Medidata Rave® Custom Functions

Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 [email protected] +1 800 987 6007 www.clinovo.com

Tuesday, October 11th 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 October 11h 2011

Today’s Speakers

Venkat Sungishala - Sr. Manager of EDC

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 – Chief Technology Officer

Experience: 20+ years experience in software and engineering



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



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



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



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…



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



Edit Checks and Derivations

What are Edit checks?

Logic rule applied to a field in a eCRF

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



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

Etc.

Do not support:

Complex mathematical algorithms

Data in different forms/folders

Specific derivations on variables shared across multiple forms

Etc.

Edit Checks Derivations



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



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



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



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

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

Etc.



Categories of Custom Functions

Custom Functions (CFs)can be categorized into:

Simple CFs

Moderate CFs

Complex CFs



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 Etc.

Example: Add a form in the same folder




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 Etc.




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 Etc.




Best Practices - Around the use of Custom Functions -



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

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

Best Practices



Q & A



Marc Desgrousilliers

Chief Technology Officer

[email protected]

Venkat Sungishala

Sr. Manager of EDC

[email protected]

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