# Presentation: 527432

## Overview of Data Flow Scenario for Protocol Abstraction*

**Overview of Data Flow Scenario for Protocol Abstraction***

- *The data flow scenario assumes preconditions of the Protocol Abstraction Use Case 1.4 have been met (all appropriate institutional values for coded elements have been added, and user has searched/selected protocol).

**DFD 23 – **
**Protocol Abstraction: Assigned Protocol Personnel**

**or**

**DFD 20 – **
**Protocol Abstraction: Primary Sponsor, External and Internal Reporting Groups**

**DFS **
**Enter additional **
**Protocol **
**and Study **
**Participant **
**Data**

**DFS **
**Create AE**

- DFD 3 –
- Protocol Management

**DFD 27 – **
**View List of Study Participants Enrolled on Protocol**

**DFD 26 – **
**Protocol Abstraction: General Information**

**DFD 21 – **
**Edit Primary Sponsor**

**DFD 22 – **
**Assign External or Internal Reporting Group(s)**

**or**

**DFD 24 – **
**Edit Protocol Personnel**

**DFD 25 – **
**Assign Protocol Personnel**

**or**

**and**

**and**

- caAERSProtocolAbstraction_2005v2

## Protocol: 01006 - Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma (CTCAE v 3.0)

**Protocol: **01006 -** ***Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma (CTCAE v 3.0)*

**Protocol Abstraction**

_**View List of Study Participants Enrolled on Protocol**_

**4**

**Data Flow Display 3 – Protocol Management **(Select “Protocol Abstraction: Primary Sponsor...”)**	**

**1**

**2**

**4**

**3**

_*caAERS*__*SM*__ Home Page_

- The system allows the user to select various options for managing the displayed protocol.  Navigate to Protocol Management via caAERS Home Page or protocol search function.

- The user may select this hot link to assign, edit or enter additional data for protocol-level personnel. Display is in progress.

- The user may select this hot link to manage the entities associated with the displayed protocol.  Entities include: primary sponsor external and internal reporting groups.  Refer to UC 1.4

- The user may select this hot link to view a list of study participants enrolled on the displayed protocol.

**1**

_**General Protocol Information**_

_**Primary Sponsor, External and Internal Reporting Groups**_

**2**

**3**

_**Protocol Personnel**_

- General protocol abstraction display is in progress.

- caAERSProtocolAbstraction_2005v2

## Protocol 01006 – Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed / Refractory Multiple Myeloma (CTCAE v3.0)

**Protocol 01006** – *Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed / Refractory Multiple Myeloma (CTCAE v3.0)*

_*caAERS*__*SM*__ Home Page_

**DFD 20 – Protocol Abstraction: Primary Sponsor, External and Internal Reporting Groups (Use Case 1.4)**

**1**

- The displayed primary sponsor information is pre-filled as a result of the user entering this data during the “Create Protocol” scenario.  Additional information is now required and the user clicks “edit” to open a child window and complete data entry for the primary sponsor.  The system refreshes the protocol abstraction display upon completion of data entry.

**2**

- The user may assign one or more external reporting groups (as required by the protocol) and edit as necessary.  The user clicks “Add” to view entity options.  The system refreshes the protocol abstraction display upon completion of data entry.  The user may also choose to delete /remove the assignment of this entity to this protocol. (UC 1.4.2)

**3**

- The user may assign one or more internal reporting groups (as required by the protocol) and edit as necessary.  Both the “add” and “edit” functions access a child window for completion of data entry.  The system refreshes the protocol abstraction display upon completion of data entry.  This section displays a case where the user has already assigned the internal reporting group “COH IRB” to the protocol. The user may also choose to delete / remove the assignment of this entity to this protocol (UC 1.4.2).

**4**

- User may click “exit” to return to the Protocol Management display.

- The system displays all entities assigned to the named protocol, and allows the user to edit or delete existing information, and assign additional entities.  Entity options are derived from the protocol’s reporting requirements and are configured by the local system administrator.  Appropriate entities assigned to the protocol are required for the triggers to return accurate notifications to the user.

**Protocol**
_**ID#**_

- 01006

**Protocol **_**Version**_

**Protocol **_**Version Date**_

- 3

**1**

**2**

- 98153

- 3

- 05/15/2005

**3**

**Required **_**Review Date**_

- 12/30/2005

**Contact :**

- caAERSProtocolAbstraction_2005v2

## Additional Entity Information Required

- Lisa Smith – Expedited AEs
- Joan Johnson – AEs

**Additional Entity Information Required**

**Protocol 01006** – *Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma (CTCAE v3.0)*

**DFD 21 – Edit Primary Sponsor (Use Case 1.4.1)**

_**Contact Information**_

_**Primary Sponsor**_**  **

_**Sponsor Address**_

- 555 NW Lane
- Bethesda, MD 20857

**1**

**1**

- The system displays information previously entered about the primary sponsor.  These additional data entry fields are required in order for the triggers to return accurate information to the user, and to capture information required within the entity-specific adverse events report.

- The user selects the appropriate contact person from the drop down list, which is pre-configured by the local system administrator.  This configuration includes the contact person’s title, contact number, fax number and email address, and the data will populate in the field below the contact name.  Assigning a contact name to the protocol is optional.  User may elect to add multiple contact names to a sponsor.

**2**

**2**

- The primary sponsor name has been added by the user and the system displays the sponsor address, which is pre-configured by the local system administrator.

*Research Associate*
*303.555.1212*
*303.555.2222*
*Bjones@xyz.org*

**3**

- This field is pre-filled based on the user’s input of data during “Create Protocol”.  This is a required data entry field, but the user may edit the information if necessary.

**5**

- This field is pre-filled based on the user’s input of data during “Create Protocol”.  The user may edit this field and select a different protocol version from the drop down list.   This is an optional data entry field.

**6**

- The user may enter the protocol version date.  This is an optional data entry field.

**7**

- The user enters the sponsor’s required review data.  This is a required data entry field.

**8**

- The user clicks “Save” to save the data entered and return to the Protocol Abstraction display, which will reflect the user’s input.

*CTEP*

- (Mailing address for correspondence regarding adverse events)

- Reporting Methods

- _AE_

- _Expedited AE_

- Fax

- Email

- Mail

**3**

**4**

- For the contact person selected, the system will display the preferred reporting method for reporting AEs and Expedited AEs.  This is also pre-configured by the local system administrator.

- caAERSProtocolAbstraction_2005v2

## Additional Entity Information Required

**Additional Entity Information Required**

- Jay Leno - AEs
- Joan Johnson – Expedited AEs

- DCP

**Protocol 01006** – *Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma (CTCAE v3.0)*

**DFD 22 –Assign External or Internal Reporting Group to Protocol **(External Reporting Group)

- The system provides the user with a list of external reporting groups from which to consider assigning to the named protocol, based on that protocol’s reporting requirements.  This list is pre-configured by the local system administrator, and corresponds with the contact name options available in the drop down list – also configured by the local system administrator.

**1**

**Required Review Date :**

**Entity Protocol ID# :**

**4**

**5**

**Entity Protocol**
**Version :**

**Protocol Version**
**Date :**

**6**

**7**

**8**

_**External Reporting Group**_

_*caAERS*__*SM*__ Home Page_

_**Contact Information**_

*Research Monitor*
*301.555.1212*
*301.555.2222*
*Bsmith@xyz.org*

_**External Reporting Group Address**_

- 555 NW Lane
- Bethesda, MD 20857

**1**

- The user may select a contact person from the external reporting group’s drop down list.  This pre-configured item includes the contact person’s title, contact number, fax number and email address, which will populate in the field below contact name.  Assigning a contact person is optional; the user may also assign multiple contacts to an external reporting group.

**2**

- From the drop down list, the user selects the appropriate external reporting group.  The corresponding address will populate in the field below.

**4**

**5**

- The user enters the external reporting group’s protocol ID number.  This is a required data entry field.

**6**

- The user may select a protocol version from the drop down list; however, this is an optional data entry field.

**7**

- The user may enter the protocol version date.  This is an optional data entry field.

**8**

- The user enters the external reporting group’s required review date.  This is a required data entry field.

- The user clicks “Save” to save the data entered and return to the Protocol Abstraction display, which will reflect the user’s input.

**2**

- (Mailing address for correspondence regarding adverse events)

- Reporting Methods

- _AE_

- _Expedited AE_

- Fax

- Email

- Mail

**3**

**3**

- For the contact person selected, the system will display the preferred reporting method for reporting AEs and Expedited AEs.  This is also pre-configured by the local system administrator.

- caAERSProtocolAbstraction_2005v2

## ROLE:

**2**

**4**

**5**

**6**

**3**

- Principal Investigator is pre-filled from user input during “Create Protocol”.  The user clicks “edit” to select the PI’s department, which will automatically generate the title, phone, fax, and email for the PI.

- The system displays pre-filled fields (italicized text) allowing the user to view previously entered information.  The user may add or edit data where indicated.

**7**

_*caAERS*__*SM*__ Home Page_

- Multiple co-investigators may be assigned to a protocol by clicking “add”.  This display assumes that the user has identified the co-investigators’ names, but not Bill Doctor’s department.  The user clicks “edit” to select the appropriate department – the  combination of name and department produces the remaining information.

**Contact Site**_** (Department)**_

_**Title**_

_**Phone**_

_**Fax**_

_**Email**_

*Director, Biomedical Informatics*

*(626) 256-4673 ext 5555*

*(626) 256-5555*

*cdoctor@coh.org*

*Information Sciences*

_**ROLE:**_

**1**

**1**

- The roles that appear are based on the local institution’s workflow.  Some role labels are fixed (Principal Investigator), while others are flexible (“Protocol Nurse” at one institution could be the equivalent of “CRA” at another institution).  These roles are pre-configured by the local system administrator.

- The user clicks “add” to select the appropriate staff associated with these roles.  The staff’s contact information will automatically generate.  The “edit” function is grayed out until a name is associated/assigned.

**7**

- The user may exit this display and return to “Protocol Management”

- caAERSProtocolAbstraction_2005v2

## DFD 24 – Edit Protocol Personnel (Edit Principal Investigator)

**DFD 24 – Edit Protocol Personnel **(Edit Principal Investigator)

**Protocol 01006** – *Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed / Refractory Multiple Myeloma (CTCAE v3.0)*

**1**

_**Contact Site (Department)**_

- Hematology
- Medical Oncology

_**Site Principal Investigator**_

*John Doctor, MD*

**1**

- Principal Investigator is pre-filled from user input during “Create Protocol”.  The department options are filtered based on the PI name selected.  The options are limited to those departments with which the PI is affiliated.  The department chosen will automatically generate the contact information associated with the specific department.

**4**

_*caAERS*__*SM*__ Home Page_

**2**

**2**

**3**

**3**

**4**

- The user views the department options and selects the appropriate department from the drop down list.

- The system automatically generates the principal investigator’s title and contact information when the user highlights the associated department.

- The user clicks “save” to save the selected information in the caAERS system, and return to the display “Assigned Protocol Personnel” display.  The system refreshes the display to reflect the newly entered information.

- The system displays the edit function for principal investigator, as directed by the user.  The edit function allows the user to identify the department with which this principal investigator is affiliated for this particular protocol.

- caAERSProtocolAbstraction_2005v2

## DFD 25 – Assign Protocol Personnel (Assign Protocol Nurse)

**Protocol 01006** – *Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed / Refractory Multiple Myeloma (CTCAE v3.0)*

_**Protocol Nurse**_

**1**

_**Contact Site (Department)**_

*Pediatrics*

**1**

- The user selects the protocol nurse from the drop down list.

**4**

_*caAERS*__*SM*__ Home Page_

**2**

**2**

**3**

**3**

- The system displays the department with which the selected protocol nurse is affiliated.

- The system also automatically generates and displays the select staff’s title and contact information.

**4**

- The use clicks “save” to save the selected information and return to the “Assigned Protocol Personnel” display.  The system refreshes the display to reflect the information entered.

- The system displays the protocol personnel role: “Protocol Nurse”.  All roles (other than principal investigator and co-investigator) are labeled by the local system administrator, according to their workflow, and configured with appropriate staff/contact information.  The user must select the appropriate staff for this role, and the system provides all additional information, including department.  The same is required for protocol personnel roles for which the staff person is affiliated with only one department.

- caAERSProtocolAbstraction_2005v2

## 1

**1**

**4**

**5**

**6**

**DFD 26 – Protocol Abstraction: General Protocol Data **(from DFD 3)

**3**

- 01006 -** ***Phase II Randomized Trial of Bevacizumab Versus Bevacizumab and Thalidomide for Relapsed/Refractory Multiple Myeloma (CTCAE v 3.0)*

**Primary Sponsor Protocol ID |**
**Full Protocol Title :**

**1**

**2**

**Additional Protocol Information - CTEP**

**4**

_*caAERS*__*SM*__ Home Page_

- The user clicks “save” to save the entered data and return to the “Protocol Management” display.

- System displays data about the protocol entered by the user during “Create Protocol” and/or “Edit Protocol Personnel”.

- Based on the primary sponsor name entered during the create protocol phase, the system displays data entry fields specific to that entity’s data collection requirements for adverse event reporting.  User enters data – all fields are required.  The fields: “NCI Protocol Number” or “DCP Protocol #” would be pre-filled if they were identified as the primary sponsor during the create protocol phase.

**Additional Protocol Information - DCP**

**IND Sponsor :**
- (DCP) 2179647

**3**

**2**

- The user enters the IND#.

- The user enters the IND Sponsor name.  This will inform the system triggers regarding reporting requirements to FDA.

**4**

**5**

- caAERSProtocolAbstraction_2005v2

## Version History

- 10.20.2005: first draft of data flow scenario “Protocol Abstraction” for use case 1.4 – jln
- 10.21.2005: updated data flow scenario based on AE working group 10.20.05 feedback – jln
- DFD 3	All instances of “External Protocol Oversight Agency” replaced with “External Reporting Group” (DFD 3, DFD 20, DFD 22)
- 	All instances of “Institutional Review Committee” replaced with “Internal Reporting Group” (DFD 3, DFD 20, DFD 22)
- DFD 20	Deleted data entry field: “Entity ID #”
- 	Added contact display field to illustrate that users may assign multiple contact persons for a single entity.
- DFD 21,22	Added functionality to add/assign another contact for a specific entity
- 	Removed data entry field “Entity ID #”
- 	Added contact person’s preferred reporting method for specified report type: expedited and non-expedited
- 	Added categories of adverse event reports reviewed by each contact person: Expedited, Non-Expedited, and All
- 10.25.2005:	2nd version of data flow scenario – jln
- DFD 23-26	Added displays for viewing assigned protocol personnel, editing protocol personnel and assigning protocol personnel.
- 	Added protocol abstraction for general information.

- caAERSProtocolAbstraction_2005v2