4 Configuring the Mass Changes Utility

Setting up the Mass Change Utility (MCU), which is described in Oracle Clinical Conducting a Study, requires performing the following general steps, each described in the following sections:

4.1 Creating and Assigning Mass Changes Roles

Oracle Clinical supplies two default database roles for the Mass Changes Utility:

  • RXC_MC

  • RXC_MC_TEST

RXC_MC has access to all production mass change options and RXC_MC_TEST has access to the test mass change options only. Your organization can also choose to create your own roles.

Assign these roles to the users that work with the Mass Changes Utility.

4.2 Customizing Mass Changes Local Codelists

The Mass Changes Utility uses the local reference codelists described in the following table. You can modify them to suit your organization's needs. The affected tablename.columnname column indicates the database columns that are affected by or use each reference codelist. From the Admin menu, select Reference Codelists, then select Local Codelists and query the codelists named in the following table.

Table 4-1 Mass Changes Utility Reference Codelists

Name Description Affected Tablename.Columnname

MC CDS SORT ORDERFoot 1 

Default sort order for viewing and applying the candidate data set (CDS); the columns you can order.

mass_changes.order_by_cols

MC COLUMNSFoot 2 

The list of columns that can be used in LHS or RHS of criteria, such as RDCI.SITE

mass_change_criteria.col
mass_change_criteria.value

DISC COLS2

Columns available for the LHS and RHS of the CDS Criteria form, regardless of the discrepancy type specified, such as DE.CREATION_TS

mass_change_criteria.col
mass_change_criteria.value

UNI DISC COLS2

Columns available for the LHS and RHS of the CDS Criteria form, where the discrepancy type specified is UNIVARIATE, such as DE.DISCREPANCY_TYPE_CODE

mass_change_criteria.col
mass_change_criteria.value

IND DISC COLS2

Columns available for the LHS and RHS of the CDS Criteria form, where the discrepancy type specified is INDICATOR

mass_change_criteria.col
mass_change_criteria.value

MULTI DISC COLS2

Columns available for the LHS and RHS of the CDS Criteria form, where the discrepancy type specified is MULTIVARIATE, such as PROCEDURES.NAME

mass_change_criteria.col
mass_change_criteria.value

MANHD DISC COLS2

Columns available for the LHS and RHS of the CDS Criteria form, where the discrepancy type specified is MANUAL HEADER

mass_change_criteria.col
mass_change_criteria.value

FLD RXCMCMCD RDCI KEY

Candidate Data Set fields to be displayed on the Candidate Data Set form when called for RDCI KEY changes, their order of display, width, and prompt.

N/A

FLD RXCMCMCD RDCM KEY

Candidate Data Set fields to be displayed on the Candidate Data Set form when called for RDCM KEY changes, their order of display, width, and prompt

N/A

FLD RXCMCMCD RDCI DELETE

Candidate Data Set fields to be displayed on the Candidate Data Set form when called for RDCI DELETE changes, their order of display, width, and prompt

N/A

FLD RXCMCMCD RESPONSE

Candidate Data Set fields to be displayed on the Candidate Data Set form when called for Responses changes, their order of display, width, and prompt

N/A

OCL MC PREFSFoot 3 

Sets the default maximum number of records to change in a Candidate Data Set. Its initial long value is 1000.

mass_changes.max_cds_records


Footnote 1 Only the display sequence and whether the field should be sorted in ascending or descending order should be changed. New fields should not be added and existing ones should not be removed.

Footnote 2 The values in this reference codelist determine the contents of the list of values for mass change criteria. Additional values may be added to the reference codelist but they must be from one of the existing tables already defined for values, and they must use the alias provided for the table. No validation occurs against the values in this codelist. If a value is not in the list of values it can still be added as a criterion for specifying the candidate data set.

Footnote 3 OCL MC PREFS currently has one value, MAX_CDS_RECORDS, which controls the default maximum number of records to include in a Candidate Data Set.

4.3 Customizing the Field Display on the Candidate Data Set Form

These local codelists control the display of fields on the Candidate Data Set form for the four Mass Changes Utility change types:

  • FLD RXCMCMCD RDCI KEY

  • FLD RXCMCMCD RDCM KEY

  • FLD RXCMCMCD RDCI DELETE

  • FLD RXCMCMCD RESPONSE

From the Admin menu, select Reference Codelists, then select  Local Codelists, and query FLD% in the Name field. The following table describes how the codelist values control all four codelists:

Table 4-2 CDS Display Codelist Fields

Codelist Field Name Description

Seq

Sequence number: Orders each value's column position in either the fixed (the lowest numbers), or scrolling sections of the Mass Changes Utility form. (See Description, below)

Short Value

The name of the field in the form. You must not change these values.

Long Value

The display length for the field on the Candidate Data Set form.

Active box

Check a value's Active box to display to include its field on the Mass Changes Utility form.

Default box

N/A

Description

The value's assignment to the non-scrolling or scrolling sections of the Mass Changes Utility form, and its prompt label. The description field has the following syntax:

F:promptlabel
or
S:promptlabel

Where:
F: locates the field in the left-side, non-scrolling section of the Candidate Data Set form.

S: locates the field on the scrolling, right-side section of the Candidate Data Set form.

promptlabel The field label on the Candidate Data Set form.

If all fields are non-scrolling, you must still use the F:promptlabel syntax.

For Response data and data comment fields, the prompt is the default prompt for the DCM question concatenated with promptlabel.


Oracle Clinical has default values for these codelists that reflect the most likely scenario for displaying the Candidate Data Set. You can modify the default values. Table 4-4, "Candidate Data Set Form Codelist Values" lists all possible column values. You can add, remove, modify, or rearrange the display fields. Footnotes follow that table.

The following table is a legend for the values in Table 4-4, "Candidate Data Set Form Codelist Values".

Table 4-3 Legend for Table 4-4, "Candidate Data Set Form Codelist Values"

Symbol Description

~

A tilde (~) indicates that the value does not qualify for any of the change types.

Ι

RDCI KEY change type

D

RDCI DELETE change type

M

RDCM KEY change type

R

RESPONSE change type

All

Applies to all change type codes: RDCI KEY, RDCI DELETE, RDCM KEY, RESPONSE

*

The system does not display this field. Instead a display field is used as with the Data Entry Log-in form. This field displays the data retrieved into the base table field in the appropriate format and translates the information entered into the new fields to the format needed by the base table fields. This field contains an list of values, or is update-able, pertains to the display field, with the update of the base table fields by the system. It is necessary for the reference codelist to have the display fields rather than the base table field. For these fields, the labels, Column value refers to the base table field and short name refers to the display field.

**

The clin_plan_eve_name_new field list of values contains the visit number as well, for reference purposes only.

Responses and associated old and new values are required and present by default, if they exist.

An list of values is present for exception_value_text if an alpha data code discrete value group exists for the DCM question, and values from this group are part of the list of values.

Ñ

An list of values is present for value_text if a discrete value group exists for the DCM question, and values from this group will appear in the list of values

½

There is an list of values for the full_value_text if any discrete value group exists for the DCM question, and values from these groups appear in the list of values.


Table 4-4 Candidate Data Set Form Codelist Values

Column Value Short Name Display Settings by Mass Changes Utility Change Type
Recom-
mended
Set by Default Can be Set List of Values Update-able

cdr_status_code

cdr_status_code

All

All

     

validate_comment

val_comment

All

All

     

change_reason_codeFoot 1 

(Must be valid in codelist)

c_reason_code

All

All

 

All

All

audit_comment

audit_comment

All

All

   

All

how_updated

how_updated

I, M, R

I, M, R

     

received_dci_id

received_dci_id

   

All

   

document_number

doc_number

All

All

     

document_number_new

doc_number_new

I

I

   

I

investigator

investig

I

All

     

investigator_new

investig_new

I

I

 

I

I

site

site

I

All

~

~

~

site_new

site_new

I

I

~

I

I

patient

patient

I

All

~

~

~

patient_new

patient_new

I

I

~

I

I

dci_short_name

dci_sh_name

I

All

~

~

~

dci_short_name_new

dci_sh_name_new

I

I

~

I

I

clin_plan_eve_name

cpe_name

I

All

~

~

~

clin_plan_eve_name_new

cpe_name_new

I

I, M

~

I, M**

I, M

visit_number

vis_number

I

All

~

~

~

subevent_number

sub_number

I

All

~

~

~

subevent_number_new

sub_number_new

I

All

~

I, M

I, M

dci_date*

dci_dt

I

I, D, M

R

~

~

dci_date_new*

dci_dt_new

I

I

~

~

I

dci_time*

dci_tm

I

I, D, M

R

~

~

dci_time_new*

dci_tm_new

I

I

~

~

I

comment_text

cm_txt

I, M

I, D, M

R

~

~

comment_text_new

cm_txt_new

I, M

I, M

~

~

I, M

blank_flag

blank_flag

I, M

I, D, M

R

~

~

blank_flag_new

blank_flag_new

I, M

I, M

 

I, M

I, M

received_dcm_id

received_dcm_id

~

~

M, R

~

~

rdci_clin_plan_eve_name

rdci_cpe_name

~

~

M, R

~

~

rdci_visit_number

rdci_vis_number

~

~

M, R

~

~

rdci_subevent_number

rdci_sub_number

~

~

M, R

~

~

rdci_comment_text

rdci_cm_txt

~

~

M, R

~

~

rdci_blank_flag

rdci_blank_flag

~

~

M, R

~

~

dcm_name

dcm_name

M

M, R

~

~

~

dcm_subset_name

dcm_subset_name

~

M

R

~

~

dcm_layout_sn

dcm_layout_sn

~

M

R

~

~

dcm_date*

dcm_dt

M

M

R

~

~

dcm_date_new*

dcm_dt_new

M

M

~

~

M

dcm_time*

dcm_tm

M

M

R

~

~

dcm_time_new*

dcm_tm_new

M

M

~

~

M

qualifying_value

qual_value

M

M, R

~

~

~

qualifying_value_new

qual_value_new

M

M

~

M

M

data_comment_text

dta_cm_txt

M

M

R

~

~

data_comment_text_new

dta_cm_txt_new

M

M

R

~

M

repeat_sn

repeat_sn

R

R

~

~

~

response_id1

response_id1

~

~

R

~

~

validation_status1

valid_status1

~

R

~

~

~

exception_value_text1

e_val_txt1

~

~

R

R‡

~

value_text1

val_txt1

~

~

R

RÑ

~

full_value_text1

f_val_txt1

R

R

~

R½

~

full_value_text1_newFoot 2 

f_val_txt1_new

R

R

~

R½

R

data_comment_text1

dta_cm_txt1

R

R

~

~

~

data_comment_text1_new

dta_cm_txt1_new

R

R

~

~

R

response_id2

response_id2

~

~

R

~

~

validation_status2

valid_status2

~

R

~

~

~

exception_value_text2

e_val_txt2

~

~

R

R‡

~

value_text2

val_txt2

~

~

R

RÑ

~

full_value_text2

f_val_txt2

R†

R†

~

R½

~

full_value_text2_new2

f_val_txt2_new

R†

R†

~

R½, as per data entry

R

data_comment_text2

dta_cm_txt2

R†

R†

~

~

~

data_comment_text2_new

dta_cm_txt2_new

R†

R†

~

~

R

response_id3

response_id3

~

~

R

~

~

validation_status3

valid_status3

~

R

~

~

~

exception_value_text3

e_val_txt3

~

~

R

R‡

~

value_text3

val_txt3

~

~

R

RÑ

~

full_value_text3

f_val_txt3

R†

R†

~

R½

~

full_value_text3_new

f_val_txt3_new

R†

R†

~

R½, as per data entry

R

data_comment_text3

dta_cm_txt3

R†

R†

~

~

~

data_comment_text3_new

dta_cm_txt3_new

R†

R†

~

~

R

response_id4

response_id4

~

~

R

~

~

validation_status4

valid_status4

~

R

~

~

~

exception_value_text4

e_val_txt4

~

~

R

R‡

~

value_text4

val_txt4

~

~

R

RÑ

~

full_value_text4

f_val_txt4

R†

R†

~

R½

~

full_value_text4_new

f_val_txt4_new

R†

R†

~

R½, as per data entry

R

data_comment_text4

dta_cm_txt4

R†

R†

~

~

~

data_comment_text4_new

dta_cm_txt4_new

R†

R†

~

~

R


Footnote 1 Validation issue: Value must be valid in the reference code list.

Footnote 2 Validation issue: Must pass field validation in data entry.