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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  • Clinovo 1208 E. Arques Avenue, Suite 114 Sunnyvale, CA 94085 contact@clinovo.com +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

    Todays 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

  • Proprietary and confidential

    3 Rave Custom Functions October 11h 2011

    Todays 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 October 11h 2011

    Study Build in Rave - Streamlining your Clinical Trial Process -

  • Proprietary and confidential

    5 Rave Custom Functions October 11h 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 October 11h 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 October 11h 2011

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

  • Proprietary and confidential

    8 Rave Custom Functions October 11h 2011

    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

  • Proprietary and confidential

    9 Rave Custom Functions October 11h 2011

    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

  • Proprietary and confidential

    10 Rave Custom Functions October 11h 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 October 11h 2011

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

  • Proprietary and confidential

    12 Rave Custom Functions October 11h 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 October 11h 2011

    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.

  • Proprietary and confidential

    14 Rave Custom Functions October 11h 2011

    Categories of Custom Functions

    Custom Functions (CFs)can be categorized into:

    Simple CFs

    Moderate CFs

    Complex CFs

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    15 Rave Custom Functions October 11h 2011

    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

    Categories of Custom Functions

  • Proprietary and confidential

    16 Rave Custom Functions October 11h 2011

    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.

    Categories of Custom Functions

  • Proprietary and confidential

    17 Rave Custom Functions October 11h 2011

    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.

    Categories of Custom Functions

  • Proprietary and confidential

    18 Rave Custom Functions October 11h 2011

    Best Practices - Around the use of Custom Functions -

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    19 Rave Custom Functions October 11h 2011

    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

  • Proprietary and confidential

    20 Rave Custom Functions October 11h 2011

    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

  • Proprietary and confidential

    21 Rave Custom Functions October 11h 2011

    Q & A

  • Proprietary and confidential

    22 Rave Custom Functions October 11h 2011

    Marc Desgrousilliers

    Chief Technology Officer

    marc.desgrousilliers@clinovo.com

    Venkat Sungishala

    Sr. Manager of EDC

    venkat.sungishala@clinovo.com

    Upcoming webinars

    Implementing adaptive clinical trials October 18th, 9 AM PST

    CDISC Express Demo October 26

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