HOW TO MAKE WISE

POST-PRODUCTION CHANGES TO

ORACLE CLINICAL/RDC STUDIES

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ABOUT PERFICIENT

Perficient is a leading information

technology and management

consulting firm serving clients

throughout North America.

We help clients implement digital experience, business

optimization, and industry solutions that cultivate and captivate

customers, drive efficiency and productivity, integrate business

processes, improve productivity, reduce costs, and create a

more agile enterprise.

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Founded in 1997

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California, Oxford (UK), Southern California,

St. Louis, Toronto

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PERFICIENT PROFILE

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OUR SOLUTIONS PORTFOLIO

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ION

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+ P

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WELCOME / INTRODUCTION

Tammy Dutkin

Director of Clinical Data Management & EDC, Perficient

• 20+ years of clinical research and data management experience

• Previously SVP at DSP Clinical Research and VP at Advanced

Clinical

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AGENDA

• Intro to post-production changes

• Warnings

• Process

• Things to consider/impact analysis

• DCM changes

• Migrating form versions

• DCI form local study settings

• Visit changes

• DCI book changes

• Summary

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INTRO TO POST-PRODUCTION CHANGES

Post-Production Changes NOT uncommon

– CRFs are final

– Patients have been enrolled / data collected

– Data entered into OC

– Etc.

Reasons for changes:

– Protocol amendment

– CRF modifications

– Changes to working processes or requirements

– Etc.

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WARNINGS

• Document what you intend to do and the impact of those changes

• Get approval BEFORE you do anything. Any error here can have

HUGE impacts

• Create things provisionally and TEST, TEST, TEST before you activate.

If you can’t test (e.g. new form version) then have someone else

double check your work

– A good way to test is to clone your production data into a test database. Many of the

changes you may need to make, you will not be able to test in your production study

• Activate and confirm the changes rolled out as expected (check old

data, new data, procedures, extracts, discrepancies)

• Document and close any loops

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PROCESS

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THINGS TO CONSIDER / IMPACT ANALYSIS

Before making any changes:

1. Assess the impact the change is going to make on:

– Your overall study objectives

– Your study timelines

– Patient data already entered in the study (including how much data)

– How many discrepancies might fire due to this change and how will those

discrepancies be handled?

– Current study set up (e.g. procedures that may be impacted, extract views that may

need to be updated)

– Verification and Approval statuses (retained or revoked)

– Documentation that may need to be updated (e.g. annotations, change

documentation)

2. Assess the options available for changing the database

– Can the issue be handled with a convention or note to file other than a database

change?

– Does the change need to be applied to only new data or to both new and old data?

– Is the database change even possible?

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THINGS TO CONSIDER / IMPACT ANALYSIS

3. Evaluate the risk associated with the change

– Will it require system downtime?

– How will the change be communicated to affected parties?

– Is there a risk of losing or corrupting data?

4. What is the cost of the change?

– How much resource time will be spent on the change?

5. Is the benefit worth the impact/risk/costs?

WARNING: Changes that appear (and are) simple to make in OC may have

far-reaching impacts

– Think about & ask the right questions to ascertain all the potential impacts

– All the potential impacts and subsequent tasks/changes should be included

on the Impact Analysis BEFORE any changes are made

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DCM CHANGES

• Updating a DVG

• Adding a DCM question

• Removing a DCM question

• Minor updates to labels, question order, header

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DCM CHANGES – DVG UPDATES

• Things to consider if adding a DVG choice:

– Is there data already entered for that question?

• What do you want to happen with that data?

• Do you want the sites to re-evaluate their selection for the

question or do you want those forms to stay on the old version?

(If so, you may need to add a validation to prompt the sites to

do this.)

• How many discrepancies (univariate, multivariate, etc.) are

going to fire due to the change? How will these be handled?

– How many characters long is the new choice? Do you need to

increase the question length? If so, don’t forget to update the views.

– How is the data displayed on the form? LOV? Checkboxes? LOV

DVG changes do not require a Form Layout change.

– Does this impact default repeat values or default responses?

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DCM CHANGES – DVG UPDATES

• Things to consider if removing a DVG choice…

– Is there data already entered for that question for the DVG choice

being removed?

• What do you want to happen with that data?

• Keep in mind that removing a selection that was chosen

previously may result in discrepancies firing.

– How is the data displayed on the form? LOV? Checkboxes? LOV

DVG changes do not require a Form Layout change.

– Does this impact any default repeat values or default responses?

– Does it impact any procedures?

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DCM CHANGES – DVG UPDATES

Steps to updating a DVG (assuming all patients will be using the new DVG):

1. Create new version of the DVG

2. Update the DVG version in the DCM

3. Uncheck the Available checkmark for Graphic Layout, if needed

4. Select SpecialGraphic LayoutUpdate DVG from DVG Definition, Edit

layout if needed

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DCM CHANGES – DVG UPDATES

Steps to updating a DVG:

5. Recheck Available (note: if this is a LOV DVG, nothing further is needed)

6. Go to DCIGenerate Provisional Layout, Edit Layout

7. Generate Provisional DCI Form

8. Activate (note if there is no data entered in the current active layout, can just

delete or edit the original layout without creating a new version). All new

patients will have the new version of the layout, unless something other than

“Current” is selected in the DCI book constraints.

9. Migrate Form Version by Book, using the original book, all patients with data

will move to the new form – check the test box and confirm and then run

again with test box unchecked Note: Can schedule this off hours – will skip

records if they are open by a user. See log.

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DCM CHANGES – DVG UPDATES - EXAMPLE

Example: An additional Race code of “AMERICAN INDIAN” is needed for

DEMOGRAPHICS

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DCM CHANGES – DVG UPDATES - EXAMPLE

1. Create new version of the DVG

a. First add the new choices to the base DVG

b. Next create new subset,

renumber as needed

and activate

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DCM CHANGES – DVG UPDATES - EXAMPLE

2. Update DCM with the new DVG

3. Uncheck Available for

DCM Graphic Layout.

4. Update DVG definition and

Edit layout as needed

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DCM CHANGES – DVG UPDATES - EXAMPLE

5. Recheck that layout is Available

6. Go to DCIGenerate Provisional Layout, Edit Layout

7. Generate Provisional DCI Form

8. Activate (this will retire the old Form Version)

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DCM CHANGES – DVG UPDATES - EXAMPLE

Now for all new data entered, the new form version will appear…

Previously entered data will appear as the old form version until you migrate

the data…

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DCM CHANGES – ADDING A QUESTION

• Things to consider if adding a question:

– Is there data already entered for that DCM?

• What do you want to happen with those eCRFs?

• Do you want the new question to appear on previously entered

eCRFs?

• Do you want the sites to have to go back and enter that

question?

• Keep in mind that if you decide to create a new DCM subset,

the old data will not “migrate” to that new DCM. It will have to

stay in the old form.

– Update all documentation (e.g. annotations)

– Check for new validations or derivations that may be needed

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DCM CHANGES – ADDING A QUESTION

Adding DCM questions (assuming you are not creating a new DCM or a new DCM subset)

1. Add new question to DCM

2. Graphic Layout will automatically change to Not Available

3. Select SpecialGraphic LayoutEdit and edit as needed

4. Mark Graphic Layout as Available

5. Go to DCIGenerate Provisional Layout, Edit Layout (if no data entered, edit the current layout)

6. Generate Provisional DCI Form

7. Activate layout

8. Migrate Form Version by Book

(If you want some patients to stay on the old version of the form, you can do so by changing the constraints in the assigned DCI book.)

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DCM CHANGES – REMOVING A QUESTION

• Things to consider if removing a question:

– Is there data already entered for that question?

• What do you want to happen with that data?

• Do you want the data available for the sites to view/modify?

– You cannot mark the question as not collected in study, only as not

collected in subset

– Did you want the previously entered data present in the extract views?

– Update all documentation (e.g. annotations)

– Is that question used as a trigger question?

– Is that question used in any derivations/validations that may need to be

reprogrammed?

– Note: If you mark a question as Not collected in Subset, until you

migrate the form, it will appear on the form in RDC but will be non-

enterable.

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DCM CHANGES – REMOVING A QUESTION

Removing DCM questions (assuming you are not creating a new

DCM or a new DCM subset)

1. Mark the question as Not Collected in Subset

2. Graphic Layout will automatically change to Not Available

3. Select SpecialGraphic LayoutEdit and edit as needed

4. Mark Graphic Layout as Available

5. Go to DCIGenerate Provisional Layout, Edit Layout (if no data

entered, edit the current layout)

6. Generate Provisional DCI Form

7. Activate layout

8. Migrate Form Version by Book

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MIGRATING VERSION FORMS

• You can only have one active DCI Form Version

• When a new Form Version is activated, all new eCRFs will use that new Form Version

• If no data has been entered for an active form, the active form should be made Provisional, Edited, and Re-Activated

• Previously entered eCRFs will use the old form until data is migrated from the old form to the new form (unless you have assigned a preferred version of that DCI as a constraint in the assigned DCI book)

• Depending on your FLT, the eCRF form version being used may not be readily transparent. So be careful in not migrating your old data to the new form! It is possible to add the Form Version to a FLT.

• If you don’t want to migrate your old data to the new form, you can create a new DCM or DCM subset and a new DCI or you can add a constraint to the assigned DCI book to point to a specific form version

• Migration is done using Definition DCIs Migrate Form Version by Book

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MIGRATING VERSION FORMS

The option to retain/reverse can be set in the DCI Form Local Study Settings

(Note: The choices for Reason are found in a Installation Reference Codelist)

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DCI FORM LOCAL STUDY SETTINGS

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USING A RETIRED FORM VERSION

DCIs Enhanced DCI Book Constraints

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VISIT CHANGES

• Updating a CPE Name

– Can update name of CPE and it applies it across all subjects no matter if

data is entered or not (automatically updates all records and DCI Book)

– Even if someone is logged in while the change is happening, it updates

everything with no errors

• Adding additional CPEs

– May have issues if study is a flex study with interval rules

– If you aren’t going to include some visits, you can mark them as optional

• Removing a CPE

– Can’t delete visits from the Enhanced DCI books. Visits without any DCIs

will not appear (unless data was previously entered). If data was entered,

that visit will always appear for those subjects even if you change their

assigned DCI Book or delete that data

– Can’t delete Events from a study that has data

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VISIT CHANGES - EXAMPLE

• Updating a CPE Name - Visit of FOLLOWUP needs to be changed to

FOLLOWUP 1 and the Visit No. updated to 100.

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VISIT CHANGES - EXAMPLE

When the CPE is updated, the Navigator then looks like this

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DCI BOOK CHANGES

• Updating a DCI Book

– Can’t delete visits from the Enhanced DCI books. Visits without any DCIs will not appear (unless data was previously entered).

– Adding a New Form or Removing a Form

• This can be done within the current DCI book, but you may run into issues with renumbering the book pages or with DCI/Interval Rules and then the action cannot be easily undone

• Better to create a new DCI book when adding or removing forms.

• Make sure to take into account new or affected procedures with the change

– Create new DCI book, make updates, renumber Book pages(if needed), Validate DCI book, resolve any errors, make active. Assign the new DCI book as needed. Recalculate expectedness as needed.

• Creating a new DCI Book

– The process to assign a new DCI book to individual patients is time consuming. Plan accordingly!

– A batch session must be run after DCI book re-assignments in order to recalculate expectedness.

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DCI BOOK CHANGES - EXAMPLE

Adding a New Form to a New Visit in the existing DCI Book –

Change needed to collect Lab results at a new Visit (Visit 2)

1. Add the new Visit to the Event Schedule

2. Made the DCI book provisional

3. For VISIT 2, added the new DCI book page of LABORATORY

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DCI BOOK CHANGES - EXAMPLE

4. Renumber book pages

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DCI BOOK CHANGES - EXAMPLE

5. Validate DCI Book and View Validation Results to confirm there are no

errors. Re-Activate your DCI book.

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DCI BOOK CHANGES - EXAMPLE

Migration is not needed as no form-level changes were made. The new

visit and new form will be available to all subjects assigned to that DCI

book immediately. (Note: Users who are already logged into the system

while the change is being made, may need to logout and log back in to

see the change.)

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SUMMARY

Changes that appear (& are) simple to make in OC, may have far-

reaching impacts

– Think about/ask the right questions to ascertain all the potential

impacts

– All the potential impacts and subsequent tasks / changes should be

included on the Impact Analysis BEFORE any changes are made

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QUESTIONS?

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CONNECT WITH US

• Tammy.Dutkin@perficient.com

• LifeSciencesInfo@perficient.com

• +1 919 462 6395 (U.S. Sales)

• +44 (0) 1865 910200 (U.K. Sales)

• Blogs.perficient.com/lifesciences

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• Twitter.com/Perficient_LS

• Facebook.com/Perficient

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THANK YOU