the Revision # and other values that print along the bottom of each DCF page.

For laying out the DCF's contents and arranging its fields, and view a geographic representation of the DCF's default values and their placements, see:

Parent topic: Setting Up Data Clarification Forms (DCFs)

Replacing the DCF Placeholder Graphic

Oracle Clinical includes a placeholder graphic file located, typically, in your installation's ..\OPArelease_number\oc directory, and named rxcdcf.bmp. You can replace rxcdcf.bmp with your own graphic file, but you must name it rxcdcf.bmp. Oracle recommends that your graphic does not exceed 200 pixels in height.

Parent topic: Laying Out the DCF

Modifying Codelist DCF REPORT LABELS

The labels for the value fields of the DCF views correspond to their position on the report. The following table describes each of the columns on the report. For field labels, it identifies the codelist member in the DCF REPORT LABELS local codelist and their default table and column values.

Table 3-24 DCF Labels and Field Mappings

Default Field Label from DCF_REPORT_LABELS Short Value	Default Field Label from DCF_REPORT_LABELS Long Value	Default Data Value from DCF_RPT_MASTER and DCF_RPT_DETAIL Table.Column	Default Data Value from DCF_RPT_MASTER and DCF_RPT_DETAIL Description
line1_left	To:	ocl_sites.name	Site name's short value
line3_left	Date:	sysdate	Date of this DCF's creation: mm/dd/yyyy
line3_right	Reviewer	oracle_accounts.firstname (and) .lastname	Reviewer's initials
line2_left	Investigator:	ocl_investigators.first_name (and) .lastname	Investigator's first and last name.
line1_right	Patient #:	patient_positions.patient	Patient position
line2_right	Patient Initials:	patient_positions.reported_first_name (and) .reported_last_name	Patient's initials
q_field1	Form Name/Visit Name:	dcms.description	Mapped to view value qline1_1
q_field2	Page #:	discrepancy_entries.crf_page_number	CRF page numberMapped to view value qline1_2
q_field3	Date:	discrepancy_entries.creation_ts	Discrepancy time stamp date: mm/dd/yyyyMapped to view value qline1_3
q_field4	Questions/Comments:	dcf_discrepancies.comment_text	Mapped to view value qline1_4
q_field5	Resolution:	dcf_discrepancies.resolution_text	Mapped to view value qline1_5
mstr_sort_order^Foot 1	line1_right	patient_positions.patient	Controls the default sort order of view DCF_RPT_MASTER
dtl_sort_order¹	q_line1_1	dcm.description	Controls the default sort order of view DCF_RPT_DETAIL
rpt_orientation¹	`Landscape`	-	Landscape or Portrait Controls the default action of the Print button in the DCF form.

^Footnote 1

Not a label

Parent topic: Laying Out the DCF

Modifying the DCF Views

The following tables describe all of the parameters in the two DCF report views. The view scripts for the DCF are in file rxcviews.sql. You can map other discrepancy values to the DCF parameters, or comment out the parameters to remove them from the DCF output. Note that if you remap parameters, you may have to change their labels (See Modifying Codelist DCF REPORT LABELS.)

Caution:

Do not change parameter values that have a _DNC suffix.

Table 3-25 View DCF_RPT_MASTER Parameters

Parameter	Default Data Value (Table.Column)	Comments
dcf_id_dnc	data_clarification_forms.dcf_id	A system-generated number.
title1	clinical_studies.short_title	Prints the study's title.
title2	'Data Clarification Form'	Prints the text string Discrepancy Clarification Form.
line1_left	ocl_sites.name	Site name's short value
line3_left	sysdate	Date of this DCF's creation: MM/DD/YYYY
line3_right	oracle_accounts.firstname and .lastname	DCF creator's account name
line2_left	ocl_investigators.first_name (and) .lastname	Investigator's first and last name.
line1_right	patient_positions.patient	Patient position
line2_right	patient_positions.reported_first_name (and) reported_last_name	Patient's initials
header_text	header_text	Prints the discrepancy's header text. Define header text in the Standard Text Maintenance form.
footer_text	footer_text	Prints the discrepancy's footer text. Define footer text in the Standard Text Maintenance form
clinical_study_id_dnc	clinical_studies.clinical_study_id	-
current_status_dnc	data_clarification_forms.current_status	-
site_id_dnc	data_clarification_forms.site_id	-
investigator_id_dnc	ocl_investigators.first_name (and) .last_name	Investigator's initials
owning_user_dnc	data_clarification_forms.owning_user	-

The following table describes the values of the DCF_RPT_DETAIL view, and its default data values. In DCF report printouts, the system draws a rectangular border around the output of this view, and may include more than one discrepancy's details.

Table 3-26 View DCF_RPT_DETAIL Parameters

View Parameter	Default Data Value (Table.Column)	Comments
dcf_id_dnc	data_clarification_forms.dcf_id	-
q_line1_1	dcms.description	Value for q_field1 label
q_line1_2	discrepancy_entries.crf_page_number	Value for q_field2 label
q_line1_3	received_dcms.dcm_date	Value for q_field3label
q_line1_4	dcf_discrepancies.comment_text	Value for q_field4label
q_line1_5	dcf_discrepancies.resolution_text	Value for q_field5label
q_line2_1	clinical_planned_events.description	-
discrepancy_entry_id_dnc	discrepancy_entries.discrepancy_entries	-
status_dnc	dcf_discrepancies.status	-
disc_type	discrepancy_entries.de_sub_type_code	-
disc_rev	discrepancy_entries.discrepancy_rev_status	-

Parent topic: Laying Out the DCF

Defining DCF Headers and Footers

You can define standard text headers and footers in the Standard Text Maintenance form (see Creating New Standard Text). You can define any number of standard headers and footers and designate one header and one footer as the default. When you create a DCF, the system assigns it the default header and footer. You can use the list of values in the Header and Footer fields to choose a different standard header or footer.

You can also modify the standard text of the header or footer by clicking the Text button in the main DCF screen and editing the displayed text.

Parent topic: Laying Out the DCF

Default DCF Layout Diagram

The following diagram shows the relative position of the labels (in bold font), and the default data values of a default DCF printout. The section between the rxcdcf.bmp graphic and the ruled rectangle contains most of the data defined in the DCF_RPT_MASTER view. The DCF_RPT_DETAIL view populates the contents in the rectangle. A DCF can accommodate the descriptions of more than one discrepancy on each page. The legend for the DCF layout diagram precedes the diagram itself.