Oracle Clinical

1. What is RDC?
Remote Data Capture (RDC) is a Web-based tool used at Investigator Sites to record, store
and manage clinical study data.
This process allows for Investigator Site and Sponsors to view clinical data directly in the
sponsors Oracle Clinical database at time of entry, address any discrepant data as needed and
sign or approve electronic case report forms.

2. What is Second Pass Entry? Is Second Pass Entry possible in RDC?

Second-pass data entry ensures that the data entered during the first-pass was entered
correctly and verifies that it agrees with the CRF. If the study specifies that second-pass data
entry is required the data is not accessible until second-pass entry is complete.
Second Pass Entry is not possible in RDC.

3. What is Comparison Reconciliation?

We will perform Comparison Reconciliation to resolve the differences between First pass
entry and second pass entry.

4. What is Batch Validation and Executing single Procedure?

The Batch Validation job checks data in a single study for all types of discrepancies. Most
organizations set up Batch Validation to run at regular intervals, usually nightly.

To see the total number of current discrepancies generated in the study by a single Procedure,
execute the Procedure explicitly; from the Conduct menu, select Data Validation, then select
Execute Single Procedure

5. Define DCF and what is the purpose of DCF?

A Data Clarification Form or Data Query Form is a questionnaire. The DCF is the
primary data clarification tool from CDM or Contract Research Organization (CRO) towards
the investigator to clarify discrepancies and ask the investigator for clarification.

6. Difference between database lock and freeze?

After response data has been reviewed and cleaned, you may want to ensure that no one
makes changes to it unless explicitly authorized. You may also want to prevent any new data
from being entered for a particular study or study site, or by a particular Investigator. Oracle
Clinical includes two related mechanisms for data security: Freezing and Locking.
Locking prevents changes to previously collected data except by users with privileged
update. You can lock data collected in a particular RDCM or RDCI, or lock all data for which
a particular Investigator is responsible in a single study, or all data in a study site, or all data
for a range of patients or individual patient, or for a single event, DCI, or data accessibility
date range. After data has been locked, it cannot be unlocked. However, users with privileged
update can modify locked data in Update or any other mode.

Freezing data prevents any further data from being entered for the unit frozen, and also locks
data already collected for the unit. You can freeze data by the following units: study,
Investigator, study site, patient range, or individual patient. When you freeze a study, the
system also freezes sites and patients for the study. Frozen units can be unfrozen by users
with the necessary privileges

7. What are univariate and multivariate discrepancies?

Univariate Discrepancies are related to single field/DCM. Univariate discrepancies may or

may not be batch dependent. In OC, univariate discrepancies are flagged as online
discrepancies. In other words, univariate discrepancies are the ones which fire from a single
variable.
Multivariate Discrepancies are the ones which fires cross comparing two or multiple fields.
These discrepancies are always batch dependent. In OC, multivariate discrepancies are
flagged as Offline discrepancies. In other words, multivariate discrepancies are the ones
which fire cross comparing two variables. These will be generated as result of executing the
procedures.

8. What are Patient Positions and what are the ways to create the patient positions?

Patient positions are codes that represent the people you enroll in a study. They are used as
the unique ID for patients enrolled in a study. You can create patient position codes in two
ways 1. Creating Patient Positions with System-Generated Codes 2. Creating Patient
Positions with User-Defined Codes

9. What is the hierarchy of the CRF Design in Oracle Clinical?

Oracle Clinical Questions correspond to the Questions on a CRF for a patient visit. You must
define an Oracle Clinical Question for each Question on a CRF.
In the Oracle Clinical Global Library, you can create Question Groups that contain multiple
logically related Questions to be collected in the same section of a CRF. You then create
DCMs (Data Collection Modules) that contain multiple logically related Question Groups to
be collected together. You can create DCIs (Data Collection Instruments) that contain
multiple logically related DCMs. In general, a DCI corresponds to a CRF.

10. Difference between Browse and Full modes?

Many modules have both a full privileges mode — where you can change data — and
browse or query-only mode — where you can view existing data but you cannot change it.
For example, you can create, update, and delete studies, if you have full privileges to the
Maintain Clinical Studies form.
If you have browse mode access, you can view the study records by navigating to the Qry
Clinical Studies menu but you cannot change them. Your organization determines your
access.

11. What is DVG and Types of DVG?

DVG is Discrete Value Group. It is set of valid responses to a question and Used when a list
of choices is offered on the CRF. It is Created and assigned to a question at the Glib(Global
Libary) level

There are 3 types of DVGs:

 Internal DVGs
 Alpha DVGs
 Thesaurus DVGs

12. How can you view the data and Update the data?

We can view the data in Browse window from data entry subsystem and we can view and
update the data in Update window from Data entry subsystem

13. What are the CPEs?

A clinical planned event (CPE) usually corresponds to a visit. You can also define a CPE for
the purpose of associating it with DCIs (corresponding to CRFs) that you want to have
available in a DCI Book without associating them with a particular visit, such as AEs or
ConMeds.

14. What are the levels of accessibility in the data entry process?

Oracle Clinical assigns a status to each DCI, which indicates its stage in the data entry
process. The system displays the status each time you open the DCI. There are three "levels"
of accessibility:

 Not accessible
 Internally accessible
 Externally accessible

15. What are Validation procedure and Derivation procedures?

Validation and Derivation Procedures serve two different purposes. Validation Procedures
 compare multiple Question responses for the same patient for the purpose of ensuring that
patient data is valid.
Derivation Procedures use calculations to derive values from collected data. However, both
types of Procedures are defined the same way, have the same internal structure, and are
executed during batch validation.

16. What is User Acceptance Testing (UAT)?

After finalizing the protocol, DM starts with the CRF preparation. After CRF being finalized,
Data Management will start building the database using the CDMS (like Oracle Clinical)

Database is the exact replica of the CRF pages. Once the database design is over, then Data
Management tests the database for User Acceptance, which is called User Acceptance Testing
(UAT).