Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA Thursday, June 23 rd 2011 Medidata Rave® Custom Functions Webinar Implementing the Rave Custom Functions Best Suited to your Clinical Study Requirements

Proprietary and confidential 2 Rave Custom Functions June 23 rd 2011 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

Proprietary and confidential 3 Rave Custom Functions June 23 rd 2011 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

Proprietary and confidential 4 Rave Custom Functions June 23 rd 2011 Study Build in Rave® - Streamlining your Clinical Trial Process -

Proprietary and confidential 5 Rave Custom Functions June 23 rd 2011 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

Proprietary and confidential 6 Rave Custom Functions June 23 rd 2011 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…

Proprietary and confidential 7 Rave Custom Functions June 23 rd 2011 Edit Checks and Derivations - Improved Data Cleaning, Faster Clinical Trial -

Proprietary and confidential 8 Rave Custom Functions June 23 rd 2011 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

Proprietary and confidential 9 Rave Custom Functions June 23 rd 2011 Limitations of Edit Checks and Derivations Do not support:  Dynamic folders  Form inactivation  Dynamic subject calendar  with specific fields data  Dynamic queries  Auto number generation  Chronological order of dates edit checks  Dynamic search list …… Do not support:  Complex mathematical algorithms  Data in different forms/folders  Specific derivations on variables shared across multiple forms …… Edit ChecksDerivations

Proprietary and confidential 10 Rave Custom Functions June 23 rd 2011 Limitations of Editchecks and Derivations 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 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 Requirement: Enter: Given: Example: 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

Proprietary and confidential 11 Rave Custom Functions June 23 rd 2011 Custom Functions - Solutions adapted to your Complex Study Protocol Requirements -

Proprietary and confidential 12 Rave Custom Functions June 23 rd 2011 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

Proprietary and confidential 13 Rave Custom Functions June 23 rd 2011 Benefits of Custom Functions  Dynamic query messages and search lists  Configurable AE/SAE s  Role/user based s  Adding/inactivating of forms/folders/matrices  Copying data Improved Data Accuracy Faster Study Build Flexibility allowing more Customization  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  …

Proprietary and confidential 14 Rave Custom Functions June 23 rd 2011 Categories of Custom Functions Custom Functions (CFs)can be categorized into:  Simple CFs  Moderate CFs  Complex CFs

Proprietary and confidential 15 Rave Custom Functions June 23 rd 2011 Categories of Custom Functions  Simple custom functions  Very simple business logic  Applied on a single form 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  … Example: Add a form in the same folder

Proprietary and confidential 16 Rave Custom Functions June 23 rd 2011 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  …

Proprietary and confidential 17 Rave Custom Functions June 23 rd 2011 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 s based on roles  Checking for uniqueness of the entered data  Dynamic search list  Multiple matrices  Nested folders  …

Proprietary and confidential 18 Rave Custom Functions June 23 rd 2011 Best Practices - Around the use of Custom Functions -

Proprietary and confidential 19 Rave Custom Functions June 23 rd 2011 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

Proprietary and confidential 20 Rave Custom Functions June 23 rd 2011 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 s in a loop  Remember to breakout the loop when search is completed  Handling:  Check the environments before sending an  Avoid using same ID for different environments  Stored Procedure Handling:  Use SQL stored procedures instead of dynamic SQL  Avoid stored procedures for updates or deletions

Proprietary and confidential 21 Rave Custom Functions June 23 rd 2011 Q & A

Proprietary and confidential 22 Rave Custom Functions June 23 rd 2011 Thank You for your Attention ! Visit our website for upcoming webinars:

Proprietary and confidential 23 Rave Custom Functions June 23 rd 2011 Contact Clinovo 1208 E Arques Ave. Suite 114 Sunnyvale, CA Marc Desgrousilliers, VP of Operations Venkat Sungishala, Sr. Manager of EDC