Medidata Rave® Custom Functions

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Configuring a clinical EDC study in Medidata Rave is simple with good training. Study builders can easily configure eCRFs and review complex edit checks and derivations. However, they often face limitations in Rave when using edit checks and derivations. As we will demonstrate in our webinar, custom functions are better adapted to address complex study protocol requirements. Our Medidata Rave experts will discuss key benefits and programming techniques to implement the custom functions best-suited to your clinical study requirements.

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<ul><li><p>Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 contact@clinovo.com +1 800 987 6007 www.clinovo.com </p><p>Tuesday, October 11th 2011 </p><p>Medidata Rave Custom Functions Webinar </p><p>Implementing the Rave Custom Functions Best Suited to your Clinical Study Requirements </p></li><li><p>Proprietary and confidential </p><p>2 Rave Custom Functions October 11h 2011 </p><p>Todays Speakers </p><p>Venkat Sungishala - Sr. Manager of EDC </p><p>Experience: 5+ years experience of extensive clinical programming &amp; study build </p><p> using Medidata Rave </p><p>Specialties: Medidata certified Rave 5.6.3/5.6.4 Study Builder </p><p>Marc Desgrousilliers Chief Technology Officer </p><p>Experience: 20+ years experience in software and engineering </p></li><li><p>Proprietary and confidential </p><p>3 Rave Custom Functions October 11h 2011 </p><p>Todays Agenda </p><p> Study Build in Rave </p><p> Edit Checks and Derivations </p><p> Benefits of Custom Functions </p><p> Best Practices around the use of Custom Functions </p><p> Q &amp; A </p></li><li><p>Proprietary and confidential </p><p>4 Rave Custom Functions October 11h 2011 </p><p>Study Build in Rave - Streamlining your Clinical Trial Process - </p></li><li><p>Proprietary and confidential </p><p>5 Rave Custom Functions October 11h 2011 </p><p>Study Configuration in Rave </p><p> Study in Rave is a collection of eCRFs, folders/visits, matrices and approved user role permissions which satisfies the study protocol </p><p> Configuration is simple and can be done with good training </p><p> 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 </p><p> Carry out the clinical trial in a structured and timely manner </p></li><li><p>Proprietary and confidential </p><p>6 Rave Custom Functions October 11h 2011 </p><p>What is configurable in Rave? </p><p> UI and solid workflow configuration </p><p> eCRF/folder/matrix design </p><p> Controlled access to eCRFs/data entry </p><p> Edit checks to run the business logic </p><p> Derivations to calculate values </p><p> Custom functions to handle dynamic requirements </p><p> Global library set-up to reuse standard architect elements </p><p> Example: eCRFs, fields, variables or matrices </p><p> Reports configuration adapted to your needs </p><p> Example : audit trial report, query detail report and monitor visit report </p></li><li><p>Proprietary and confidential </p><p>7 Rave Custom Functions October 11h 2011 </p><p>Edit Checks and Derivations - Improved Data Cleaning, Faster Clinical Trial - </p></li><li><p>Proprietary and confidential </p><p>8 Rave Custom Functions October 11h 2011 </p><p>Edit Checks and Derivations </p><p>What are Edit checks? </p><p> Logic rule applied to a field in a eCRF </p><p> Catching errors earlier in the clinical trial process &amp; improve your data accuracy </p><p> Example : If the VISITDT is empty then fire a Query with message: The visit date should not be blank </p><p>What are Derivations? </p><p> Calculation that derives a value based on the business logic </p><p> Less data entry &amp; automatic calculation </p><p> Example : If BIRTHDT and SCRNDT are NotEmpty then Derive AGE field </p></li><li><p>Proprietary and confidential </p><p>9 Rave Custom Functions October 11h 2011 </p><p>Limitations of Edit Checks and Derivations </p><p>Do not support: </p><p> Dynamic folders </p><p> Form inactivation </p><p> Dynamic subject calendar </p><p> Email with specific fields data </p><p> Dynamic queries </p><p> Auto number generation </p><p> Chronological order of dates edit checks </p><p> Dynamic search list </p><p> Etc. </p><p>Do not support: </p><p> Complex mathematical algorithms </p><p> Data in different forms/folders </p><p> Specific derivations on variables shared across multiple forms </p><p> Etc. </p><p>Edit Checks Derivations </p></li><li><p>Proprietary and confidential </p><p>10 Rave Custom Functions October 11h 2011 </p><p>Limitations of Editchecks and Derivations </p><p>Derive DaysDiff field in derivation form with difference between SCRNDT in screening form and VISITDT in corresponding Day 1, </p><p>Day 8 and Day 15 folders </p><p>SCRNDT = 01 JAN 2011 </p><p>Cycle 1&gt;Day 1&gt;VISITDT = 05 JAN 2011 then DaysDiff is derived with </p><p>4 </p><p>Cycle 2&gt;Day 1&gt;VISITDT = 21 JAN 2011 then DaysDiff will be derived </p><p>with 20 in Cycle 2&gt;Day 1 and also affect the value in Cycle 1&gt;Day 1 </p><p>folders </p><p>Requirement: </p><p>Enter: </p><p>Given: </p><p>Example: </p><p>Cycle is repeated in folder: Cycle 1, Cycle 2, , Cycle n Day 1, Day 8 and Day 15 are the folders &amp; exist in all cycles </p><p>Derivation is a form &amp; exists in Day 1, Day 8 and Day 15 folders </p></li><li><p>Proprietary and confidential </p><p>11 Rave Custom Functions October 11h 2011 </p><p>Custom Functions - Solutions adapted to your Complex Study Protocol Requirements - </p></li><li><p>Proprietary and confidential </p><p>12 Rave Custom Functions October 11h 2011 </p><p>Basic Concepts of Custom Functions </p><p> What is a custom function in Rave? </p><p> Custom Function defines the business logic implemented on an eCRF </p><p> 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 </p><p> What experience is needed to develop custom functions? </p><p> Study build experience with Rave </p><p> Good knowledge in object oriented programming concepts </p><p> Good knowledge of C# and SQL programming </p></li><li><p>Proprietary and confidential </p><p>13 Rave Custom Functions October 11h 2011 </p><p>Benefits of Custom Functions </p><p> Dynamic query messages and search lists </p><p> Configurable AE/SAE emails </p><p> Role/user based emails </p><p> Adding/inactivating of forms/folders/matrices </p><p> Copying data </p><p>Improved Data Accuracy </p><p>Faster Study Build </p><p>Flexibility allowing more </p><p>Customization </p><p> Configuration of dynamic protocol requirements: </p><p> Adding required number of records </p><p> Visible/invisible fields </p><p> Data comparisons/validations </p><p> Standard CFs can be reused for future study builds </p><p> Etc. </p></li><li><p>Proprietary and confidential </p><p>14 Rave Custom Functions October 11h 2011 </p><p>Categories of Custom Functions </p><p>Custom Functions (CFs)can be categorized into: </p><p> Simple CFs </p><p> Moderate CFs </p><p> Complex CFs </p></li><li><p>Proprietary and confidential </p><p>15 Rave Custom Functions October 11h 2011 </p><p> Simple custom functions </p><p> Very simple business logic </p><p> Applied on a single form </p><p>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 Etc. </p><p>Example: Add a form in the same folder </p><p>Categories of Custom Functions </p></li><li><p>Proprietary and confidential </p><p>16 Rave Custom Functions October 11h 2011 </p><p> Moderate Custom Functions </p><p> Comparison of multiple forms </p><p>Example: Display query message or place a sticky based on data from multiple forms </p><p>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 Etc. </p><p>Categories of Custom Functions </p></li><li><p>Proprietary and confidential </p><p>17 Rave Custom Functions October 11h 2011 </p><p> Complex Custom Functions </p><p> Comparison of multiple forms </p><p> Requires SQL script </p><p>Example: Generating sequential patient or randomization numbers </p><p>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 Etc. </p><p>Categories of Custom Functions </p></li><li><p>Proprietary and confidential </p><p>18 Rave Custom Functions October 11h 2011 </p><p>Best Practices - Around the use of Custom Functions - </p></li><li><p>Proprietary and confidential </p><p>19 Rave Custom Functions October 11h 2011 </p><p> Use header below to identify and trouble shoot a CF: </p><p> Check for NULL objects </p><p> Check Active status of all objects </p><p> Avoid using try-catches because Rave does it for you </p><p>Best Practices </p></li><li><p>Proprietary and confidential </p><p>20 Rave Custom Functions October 11h 2011 </p><p> Keep the code simple and readable </p><p> but if you want to improve system performance: </p><p> Use OIDs rather than names </p><p> Avoid using foreach </p><p> Avoid writing nested for loops </p><p> Loop handling: </p><p> Avoid sending emails in a loop </p><p> Remember to breakout the loop when search is completed </p><p> Email Handling: </p><p> Check the environments before sending an email </p><p> Avoid using same email ID for different environments </p><p> Stored Procedure Handling: </p><p> Use SQL stored procedures instead of dynamic SQL </p><p> Avoid stored procedures for updates or deletions </p><p>Best Practices </p></li><li><p>Proprietary and confidential </p><p>21 Rave Custom Functions October 11h 2011 </p><p>Q &amp; A </p></li><li><p>Proprietary and confidential </p><p>22 Rave Custom Functions October 11h 2011 </p><p>Marc Desgrousilliers </p><p>Chief Technology Officer </p><p>marc.desgrousilliers@clinovo.com </p><p>Venkat Sungishala </p><p>Sr. Manager of EDC </p><p>venkat.sungishala@clinovo.com </p><p>Upcoming webinars </p><p>Implementing adaptive clinical trials October 18th, 9 AM PST </p><p>CDISC Express Demo October 26th, 9 AM PST </p><p>www.clinovo.com </p><p>Follow us on twitter @clinovo </p><p>Contact Us </p></li><li><p>Proprietary and confidential </p><p>23 Rave Custom Functions October 11h 2011 </p><p>Thank You for your Attention ! </p><p>Visit our website for upcoming webinars: </p><p>www.clinovo.com </p></li></ul>

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