# Presentation: 005488

## Slide 1

| List of Data Flow Displays |  |
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## Overview Of Data Flow Scenario for Create AE*

**DFD 1-**
**Search Protocol or Study Participant**

**DFD 4-**
**Select Study Participant**

**DFD 2-**
**Select Protocol**

- *The Create AE data flow assumes preconditions of the Create Use Case have been met ( Actor log – in, Protocol and study participant created and linked).

**or**

**DFD 8-**
**Capture Minimum AE Data**

**DFD 6-**
**Select ‘View all AEs’ option**

**or**

**DFD 7 -**
**Select CTCAE Category / Term / MedRA Code or Search by key word **

- AE status = Created
- & Notification
- Trigger Invoked

**DFD 3-**
**Select Study Participant from a protocol’s list**

**DFD 9-**
**Possible Duplicate AE Warning**

**DFD 5-**
**Study Participant Management**

**DFD x-**
**Preexisting AE is amended**

**or**

**DFD 10 -**
**Select CTCAE Category / Term / from key word search results **

**or**

**DFS **
**Create **
**Protocol **
**& Study **
**Participant**

**DFD 18-**
**Confirmation of AE creation**

- DFD=Data Flow Display
- (refer to subsequent pages)

## Protocols can have more than 1 protocol ID. User enters a protocol ID.  System will need to search all entered IDs for the protocol. Reference UC 1.1 & 1.4. Exact match on data entered. NOT case sensitive.

**2**

**3**

**4**

**Data Flow Display 1- Search for Protocol (UC 13.5) or Study Participant (UC 13.6)**

- Sponsor Name:

- Protocol Identification Number:

**Search for a protocol**

**Search for a study participant by entering:**

- Study Participant Number:

**AND / OR**

**1**

**2**

**5**

- IDE #:

- IND #:

**4**

**3**

- Last Name:

- First Name:

**6**

**7**

**5**

**6**

**7**

- Protocol can have more than 1 sponsor. User will select from specified list. System will need to search all entered sponsors. Reference UC 1.1 & 1.4.

- User enters alphanumeric protocol IND# if applicable as protocol search criteria

- User enters alphanumeric protocol IDE# if applicable as protocol search criteria.

- User executes search. System validates for minimum search criteria.

- User may enter alphanumeric study participant number as search criteria. System will need to search all entered study participant IDs. Exact match on data entered. NOT case sensitive.

- User may enter study participant first name and/or last name as search criteria

## User selects protocol ID hot link to select the interested protocol from search results.

## User selects study participant ID hot link to select the interested study participant from protocol list.

## User selects study participant ID hot link to select the interested study participant from search results.

## User may select the protocol hot link to view or edit the protocol

**1**

**2**

**3**

**4**

- User may select this hot link to view or edit the study participant’s data.

- User selects this hot link to view all adverse events recorded on the study participant.

- User selects this hot link to create a new adverse event for the study participant.

## User may create a new adverse event after viewing all adverse events recorded on the study participant for this protocol.  This is to assist the user in determining if AE is ‘preexisting’.

**Data Flow Display 6 –Select ‘View all AEs’ option**

**Study Participant : **Elmer Fudd

- AE Start Date

- Report Number

- Report Type - #

- Report Status

- 07/16/2005

- 235964

- Amended- 1

- Submitted to CTEP, FDA, IRB

- List of AEs

- Neutropenia

- Hemoglobin

- 07/16/2005

- 235964

- Original - 0

- Submitted to CTEP, FDA, IRB

- Neutropenia

- Hemoglobin

- Grade

- 2

- 2

- 4

- 4

- _Create a New Adverse Event_

**1**

**1**

- _Exit_

**2**

**2**

- User may exit and Not create a new AE.

## User selects CTCAE category when creating an adverse event. The CTCAE Term options are specific to the CTCAE category.  The associated MedDRA code populates on input of a category-term pair.

**CTCAE Category:**

**CTCAE Key**
**Word Search:**

**CTCAE Term:**

**MedDRA code:**

**Data Flow Display 7 –Select ‘Create a New AE’ option**

**2**

**4**

**3**

**1**

**1**

**2**

**4**

**3**

- User may alternatively input the MedDRA code when recording a new adverse event for a study participant. The associated CTCAE category and term will populate.

- User selects CTCAE term when creating an adverse event. The CTCAE term selection is limited to the CTCAE category selected. The associated MedDRA code populates on input of a category-term pair.

- User may input a key word to search for associated category-term pairs.

**OR**

## CTCAE category / Term and MedDRA code are pre-populated. Refer to DFD 7 

**Data Flow Display 8 – Capture Minimum AE Data**

**Study Participant : **Elmer Fudd

- Blood / Bone Marrow

**CTCAE Category :**

**Grade :**

- Neutropenia

**CTCAE Term :**

- 10293847

**MedDRA code :**

**1**

**2**

**3**

**2**

**3**

**1**

- CTCAE category / Term and MedDRA code are pre-populated. Refer to DFD 7

- User enters the date the AE was detected.  Refer to Use Case 1.5

- User enters the severity grade of the AE.  0-5 scale.

- This is the minimum data to create an AE in the system.  Additional data to collect about the AE is dependent on who the AE needs to be reported and if serious.

**AE Detection Date :**

- 7/20/2005

## ALERT:   Possible Duplicate Adverse Event

**Protocol: **_***32906***_ -** ***Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma (CTCAE v 3.0)*

**Study Participant : **Elmer Fudd

- AE Start Date

- Report Number

- CTCAE Category

- CTCAE Term

- 07/16/2005

- _235964_

- Blood / Bone Marrow

- Neutropenia

- Grade

- 2

- 6/25/2005

- _487209_

- Blood / Bone Marrow

- Neutropenia

- 3

**ALERT:   Possible Duplicate Adverse Event**
**The AE(s) below match with the AE you are attempting to register.**

**2**

**3**

**1**

- User may click on the report hot link to view the report associated with the AE.

- System will check for possible duplicate AEs for this study participant on this protocol.  Duplicate check criteria – CTCAE category and term pair.  Refer to Use Case 1.5

- User may choose to continue creating a new AE.

- User may choose to exit and NOT create an AE.

**1**

**2**

**3**

## Confirmation of AE Creation

**Confirmation of AE Creation**

**Data Flow Display 19  - Confirmation of AE Creation**

**Protocol: **_***32906***_ -** ***Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma (CTCAE v 3.0)*

**Study Participant : **Elmer Fudd

- Blood / Bone Marrow

**CTCAE Category :**

- Neutropenia

**CTCAE Term :**

**1**

**Adverse Event Status : **Created on 9/20/2005

**1**

- User may choose to complete data entry for the AE or exit

- This is a confirmation that the AE has been created in the system.

## Version History

**8.23.2005 – first draft of data flow scenario for ‘Creation AE’ Use Case 1.5  -  Screen # 3, 4, 5, 6, 7 (Main Menu Page, Search for Patient, Search for Protocol, View AE History, Search CTCAE term, Create New AE - CLS**