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Oracle® Clinical Remote Data Capture Onsite Administrator's Guide
Release 4.6.2

Part Number E18823-01
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7 Working with the RDC Client Package

The RDC Client package contains PL*SQL procedures that you can modify to customize various aspects of how the RDC Onsite application behaves. For example, you can customize document numbers, set how often RDC Onsite requests user names and password for approvals, and customize bookmark labels for a Patient Data Report.

To make these custom changes, you only need to modify the procedures in the RDC package body for the client:

rdcpb_client.sql

Note:

Do not modify the RDC package specification for the client (rdcps_client.sql).

This chapter includes the following topics:

7.1 Deriving Company-Specific Document Numbers

Function Name: DeriveDocumentNumber
Purpose: Derives an identification number from the key fields of the document. Modify the code according to your business rules. For example, you may want to make the site number part of the document number.

The DeriveDocumentNumber function serves the same purpose as the DeriveDocumentNumber function in the Oracle Clinical package. If you customized code for the Oracle Clinical package, you can copy and paste that code into the RDC Client package.

Parameters: study (in varchar2) — Denotes the name of the study.

clinical_study_id (in number) — Denotes the ID number of the study.

patient (in varchar2) — Denotes the code name (external identifier) of the patient.

patient_position_id (in number) — Denotes the position number of the patient.

investigator (in varchar2) — Denotes the code name of the investigator.

investigator_id (in number) — Denotes the ID number of the investigator.

site (in varchar2) — Denotes the code name of the site.

site_id (in number) — Denotes the ID number of the site.

DCI (in varchar2) — Denotes the name of the data collection instrument (DCI).

dci_id (in number) — Denotes the ID number of the DCI.

event (in varchar2) — Denotes the name of the clinical planned event.

clin_plan_eve_id (in number) — Denotes the ID number of the clinical planned event.

subevent (in number) — Denotes the ID number of a subtype of the planned event.

rxc_env_type (in varchar2) — Denotes the environment type, where T indicates Test mode and P indicates Production mode.

Return Value: Returns the ID number as a varchar2. The default is a system-generated sequence number.
Default Logic: Returns "R" concatenated to the next value from sequence Received_dci_seq2.

7.2 Configuring a Timer Period for Subsequent Electronic Signatures

Function Name: htmlde_timeout_mins
Purpose: Sets the time period in minutes for when users performing approvals in RDC Onsite will need to re-enter their user name.

The first time a user attempts to approve a CRF in a session, RDC Onsite prompts for both a user name and a password. After the first approval, the defined time period starts. During the time period, the user can approve many CRFs. For these subsequent approvals, RDC Onsite prompts only for a password.

When the time period expires, RDC Onsite again prompts for both a user name and a password before approving the CRF. The time period then restarts. The user only needs to enter a password on subsequent approvals until the time period expires.

Parameters: None.
Return Value: Returns an integer that specifies the number of minutes for the time period.
Default Logic: 10 (that is, 10 minutes).

7.3 Configuring the DCI Bookmark Label for the Patient Data Report

Function Name: get_dci_label
Purpose: Lets you customize the label used for a DCI in the bookmark of the Patient Data Report.

By default, this function returns the name of the DCI. You may want to customize this function to return the short name or to use the unique dci_id to retrieve a label from another table or system.

Parameters: pDciId — Denotes the ID of the DCI.
Return Value: Returns the text that is displayed for a DCI in the bookmark of the Patient Data Report.
Default Logic: Returns the name of a DCI.
Related Functions: get_dcm_label

get_visit_label


7.4 Configuring the DCM Bookmark Label for the Patient Data Report

Function Name: get_dcm_label
Purpose: Lets you customize the label used for a DCM in the bookmark of the Patient Data Report. RDC Onsite calls this function only if the local database setting for the data domain is set to DCM.

By default, this function returns the name of the DCM. You may want to customize this function to return the description or to use the unique combination of dcm_id, dcm_subset_sn, dcm_layout_sn, and qualifying_value to retrieve a label from another table or system.

Parameters: pDcmId — Denotes the ID of the DCM.

pDcmSubset — Denotes the subset number of the DCM.

pDcmLayout — Denotes the layout number of the DCM.

pDcmQualVal — Denotes the qualifying value of the DCM.

Return Value: Returns the text that is displayed for a DCM in the bookmark of the Patient Data Report.
Default Logic: Returns the name of a DCM.
Related Functions: get_dci_label

get_visit_label


7.5 Configuring the Visit Bookmark Label for the Patient Data Report

Function Name: get_visit_label
Purpose: Lets you customize the label used for a visit in the bookmark of the Patient Data Report.

By default, this function returns the name of the visit (that is, the clinical planned event). You may want to customize this function to return the description, to return the phase, or to use the unique clin_planned_event_id to retrieve a label from another table or system.

Parameters: pClinPlanEveId — Denotes the ID of the clinical planned event.

pSubEventNo — Denotes the subevent number.

Return Value: Returns the text that is displayed for a visit in the bookmark of the Patient Data Report.
Default Logic: Returns the name of a visit.
Related Functions: get_dci_label

get_dcm_label