Oracle® Clinical Conducting a Study Release 5.1 E53564-01 |
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Oracle Clinical provides several utilities for keeping account of all patient data expected during the course of a study, and for cleaning it once it is in the system.
This chapter contains the following topics:
Based on a schedule established during study design Oracle Clinical creates an internal schedule of expected visits — clinical planned events (CPEs) — and their associated Data Collection Modules (DCMs; groups of related questions), and checks if the expected responses to them arrive as planned. You can access this information through the Maintain Missing DCMs window in the Data Entry menu.
Oracle Clinical's DCM tracking process makes it possible to:
Track detailed DCM activity for a given patient within a specified time, ranging from past visits to planned future visits.
Control the reporting of DCMs that have optional and early termination visits.
Use the study's CPE schedule to project dates for Missing and Expected DCMs.
Focus on Missing and Overdue DCMs for studies, sites, patients, and visits.
To use the DCM tracking features effectively, it helps to understand some parts of how Oracle Clinical works internally.
This section explains the following:
Oracle Clinical forecasts expected data from the study schedule. The study schedule is created during the following activities:
During study design, you establish the number of Clinical Planned Events (CPEs, usually patient visits), and the intervals between them. When you set up the CPE schedule, you enter offsets between visits or offsets from the beginning of an interval to indicate when visits should take place. (See Oracle Clinical Creating a Study for more information.)
During study data definition, after you have created DCMs and DCM subsets, you define them as Expected or Optional against the CPEs in the DCM Schedule window. In other words, DCMs are created and then mapped to the visit schedule. (See Oracle Clinical Creating a Study for more information.)
Putting together the CPE schedule, DCMs and DCM subsets, DCM schedule, and the data that has actually been received, Oracle Clinical determines visit dates (actual or scheduled), projects expected DCMs, and identifies missing DCMs.
Oracle Clinical uses the date of the first received DCM as the actual visit date, and calculates the scheduled visit date from the following algorithm:
Oracle Clinical searches to find the earliest, non-null DCM date for scheduled DCMs received for the most recent planned visit with a visit number less than or equal to the missing DCM's expected visit number. If it finds such a non-null date, Oracle Clinical uses that date and visit number with the schedule of events to project the missing DCM's expected visit date.
If the first search fails, Oracle Clinical performs a broader search to find the earliest planned visit for which a scheduled or termination DCM with a non-null DCM date has been received. The date and visit number are used with the schedule of events to project back to the missing DCM's expected visit date.
If the first two searches fail, Oracle Clinical bases the schedule of events on the patient enrollment date, and projects forward the expected visit dates for missing DCMs.
Making a visit optional, as in the case of the baseline 2 and early termination visits in Table 3-1, tells the system to not report a problem if no DCMs are entered for the optional visit. However, if one or more DCMs is entered for an optional visit and other expected DCMs are not, the other DCMs become relevant and Oracle Clinical reports them as Missing.
Early termination visits are considered optional by default; normal termination visits are not optional and are handled as routine.
Table 3-1 is an example of a typical clinical study schedule that shows the planned receipt of expected (E) and optional (O) DCMs over eight visits.
Table 3-1 Clinical Study Schedule (Example)
Interval1----------------- | Interval 2-------------------------------------------------------------------------------- | |||||||
---|---|---|---|---|---|---|---|---|
Visit Numbers | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
Visit Names | Baseline 1 | Baseline 2 (opt) | Visit 1 | Visit 2 | Visit 3 | Normal Term | Early Term (opt) | Follow-up |
DCM1 |
E(mpty) |
E |
E |
O |
E |
E |
E |
E |
DCM2 |
O(ptional) |
E |
E |
E |
E |
E |
E |
E |
TDCM |
~ |
~ |
~ |
~ |
~ |
E |
E |
~ |
Table 3-1 shows that the projected visit schedule includes:
Two baseline visits, one of which is optional
Three routine visits (Visits 1, 2, and 3)
A normal termination visit
An early termination visit, which is optional
A follow-up visit
Also in Table 3-1, three DCMs are in the study schedule:
DCM1
DCM2
TDCM (Termination DCM)
If a patient withdraws from a study earlier than expected, visits scheduled after the date of early termination—that is, where dates and visit numbers are greater than the early termination visit's—are no longer expected. You can indicate that early termination has occurred in two ways:
Create an early termination visit. Any DCM logged in at that visit signals that early termination has occurred.
Create a DCM of type termination. When this DCM is logged in at any visit, that visit is considered to be the early termination visit.
Table 3-2 explains how early and normal termination visits affect DCM tracking.
Table 3-2 Termination and DCM Tracking
Termination Type | Description | Effect on DCM Tracking |
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A patient leaves the study earlier than expected; an Early Termination DCM, or Early Term type of visit, is entered. |
A visit—including a normal termination—is no longer expected if its projected date comes after the DCM Date of the Early Termination form. However, any other forms scheduled for an early termination visit are expected by the system. |
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Normal Termination |
A patient completes the study, including the normal termination visit; a Normal Termination DCM, or Normal Term type of visit, is entered. |
You can schedule some visits after the normal termination visit; scheduled visits after normal termination are projected in the same way as any other scheduled visit if an early termination has not occurred. A normal termination visit indicates that an early termination can no longer occur. |
This section contains the following topics:
Oracle Clinical provides reports and forms that interact dynamically with the schedule established during study design. This study schedule creates the framework within which visits and their associated DCMs are expected; when DCMs are missing or overdue or have discrepancies associated with them, they are reported in various levels of detail by the tools listed in Table 3-3.
Table 3-3 Tools for Tracking Missing Data
Use this window to query for missing DCMs and to mark them as Not Expected if appropriate.
Some DCMs marked as Missing may actually not be expected for that particular patient or visit. To prevent Oracle Clinical's giving a DCM a Missing status when it was not expected, mark it Not Expected in the Maintain Missing DCMs window, and add a comment about why you made the change.
You reach this window by selecting Missing DCMs from the Data Entry menu. Follow these steps:
Query for missing DCMs.
Oracle Clinical displays missing DCMs by patient number and then visit number. Scroll to the missing DCM subset you want.
Scroll to the right.
Uncheck the Expected? box if the DCM is not expected, and add optional comment text.
See information on other DCM Tracking Tools.
The DCM Detail Tracking Matrix report shows a detailed summary of DCM activities for one or more patients. See Example 3-1, "DCM Detail Tracking Matrix Report" for a sample copy of the report, followed by an explanation of the information contained in the report.
To print this report, from the Data Entry menu, select Data Entry Reports, then select DCM Detail Tracking Matrix. See "Report Parameters".
Note:
In the DCM Detail Tracking Matrix report, DCMs are displayed in ascending order by their DCM ID, not according to the sequence number in the DCM scheduling window.You can use this report in a number of ways:
Set it up to run on a regular basis so that you can dynamically monitor DCM receipt and associated validation status.
Run the Missing and Overdue DCMs report first to see where problems exist, then run the DCM Detail Tracking Matrix for a more complete diagnosis of the DCM activity for a particular patient.
Specify that the report start at the earliest visit for which a DCM was missing, especially in a long-term study, with many months of DCM activity.
Specify that the report start at the present date and project into the future. This enables a Monitor who is planning visits to an Investigator to see what CRFs need to be collected.
Run the report to identify open problems when you are closing out a study.
When you run the report you can submit the following parameters:
Investigator. Choose one from the List of Values or leave the wildcard (%) default to see results for all Investigators in this study.
Site. Choose one from the List of Values or leave the wildcard (%) default to see results for all sites in this study.
Patient. Choose one from the lists of values or leave the wildcard (%) default to see results for all patients in this study. Oracle Clinical will divide the report into sections by patient.
DCM Short Name. Choose one from the list of values or leave the wildcard (%) default to see results for all DCMs in this study.
DCM Subset Name. Choose one from the list of values or leave the wildcard (%) default to see results for all DCM Subsets in this study.
Target Receipt Day Off Schedule. Optional; 29 if null.
Start Date. The first date for which you want to see response data.
End Date. The last date for which you want to see response data. If blank, the system uses the current date.
Only from Earliest Visit Having a Missing DCM?. Enter Y or N for Yes or No.
Discrepancy Query Status 1-3. You can query for up to three discrepancy review statuses. Optional; list of values available.
Example 3-1 illustrates a page from a typical DCM Detail Tracking Matrix report that documents two events. Visit 1 represents a Received DCM. Visit 2 represents a Missing DCM. For a key to the contents of the Visit column table cells, see Table 3-4, "Detail Tracking Matrix Table Cell Key: Received DCMs" and Table 3-5, "Detail Tracking Matrix Table Cell Key: DCMs Not Received". For a key to the status code abbreviations in those cells, see Table 3-6, "Data Entry Statuses for Received DCMs (Optional or Expected)", Table 3-7, "RDCM Validation Statuses", and Table 3-8, "Statuses for DCMs Not Received".
Example 3-1 DCM Detail Tracking Matrix Report
08-JUL-2000 13:22 | Page: 5 of 14 | |||
DCM Detail Tracking Matrix for Study BLANKET | ||||
Investigator: | 01239 | Site: | 500171 | Patient: 1 |
Short Name |
Subset Name |
Qualifying Value |
VISIT 1 | VISIT 2 |
DEMG |
DEMOG |
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LOCK S23481 01-JAN-2000p. 10 |
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PG |
PG |
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LOCK A567 31-MAR-96 p. 13 |
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VTLS |
VITALS |
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LOCK DIS A345 01-JAN-2000p. 10 |
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DAL |
DCDAL |
ALLERGY |
LOCK DIS 123496 10-APR-96 P. 20 |
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S025 |
SPR17025 |
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LOCK DIS SPR17025 01-JAN-96 p. 75 |
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TEST |
CHAR |
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LOCK S34511 06-JUL-96 |
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DeviationFoot 1 (Days) |
189 |
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0 |
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DurationFoot 2 (Days) |
-- |
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-99 |
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Interval (Days): |
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SchdFoot 3 (Min/Max) |
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5/5 |
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CalculatedFoot 4 |
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-99 |
Footnote 1 Total number of days between the earliest and latest date recorded in a DCM at that visit.
Footnote 2 Total number of days since the first event (beginning of a study).
Footnote 3 Minimum and maximum number of days between this visit and the previous scheduled visit.
Footnote 4 Actual number of days between the current visit and the previous, planned visit. Value is calculated from the maximum date recorded at each visit.
Oracle Clinical gives all received DCMs (RDCMs) a Data Entry status such as Received, Pass 1 Started, and so forth (see Chapter 1, "Entering Data"). Table 3-6, "Data Entry Statuses for Received DCMs (Optional or Expected)" contains a complete list of these statuses with their meanings. This status appears in the DCM Detail Matrix report in the first line under each visit.
Table 3-6 Data Entry Statuses for Received DCMs (Optional or Expected)
Status | CodeFoot 1 | Description |
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Received |
RCVD |
The DCM was logged in. |
Blank |
BLNK |
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P1-S |
Data Entry Pass 1 was started. |
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P1-C |
Data Entry Pass 1 was completed. |
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P2-S |
Data Entry Pass 2 was started. |
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P2-C |
Data Entry Pass 2 was completed. |
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Locked |
LOCK |
The received DCM has been locked. You cannot modify the DCM except under Privileged Data Entry Update. |
Footnote 1 Displayed only in the "How to Use This Report"
Oracle Clinical assigns a validation status for Received, or entered, DCMs (RDCMs) that indicates whether the RDCM is associated with one or more open univariate or multivariate discrepancies. If there is a discrepancy associated with the RDCM, the code appears in the DCM Detail Matrix Report to the right of the Data Entry status code in the first line under each visit. If there are no discrepancies associated with the RDCM, no validation status code is displayed. Table 3-7, "RDCM Validation Statuses" contains the RDCM status code information.
Table 3-7 RDCM Validation Statuses
Status | Code | Meaning |
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Not discrepant |
(Blank; no code.) No open discrepancies associated with the RDCM. |
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Discrepant |
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One or more open univariate discrepancies are associated with the RDCM. |
Query |
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One or more open multivariate discrepancies are associated with the RDCM; you can define up to three review statuses and apply them to the RDCM. |
A discrepancy is considered "open" if its status is current and it has not been resolved.
During study definition, when you associate DCMs and DCM subsets with the DCM schedule, you mark them as either E (Expected) or O (Optional). DCMs that are not received and are marked as O in the DCM schedule simply get a status of Optional.
For a DCM marked E and Not Received on the expected visit date, the status indicates its degree of lateness, such as Missing, Off-targ, or Overdue (see Table 3-8, "Statuses for DCMs Not Received").
Table 3-8 Statuses for DCMs Not Received
Status | CodeFoot 1 | Description |
---|---|---|
Optional |
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The DCM is not expected because it was defined as Optional during study definition. |
Not Expected |
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The DCM is not expected because a user gave it this status in the Maintain Missing DCMs window (see "Maintain Missing DCMs Window"). |
Missing |
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The DCM was not received at the expected visit, but other DCMs were received during that visit or subsequent visits. |
Overdue |
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The DCM was not received at the expected visit and 30 or more days have passed since the expected date for that visit; also, no other DCMs have been received for that visit or later visits. |
Missing and |
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The DCM is missing and 30 or more days have passed since the expected date for that visit. |
OffTarget |
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The DCM has not been received within the user-specified target days since the expected date for that visit. A user can specify a target date of 0-29 days from the expected visit. |
Missing and Off-Target |
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The DCM is missing and the user-specified number of target days have passed since the expected date for that visit. |
Footnote 1 Displayed only in the "How to Use This Report"
To submit this report, from the Data Entry menu, select Data Entry Reports, then select Missing and Overdue DCMs.
This report provides the following information about missing and overdue DCMs for the parameters you select, organized by patient:
visit at which the DCM was expected to be collected
whether the DCM is missing or overdue
date of the visit, and whether the visit occurred (Actual; other DCMs were collected) or was only Scheduled (no other DCMs have been entered for the visit)
the number of days overdue
short name of the DCM and subset
missing DCM page(s)
To run this report, enter the following parameters:
Investigator. Choose one from the list of values or leave the wildcard (%) default to see results for all Investigators in this study.
Site. Choose one from the list of values or leave the wildcard (%) default to see results for all sites in this study.
Patient. Choose one from the list of values or leave the wildcard (%) default to see results for all patients in this study.
DCM Name. Choose one from the list of values or leave the wildcard (%) default to see results for all DCMs in this study.
Missing DCM Status. Choose one from the list of values or leave the wildcard (%) default to see results for all missing DCM statuses in this study. The abbreviations used for the list of values here are: M for Missing, O for Overdue, MO for Missing and Overdue, OT for Off Target, and MT for Missing and Off Target. See Table 3-8, "Statuses for DCMs Not Received" for further information on the meaning of these statuses.
Start Date. The first date for which you want to see response data.
End Date. The last date for which you want to see response data. If blank, the system uses the current date.
Target Receipt Days Off Schedule. The number of days that the DCM is overdue. You can use this parameter to report DCMs that are exactly a certain number of days overdue.
To submit this report, from the Conduct menu, select Conduct Reports, then select Data Validation, and then Investigator Corrections and Missing Pages.
This report provides the following information about missing pages for the parameters you select, organized by patient:
First a summary, giving, for each patient:
first visit number and date of first visit
latest visit number and date of latest visit
next planned visit number and date
status
Second, a detailed section organized by patient and visit, with information for each RDCM with a problem:
number and date of visit when problem occurred
whether the visit was Actual (other DCMs were collected) or Scheduled (other DCMs were not collected)
the nature of the problem (for example, missing pages)
To run this report, enter the following parameters:
Investigator. Choose an Investigator from the list of values.
Patient. Choose one from the list of values or leave the wildcard (%) default to see results for all patients in this study.
DCM Name. Choose one from the list of values or leave the wildcard (%) default to see results for all DCMs in this study.
Modified Since.
Modified Until.
Summary Reporting Inclusion Flag.
Discrepancy Reporting Inclusion Flag.
Missing Pages Reporting Inclusion Flag.
Company Name.