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Medidata Rave® Custom Functions Webinar

Medidata Rave® Custom Functions Webinar. Implementing the Rave Custom Functions Best Suited to your Clinical Study Requirements. Today’s Speakers. Venkat Sungishala - Sr. Manager of EDC at Clinovo Experience : 5+ years experience of extensive clinical programming & study build

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Medidata Rave® Custom Functions Webinar

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  1. Medidata Rave® Custom Functions Webinar Implementing the Rave Custom Functions Best Suited to your Clinical Study Requirements

  2. Today’s Speakers Venkat Sungishala - Sr. Manager of EDC at Clinovo Experience: 5+ years experience of extensive clinical programming & study build using Medidata Rave® Specialties: Medidata certified “Rave 5.6.3/5.6.4 Study Builder” Marc Desgrousilliers – Vice President of Operations at Clinovo Experience: 20 years experience in software and engineering

  3. Today’s Agenda • Study Build in Rave® • Edit Checks and Derivations • Benefits of Custom Functions • Best Practices around the use of Custom Functions • Q & A

  4. Study Build in Rave® - Streamlining your Clinical Trial Process -

  5. Study Configuration in Rave® Study in Rave® is a collection of eCRFs, folders/visits, matrices and approved user role permissions which satisfies the study protocol Configuration is simple and can be done with good training As you configure the study, you are building standard based global libraries. These will enable you to reduce the overall development time and validation cost Carry out the clinical trial in a structured and timely manner

  6. What is configurable in Rave®? UI and solid workflow configuration eCRF/folder/matrix design Controlled access to eCRFs/data entry Edit checks to run the business logic Derivations to calculate values Custom functions to handle dynamic requirements Global library set-up to reuse standard architect elements Example: eCRFs, fields, variables or matrices… Reports configuration adapted to your needs Example : audit trial report, query detail report and monitor visit report…

  7. Edit Checks and Derivations - Improved Data Cleaning, Faster Clinical Trial -

  8. Edit Checks and Derivations What are Edit checks? Rule/logic applied on a field in a CRF Catching errors earlier in the clinical trial process & improve your data accuracy Example : If the VISITDT is empty then fire a Query with message: The visit date should not be blank What are Derivations? Calculation that derives a value based on the business logic Less data entry & automatic calculation Example : If BIRTHDT and SCRNDT are NotEmpty then Derive AGE field

  9. Limitations of Edit Checks and Derivations Do not support: • Dynamic folders • Form inactivation • Dynamic subject calendar • Email with specific fields data • Dynamic queries • Auto number generation • Chronological order of dates edit checks • Dynamic search list • … Edit Checks Derivations Do not support: • Complex mathematical algorithms • Data in different forms/folders • Specific derivations on variables shared across multiple forms • …

  10. Limitations of Editchecks and Derivations Example: Derive ‘DaysDiff’ field in derivation form with difference between SCRNDT in screening form and VISITDT in corresponding Day 1, Day 8 and Day 15 folders Requirement: Cycle is repeated in folder: Cycle 1, Cycle 2, …, Cycle n Day 1, Day 8 and Day 15 are the folders & exist in all cycles Derivation is a form & exists in Day 1, Day 8 and Day 15 folders Given: SCRNDT = 01 JAN 2011 Cycle 1>Day 1>VISITDT = 05 JAN 2011 then DaysDiff is derived with 4 Cycle 2>Day 1>VISITDT = 21 JAN 2011 then DaysDiff will be derived with 20 in Cycle 2>Day 1 and also affect the value in Cycle 1>Day 1 folders Enter:

  11. Custom Functions - Solutions adapted to your Complex Study Protocol Requirements -

  12. Basic Concepts of Custom Functions • What is a custom function in Rave®? • Custom Function defines the business logic implemented on an eCRF • It can be a C#, Visual Basic or SQL piece of code developed outside of Rave® and injected into the system to perform an intended action • What experience is needed to develop custom functions? • Study build experience with Rave® • Good knowledge in object oriented programming concepts • Good knowledge of C# and SQL programming

  13. Benefits of Custom Functions • Dynamic query messages and search lists • Configurable AE/SAE emails • Role/user based emails • Adding/inactivating of forms/folders/matrices • Copying data • Configuration of dynamic protocol requirements: • Adding required number of records • Visible/invisible fields • Data comparisons/validations • Standard CFs can be reused for future study builds • … Faster Study Build Improved Data Accuracy Flexibility allowing more Customization

  14. Categories of Custom Functions Custom Functions (CFs)can be categorized into: • Simple CFs • Moderate CFs • Complex CFs

  15. Categories of Custom Functions • Simple custom functions • Very simple business logic • Applied on a single form Example: Add a form in the same folder A few more examples: • Populate or derive data into a field in the same form • Verify the fields data is in a pre-defined format • Display query message or place a sticky within a single form • Visible/invisible fields in the same form • Adding log records into a form • …

  16. Categories of Custom Functions • Moderate Custom Functions • Comparison of multiple forms Example: Display query message or place a sticky based on data from multiple forms • A few more examples: • Adding log records and populating data into a form • Adding a form in the different folder • Adding folder and adding matrices dynamically • Populate or derive data based on the data in multiple forms • Data comparisons and checking for the chronological order • …

  17. Categories of Custom Functions • Complex Custom Functions • Comparison of multiple forms • Requires SQL script Example: Generating sequential patient or randomization numbers • A few more examples: • Subject calendar for the visits • SAE emails based on roles • Checking for uniqueness of the entered data • Dynamic search list • Multiple matrices • Nested folders • …

  18. Best Practices - Around the use of Custom Functions -

  19. Best Practices • Use header below to identify and trouble shoot a CF: • Check for NULL objects • Check Active status of all objects • Avoid using try-catches because Rave does it for you

  20. Best Practices • Keep the code simple and readable… but if you want to improve system performance: • Use OIDs rather than names • Avoid using foreach • Avoid writing nested for loops • Loop handling: • Avoid sending emails in a loop • Remember to breakout the loop when search is completed • Email Handling: • Check the environments before sending an email • Avoid using same email ID for different environments • Stored Procedure Handling: • Use SQL stored procedures instead of dynamic SQL • Avoid stored procedures for updates or deletions

  21. Q & A

  22. Thank You for your Attention ! Visit our website for upcoming webinars: www.clinovo.com

  23. Contact Clinovo 1208 E Arques Ave. Suite 114 Sunnyvale, CA 94085 www.clinovo.com Marc Desgrousilliers, VP of Operations marc@clinovo.com 408 773 6253 Venkat Sungishala, Sr. Manager of EDC venkat@clinovo.com 408 845 0862

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