Slide 1: CDMS User Community Meeting
CDMS User Community Meeting Item to Form Linking - 22R1 Feature Highlight May 2022
Slide 2: Customer Success Managers (CSM), CDMS Customer Success
Customer Success Managers (CSM), CDMS Customer Success Pratik Patel Bill Nazzaro CSM, Presenter CSM, Presenter Megan Ferris Melanie Migliore CSM, Presenter CSM, Presenter
Slide 3: Interact With Us!
Interact With Us! Questions? cdmscustomersuccess@veeva.com Copyright © Veeva Systems 3 2021
Slide 4: Agenda
Agenda •Feature Review •Role specific perspectives − CRC − Data Reviews − Extracts and Listings − Studio Design • Safety Updates •References & Upcoming Dates Copyright © Veeva Systems 4 2021
Slide 5: Item to Form Linking
Item to Form Linking • Why this feature was added? − More specificity and seeing the specific items directly on the form − Reduce toggling from form to linked form − People forgetting to link forms − Refined per needed query rules, so sites don’t miss linking the related data - progressive display &
Slide 6: CRC
V CRC
Slide 7: Item to Form Linking
Item to Form Linking Copyright © Veeva Systems 7 2021
Slide 8: Item to Form Linking
Item to Form Linking Copyright © Veeva Systems 8 2021
Slide 9: Item to Form Linking
Item to Form Linking Copyright © Veeva Systems 9 2021
Slide 10: DEMO
DEMO Copyright © Veeva Systems 10 2019
Slide 11: Data Review
V Data Review
Slide 12: Overall Benefits for Data Review
Overall Benefits for Data Review • Facilitate and speed for SDV and DMR − On screen, no need to jump from one screen to another − On extract, linkage information available in datasets/listings • Increased data quality − Item can be required, allowing for a query to be raised if the item link is blan
Slide 13: Review UI View
Review UI View • As with any other item, a reviewer with permission can: − Query − Mark as Reviewed − Freeze − Lock − Create a Protocol Deviation − View the Audit Trail Copyright © Veeva Systems 13 2021
Slide 14: DEMO
DEMO Copyright © Veeva Systems 14 2019
Slide 15: Data Extracts
V Data Extracts
Slide 16: Extraction of item to form linking data
Extraction of item to form linking data • Data regarding item to form linking information can be found in different extracts − Study Data Extracts System Datasets • SYS_LINKS: no changes. Show the link between forms using the sequence number − Study Data Extracts Clinical Datasets / Core Listings Ne
Slide 17: Generating the SDE
Generating the SDE • EDC Tools > Select Study > Jobs > New Job > Study Data Extract • Complete Job Options Copyright © Veeva Systems 17 2021
Slide 18: Generating the SDE
Generating the SDE • Complete Data Export Copyright © Veeva Systems 18 2021
Slide 19: Core Listings
Core Listings • EDC Tools > Select Study > Jobs > New Job > Core Listings • Review > Select Study > Listings & Exports > New > Core Listings Copyright © Veeva Systems 19 2021
Slide 20: Clinical datasets variables
Clinical datasets variables Variable Name Description Variable Example (Form Link ItemDef Name)_DEF External ID of the item used to create the form linking Ex: AE_CM_DEF variable or AE_PR_DEF variable If multiple items to form linking in the CRF page, multiple variables will be shown in extract (1 p
Slide 21: Clinical datasets variables
Clinical datasets variables AE “Headache” is linked to Concomitant Medication Form record #1 (which has a FormOID) . The AE form is linked to 2 forms (Procedure and Concomitant therapy) . Following items were used to make the link. Delimiter if multiple links is the “pipe” char. Not shown due to spa
Slide 22: Output when ILB
Output when ILB If a record previously linked to another record is Set Intentionally Left Blank - The link is kept and visible in the output - Linked items are showing as “null” Copyright © Veeva Systems 22 2021
Slide 23: Output when Reset Form
Output when Reset Form When resetting a form: 1. Remove the link first choosing the “Clear” option 2. Reset the form Output will not show the link as it has been cleared Copyright © Veeva Systems 23 2021
Slide 24: Coder
V Coder
Slide 25: Seeing Item to Form Linking in Coder (1)
Seeing Item to Form Linking in Coder (1) Copyright © Veeva Systems 25 2021
Slide 26: Studio Designers
V Studio Designers
Slide 27: Considerations During Study Build
Considerations During Study Build • Which form(s) will I use item link(s)? • What wording will I use for the item link? − The reason for relating the form(s) to the item • Other medication given? [for the AE] vs. Did this Medication cause an AE? • What questions from the linked form should be includ
Slide 28: Considerations During Study Build
Considerations During Study Build • Library Collection revisions Copyright © Veeva Systems 28 2021
Slide 29: DEMO
DEMO Copyright © Veeva Systems 29 2019
Slide 30: Item Links - Single
Item Links - Single AE - related Procedure EOT/EOS - Discontinued due to AE Copyright © Veeva Systems 30 2021
Slide 31: Item Links - Multiple
Item Links - Multiple Repeating item group with the Form Link Copyright © Veeva Systems 31 2021
Slide 32: Rule Expression Examples - Repeat IG
Rule Expression Examples - Repeat IG The same link is selected more than once Copyright © Veeva Systems 32 2021
Slide 33: Rule Expression Examples - Repeat IG
Rule Expression Examples - Repeat IG No Link has been added to the repeating IG. Copyright © Veeva Systems 33 2021
Slide 34: Rule Expression Examples - Checking Values
Rule Expression Examples - Checking Values AE Stop Date is > Date of Discontinuation: Did the AE cause the Subject to Be Discontinued From the Study? Is not Yes for the linked AE Copyright © Veeva Systems 34 2021
Slide 35: Rule and Validation Best Practices
Rule and Validation Best Practices • Use validated features to reduce Rule programming and UAT efforts − Use Progressive Display − Use Required Checks • Review and remove any previous User Defined Rules • Create User Defined Rules to evaluate data values in linked forms − Confirm start/end dates for
Slide 36: Safety Link Configuration
V Safety Link Configuration
Slide 37: Safety Link
Safety Link • Using Item to Form linking, customers using our Safety Link integration can include ‘Characterization of Drug Role’ in a case − Requires a code list item included within the link item Item Group − Configuration is done on the CM section of the E2B Copyright © Veeva Systems 37 2021
Slide 38: Closing
V Closing
Slide 39: Item to Form Linking
Item to Form Linking • Why this feature was added? − More specificity and seeing the specific items directly on the form − Reduce toggling from form to linked form − Users forgetting to link forms − Refined per needed query rules, so sites don’t miss linking the related data - progressive display &
Slide 40: References
References • About the 22R1 Release • What’s New in 22R1 • Release Impact Assessment (xls) • Compliance Docs Registration • Community Copyright © Veeva Systems 40 2021
Slide 41: Upcoming Webinars & Releases
Upcoming Webinars & Releases Important Dates ➢ Look for upcoming Webinars this summer ➢ Next Release • 22R2 - Aug 5th Veeva Trust Site https://trust.veeva.com/ Email for feedback and Suggestions for upcoming Webinar topics cdmscustomersuccess@veeva.com Copyright © Veeva Systems 41 2021
Slide 42: Questions?
Questions? cdmscustomersuccess@veeva.com
Slide 43: Thank you
V Thank you