PeopleSoft Enterprise Grants 9.1 PeopleBook

Setting Up and Maintaining Protocol Management

This chapter provides an overview of protocol management setup and discusses how to:

Establish protocol controls.
Administer protocol workflow.

Understanding Protocol Management Setup

Protocol Management provides an automated system that enables you to document and amend human and animal protocols, and to manage the necessary approving authority approval processes. Protocol approving authorities include the Institutional Review Board (IRB) and the Institutional Animal Use and Care Committee (IACUC).

This section discusses:

Workflow actions.
Protocol workflow.
Committee setup.

Workflow Actions

You can workflow notifications about actionable protocol events to various individual , such as email notifications of committee meeting dates and agendas to committee members and dispositions to the PI. You can use workflow to automatically monitor protocol compliance, report dates, expirations, and upcoming renewals. Workflow can help you create all committee components, such as members, administrators, institutional officer, disposition, agenda, and meeting minutes.

Protocol Workflow

The system triggers workflow through user actions such as clicking a submit button, through running a scheduled batch process , or when certain conditions are met, such as a protocol expiring. Based on a predetermined set of contact roles and the rule conditions for when to contact users, workflow sends an email notification, worklist, or both. You can configure both rules and roles to capture as many people and events or scenarios as your business process requires.

See Setting Up the Approval and Notification Process.

Committee Setup

Some large research institutions have multiple animal and human protocol committees and, therefore, need the ability to distinguish one from another as well as distinguish between their respective activities. Protocol Management enables you to define more than one committee on the Committee Setup page.

Establishing Protocol Controls

To establish protocol controls, use these components:

Approving Authority (GM_PCL_APAU)
Protocol Type (GM_PCL_TYPE)
Genus (GM_PCL_GENUS)
Species (GM_PCL_SPECIES)
Strain, Subspecies (GM_PCL_STR)
Agent ( GM_PCL_AGENT)
Committee Administrator (GM_PCL_COM_ADMN)
Detail Type (GM_PCL_DTL_TYPE)
Committee Setup (GM_PCL_COM)
Committee Meeting Setup (GM_PCL_COM_MEET)
Grants Role Type (GM_PROF_ROLE_TYPE)

This section explains how to establish protocol controls and discusses how to:

Create protocol types.
Create a committee.
Define committee meetings.
Define grants rate types.

Pages Used to Establish Protocol Controls

Page Name	Definition Name	Navigation	Usage
Approving Authority	GM_PCL_APAU	Set Up Financials/Supply Chain, Product Related, Grants, Approving Authority	Use this page to identify the approving authority associated with the delivered protocol management functionality. Information entered here is used on the Hazardous Agents (GM_PCL_HAZA) page.
Protocol Type	GM_PCL_TYPE	Set Up Financials/Supply Chain, Product Related, Grants, Protocol Type	Create protocol types.
Genus	GM_PCL_GENUS	Set Up Financials/Supply Chain, Product Related, Grants, Genus	Set up genus codes.
Species	GM_PCL_SPECIES	Set Up Financials/Supply Chain, Product Related, Grants, Species	Set up species codes.
Strain, Subspecies	GM_PCL_STR	Set Up Financials/Supply Chain, Product Related, Grants, Strain, Subspecies	Set up strain, subspecies codes.
Agent	GM_PCL_AGENT	Set Up Financials/Supply Chain, Product Related, Grants, Agent	Set up agent codes.
Committee Administrator	GM_PCL_COM_ADMN	Set Up Financials/Supply Chain, Product Related, Grants, Committee Administrator	Set up committee administrator data.
Detail Type	GM_PCL_DTL_TYPE	Set Up Financials/Supply Chain, Product Related, Grants, Detail Type	Set up detail type data.
Committee Setup	GM_PCL_COM	Set Up Financials/Supply Chain, Product Related, Grants, Committee Setup	Create a committee.
Notes	GM_PCL_COM_NOTES	Click the Notes button on the Committee Setup page.	Enter notes about the committee members.
Details	GM_PCL_COM_MEM_DTL	Click the Address button on the Committee Setup page.	View email and telephone information for the committee member.
Committee Meeting Setup	GM_PCL_COM_MEET	Set Up Financials/Supply Chain, Product Related, Grants, Committee Meeting Setup	Enter a meeting date, time description, ID, and protocols.
Notes	GM_PCL_COM_M_NOTES	Click theNotes button on the Committee Meeting Setup page.	Add notes about the committee meeting.
Grants Role Type	GM_PROF_ROLE_TYPE	Set Up Financials/Supply Chain, Product Related, Grants, Role Types	Define role types. In addition to defining the roles, also define the types of areas where the role has applicability.

Creating Protocol Types

Access the Protocol Type page (Set Up Financials/Supply Chain, Product Related, Grants, Protocol Type).

Enter both a long and short description of the type of protocol, and then select a protocol sub type. Protocol sub types are system delivered values. There are only two values: Animal and Human. Each protocol type should be associated with a protocol sub type. Based on this association there is logic to hide/un-hide some fields on several protocol pages.

Creating a Committee

Access the Committee Setup page (Set Up Financials/Supply Chain, Product Related, Grants, Committee Setup).

This page defines the members of this particular committee along with the committee chair.

Committee ID	Displays a system generated ID.
Protocol Type	Select a protocol type from available values. Values may include: HUMN and ANIM.

Effective Date

Committee Chair

Select a committee chair from available values. Committee Chair should be part of the committee.

Committee Members

Member ID	Select a member ID from the list of available employee ID's.
Role Type	Select a value from the prompt table. Values may include: Scientist Non-scientist Community/Non-affiliated member Consultant Prisoner Representative Child Advocate Veterinarian Protocol Administrator Note. You can define role types and their applicability to different areas in PeopleSoft Grants on the Role Type page (GM_PROF_ROLE_TYPE).
Eligible to Vote	Select to indicate if the committee member is eligible to vote on protocols at full review meetings. On the Protocol Disposition page the Yes vote count must exceed the No vote count in order for you to change the Protocol to an Approved status.
	Click to enter any additional notes on the Notes page.
	Click to view email and telephone details on the Details page.

Defining Committee Meetings

Access the Committee Meeting Setup page (Set Up Financials/Supply Chain, Product Related, Grants, Committee Meeting Setup).

Max Num of Protocols (maximum number of protocols)

Enter the maximum number of protocols that can be scheduled for this meeting ID. When the meeting has reached the maximum number of protocols, the system will not allow you to add any more protocols to the meeting in the Protocol Administration page.

Notes

Click to enter notes about the meeting.

Defining Role Types

Access the Grants Role Type page (Set Up Financials/Supply Chain, Product Related, Grants, Role Types).

Define the role types. In addition to defining the roles you can also define the types of areas where the role have applicability.

Note. Certain Grants delivered workflow types only support a fixed list of roles, thus the role types of Award, Component, Milestone, and Other should not be modified by the user. Only the roles of Professional and Protocol can be defined by the user using the Grants Role Type page.

Administering Protocol Workflow

This section discusses how to review and administer protocol workflow.

Page Used to Administer Protocol Workflow

Page Name	Definition Name	Navigation	Usage
Protocol Administration	GM_PCL_ADMIN	Grants, Protocols, Protocol Administration	Administer all pending and submitted protocols that have not yet been acted against.

Reviewing and Administering Protocol Workflow

Access the Protocol Administration page (Grants, Protocols, Protocol Administration).

When you have established all the rules, the workflow tool is ready to automatically send notifications. When you submit the protocol, this action sends the initial workflow worklist to the committee administrator. The worklist includes a link to the Protocol Administration page. This page displays all pending (or submitted) protocols that have not yet been acted against. After the administrator acts on it, it is removed from the worklist. Also, the list that the administrator sees on the worklist email is the same list that is viewable from the Protocol Administration page. From this page, the administrator can decide and act on the individual protocols.

Protocol Sub Type	Select the subtype that you want to retrieve. Values include Human or Animal. This field has security that allows limited access. If the operator ID allows only for Animal, then only that value displays and is not available for editing. Users with access to all can edit the field.
Protocol Status	Select the status that you want to retrieve. In most instances, the committee administrator retrieves protocols with a status value of Pending. Pending is the only status value for which the Administration tab on this page is operable.

Information Tab

Protocol ID	Displays the Protocol ID.
Version	Displays the Version.
Protocol Version	Click the Protocol Version button to go to the version.
Submit Date	Displays the date on which the disposition was submitted.

Administration Tab

Review Type Assigned	Select Exempt, Expedited or Full Review.
Committee ID	Select a value from the list of available committee IDs that have the same protocol type. If a committee must review a protocol select the committee ID responsible for the review here.
Description	Displays a short descriptive name for the committee.
Meeting ID	Select a meeting ID. The prompt table enables you to see both the ID and associated date.
Returned by Reviewer	Displays this field as selected if one of the approvers returned this protocol.
Notify	Click this button to create the approval record and to trigger the workflow.

Max Num of Protocols (maximum number of protocols)	Enter the maximum number of protocols that can be scheduled for this meeting ID. When the meeting has reached the maximum number of protocols, the system will not allow you to add any more protocols to the meeting in the Protocol Administration page.
Notes	Click to enter notes about the meeting.