PeopleSoft Enterprise Grants 9.1 PeopleBook

Preparing and Submitting a Protocol

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

Maintain protocol information.
Enter protocol data.
Maintain committee meetings and dispositions.
Copy protocols and versions.

Understanding Protocol Management

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.

This section discusses:

Protocol architecture.
Rules for status and phase types.

Protocol Architecture

The Protocol Management architecture has two levels: header and version. There is a header level and a child version level. Header information remains static regardless of the many modifications, reviews, or renewals that the protocol undergoes in its full life cycle. Version information may change frequently; therefore, copy version functionality is necessary to avoid manually reentering data into the next version as well as to retain history. The distinction between these levels enables maximum flexibility in copying versions and in tracking changes between versions, which is essential to protocol management.

Rules for Status and Phase Types

A protocol undergoes a series of phases during its life. The system captures phases at the version level through the phase type. A protocol moves from one phase to the next by way of version creation. Only one version can govern at any one time and is considered the current version. By viewing the versions in relation to one another on the version grid, you can determine the history and flow of the protocol life. Phases and versions follow these rules:

The system creates the initial, new protocol header with a version of phase type New and status of Draft.

You cannot add or copy versions at this stage.
When you submit the protocol version, the status changes to Pending.

You cannot copy this version until the status changes to Approved or Returned.
If the disposition is issued as approved, the status also changes to Approved.

You can now copy the protocol version.
If the disposition is issued as returned, the status also changes to Returned.

You can now copy the protocol version.

Note. You can copy any protocol that is in any status. The status of the new copied protocol is always reset to Draft. You can copy a protocol version only when the status is Approved or Returned.

Note. Restrictions exist for copying a protocol version. A protocol is copied to a brand new protocol within the same protocol type. For example, animal to animal and human to human.

This table describes the seven protocol management statuses:

Status	Description
Draft	The version is added or copied, but not submitted.
Pending	The draft version is submitted for the review process.
Approved	The pending version is reviewed and approved by the reviewing authority.
Denied	The pending version is reviewed and denied by the reviewing authority. You can only copy this protocol to a new protocol.
Returned	The pending version is reviewed and returned for further modifications by the reviewing authority.
Expired	The version is approved and has expired because the project end date has passed.
Inactive	The version is submitted for the review process but no action was taken against it.

The version level status reflects the status for the entire protocol (for example, header) as only one version governs at any given time. Carrying the status at the version level allows for maximum flexibility when you are creating the various phase type protocol versions.

The phase type enables you to track the submissions and re-submissions of the various phases of the protocol. The reviewing committee must be able to track such changes to make their final approval as well as for ongoing reviews and reporting. A phase type, along with the status, helps identify which phase the protocol is in. The phase types are:

New: Indicates a brand new protocol version.

This is the first phase.
Modified: Indicates changes or updates being made to either:
- An approved protocol version, which is initiated by the Principal Investigator (PI) (for example, a minor amendment).
- A pending protocol version that was returned by the review committee (for example, a clarification of methodology).
  
  The PI updates the modified version with appropriate changes and then resubmits it for approval.
Continuing Review: Indicates a scheduled review of how the protocol research is progressing.

The PI is responsible for informing the review committee of the progress for their approval.
Renewal: Indicates updates to the approved protocol so the protocol is renewed or extended.

You can copy a protocol nearing its end date to a new version and reenter a new start and end date.

Note. You can also create a new protocol ID for this purpose. By copying a version, however, you have the advantage of retaining the link with the previous approved protocol period and header.

This table shows the rule set for how the phase type and status, along with other fields, interact and change the state of the protocol:

Phase Type	Original Status	Approval, Denied, and Returned Dates Populated	Status Changed To	Description	Status Change Trigger
New	Draft	N/A	Pending	You submit a new draft protocol for review.	Click the Submit button. The system enters a value into the Submitted Date field and changes the status to Pending.
New	Draft	N/A	Inactive	You create a new protocol, but no action is taken against it.	Run batch process for statuses remaining in Draft, Pending, and Returned status for a long time. Proceed with a follow-up action, such as changing the status to Inactive.
New	Pending	Yes/Denied	Denied	The committee review denies approval.	Committee review issues a disposition of Denied, and the system updates the Disposition Date field and changes the status to Denied.
New	Pending	Yes/Returned	Returned	The committee review requests changes to a protocol.	Committee review issues a disposition of Returned. The system updates the Returned On Date field and changes the status to Returned. You must now create a modified type version and resubmit that version.
New	Pending	N/A	Inactive	You submit the protocol to the committee for review; however, no action is taken against it.	Run batch process for statuses remaining in Draft, Pending, and Returned status for a long time. Proceed with a follow-up action, such as changing the status to Inactive.
New	Pending	Yes/Approved	Approved	The protocol is submitted, reviewed, and approved.	Committee review issues a disposition of Approved. The system updates the Disposition Date field and changes the status to Approved.
New	Approved	N/A	Expired	An approved protocol expires because the project end date has passed.	The system changes the status when a scheduled batch process runs.
New	Returned	N/A	Inactive	The committee returns the protocol for further modification; however, no action is taken against it.	Run batch process run for statuses remaining in Draft, Pending, and Returned status for a long time. Proceed with a follow-up action, such as changing the status to Inactive.
New	Denied	N/A	N/A	The committee denies the protocol.	You cannot change this status. The system stops the status flow process and captures the status for recording purposes.
New	Inactive	N/A	N/A	The protocol is inactive because no action is taken against it.	You cannot change this status. The system stops the status flow process and captures the status for recording purposes.
New	Expired	N/A	N/A	The approved protocol expires.	You cannot change this status. The system stops the status flow process and captures the status for recording purposes.
Modified	Draft	1) N/A or 2) Yes/Returned	Pending	You copy an approved protocol to a modified version and resubmit it for review again. Alternatively, the committee requests amendments to a new protocol before its approval. You copy it to a modified version, update it , and then resubmit it for final approval.	Click the Submit button. The system then updates the Submitted Date field, and changes the status to Pending.
Modified	Draft	N/A	Inactive	See description for New.	See status change trigger for New.
Modified	Pending	Yes/Denied	Denied	See description for New.	See Status Change Trigger for New
Modified	Pending	Yes/Returned	Returned	See description for New	See status change trigger for New.
Modified	Pending	N/A	Inactive	See description for New.	See Status Change Trigger for New
Modified	Pending	Yes/Approved	Approved	See description for New	See status change trigger for New.
Modified	Approved	N/A	Expired	See description for New.	See status change trigger for New.
Modified	Returned	N/A	Inactive	See description for New.	See status change trigger for New.
Modified	Denied	N/A	N/A	See description for New.	See status change trigger for New.
Modified	Inactive	N/A	N/A	See description for New.	See status change trigger for New.
Modified	Expired	N/A	N/A	See description for New.	See status change trigger for New.
Renewals	Draft	N/A	Pending	See description for New.	See status change trigger for New.
Renewals	Draft	N/A	Inactive	See description for New.	See status change trigger for New.
Renewals	Pending	Yes/Denied	Denied	See description for New.	See status change trigger for New.
Renewals	Pending	Yes/Returned	Returned	See description for New.	See status change trigger for New.
Renewals	Pending	N/A	Inactive	See description for New.	See status change trigger for New.
Renewals	Pending	Yes/Approved	Approved	See description for New.	See status change trigger for New.
Renewals	Approved	Yes/Approved	Expired	See description for New.	See status change trigger for New.
Renewals	Returned	N/A	Inactive	See description for New.	See status change trigger for New.
Renewals	Denied	N/A	N/A	See description for New.	See status change trigger for New.
Renewals	Inactive	N/A	N/A	See description for New.	See status change trigger for New.
Renewals	Expired	N/A	N/A	See description for New.	See status change trigger for New.
Continuing Renewals	Draft	N/A	Pending	See description for New.	See status change trigger for New.
Continuing Renewals	Draft	N/A	Inactive	See description for New.	See status change trigger for New.
Continuing Renewals	Pending	Yes/Denied	Denied	See description for New.	See status change trigger for New.
Continuing Renewals	Pending	Yes/Returned	Returned	See description for New.	See status change trigger for New.
Continuing Renewals	Pending	N/A	Inactive	See description for New.	See status change trigger for New.
Continuing Renewals	Pending	Yes/Approved	Approved	See description for New.	See status change trigger for New.
Continuing Renewals	Approved	Yes/Approved	Expired	See description for New.	See status change trigger for New.
Continuing Renewals	Returned	N/A	Inactive	See description for New.	See status change trigger for New.
Continuing Renewals	Denied	N/A	N/A	See description for New.	See status change trigger for New.
Continuing Renewals	Inactive	N/A	N/A	See description for New.	See status change trigger for New.
Continuing Renewals	Expired	N/A	N/A	See description for New.	See status change trigger for New.

Maintaining Protocol Information

This section provides an overview of the maintain protocol header component and discusses how to:

Maintain protocol information.
Create attachments.

Understanding the Maintain Protocol Header Component

The maintain protocol header component captures static, header level protocol data, which remains consistent even if amendments, modifications, or renewals are created. This header component serves as the parent for version-level data. Parent and child architecture allows for maximum flexibility in design—for the copy functionality, the ability to associate multiple approved iterations of a protocol during its total life cycle. The Version History grid displays all versions for this protocol. You maintain history because each version, after being submitted, is locked down and becomes uneditable. Both human and animal type protocols share the same portal navigation to the General Information search and add page. They share the same underlying architecture; however, depending on the associated protocol subtype, various fields and pages become hidden or available.

Pages Used to Maintain Protocol Information

Page Name	Definition Name	Navigation	Usage
Maintain Protocol	GM_PCL_HDR	Grants, Protocols, Maintain Protocol, Maintain Protocol	Enter static, header-level protocol data.
Attachments	GM_PCL_HDR_ATT	Grants, Protocols, Maintain Protocol, Attachments	Enter static, header-level protocol data.

Maintaining Protocol Information

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

Protocol ID

Displays the system-generated protocol ID. The creation of a protocol ID always generates the initial new or draft version. The system uses a Next numbering scheme to get the next available number. Also, for copy or copy versions, attachments are not copied.

Protocol Type

Displays the protocol type selected on the Search/Add page. Values include ANIM and HUMN.

Short Title

Enter a short title.

Long Title	Enter a more descriptive title, as needed.
Abstract	Enter a summary of the overall project plan, or attach a document on the Attachment page.

Version List

Version	Click to go to a specific version component. Upon initial creation of the header, only version ID, phase type, and status data appear until you enter other data on the version component. When a Protocol Header is added, one new version is always created. Also, for the person who is creating the Header, a role of Authorized is added on the Protocol Version - Personnel page.
Phase Type	Displays the current protocol phase. A protocol has multiple phases in its life cycle, and these types identify which phase the protocol is in. Values include: New: Indicates a new protocol version that is in the first phase. Modified: Indicates changes or updates that are being made to 1) an approved protocol version that was initiated by a PI (for example, a minor amendment) or 2) a pending protocol version that was returned by the review committee (for example, a disposition requesting a clarification of methodology) for which the PI will make changes in preparation to resubmit for approval. Renewal: Indicates updates to approved protocol for the purpose of renewing or extending protocol research. In this case, you also update the start and end dates. Continuing Review: Indicates a scheduled review of how the protocol research is progressing. The PI is responsible for informing the review committee of the progress, for their approval. This schedule is predetermined by the institution and typically happens at intervals of no greater than a year.
Status	Displays the protocol status. System events update the field. Values include: Draft: Version is added but not yet submitted. Pending: Version is submitted (date and time stamped) for the review process. Approved: The pending version is reviewed and approved by the reviewing authority. Denied: The pending version is reviewed and denied by the reviewing authority. You cannot change this status. It captures indefinitely that this version was rejected. You can copy this protocol to a new protocol, but cannot act against it in any other way. Returned: The reviewing authority reviewed and returned the pending version for further modifications.
Expires On	Displays the date on which the protocol expires and the research ceases on human and animal subjects.
Submitted On	Displays the date and time when you clicked the Submit button on the Version page.
Disposition Date	Displays the date on which the reviewing authority recorded the disposition on the committee review components.
Review Type	Displays the type of review selected by the committee administrator. Values include: Exempt, Expedited, and Full.
Copy Version	Click to access the Copy Protocol Version page. The copy version enables you to create a new version within the same protocol.

Creating Attachments

Access the Attachments page (Grants, Protocols, Maintain Protocol, Attachments).

Number of Requests

The system automatically generates the number of requests.

Entering Protocol Data

This section provides overviews of protocol data entry, animal subject (IACUC) tasks, and human subject (IRB) tasks and discusses how to:

Create and submit version information.
Enter personnel data.
Enter human subject data.
Enter a subject justification.
Enter animal data.
Enter an animal justification.
Enter purpose, methods, and procedures.
Enter procedures.
Enter hazardous agents.
Enter U.S. Food and Drug Administration (FDA) approval information.
Enter euthanasia disposition.
Create attachments.

Understanding Protocol Data Entry

The Version Information component captures the majority of the protocol data that is required for the specific type of research involving human or animal subjects. Each subheading and table in this section represents a logical grouping of the data fields required in protocol management. In this component, the tabs represent the sub-groupings. The information in this component is created from a new proposal or copied from another version.

Understanding Protocol Approval

The Protocol Administrator submits the completed protocol. This action changes the protocol status to Pending and triggers workflow to send an email and/or a worklist to the roles defined on the Approval/Notification Process page. The Protocol Administrator can access the Protocol Administration page through a worklist or navigation to query the pending protocols in the system and assign one of three Review Types to the protocol. The Review Types are: Exempt, Expedited, and Full Review. When a protocol is assigned Full Review, the Protocol Administrator assigns a Committee ID and a Meeting ID.

If the Review Type is Exempt or Expedited, the system sends an email and/or a worklist to the first level of approvers. The approver approves, denies, or returns the protocol through the worklist, which triggers workflow to send emails about the protocol status. The approver can request the Protocol Administrator to change the Review Type or have someone else issue the disposition by sending a worklist to the Protocol Administrator.

If the Review Type is Full Review, the system sends email to all committee members. After the committee meets and decides the disposition, the Protocol Administrator enters the disposition using the Protocol Disposition page, which triggers workflow to send an email notification about the approval status.

Pages Used to Enter Protocol Data

Page Name	Definition Name	Navigation	Usage
Version Info (version information)	GM_PCL_VRSN	Grants, Protocols, Enter Protocol Detail	Enter overall version information that is pertinent to the administration of the protocol, and then submit the version.
Approval Status & History	GM_PCL_APPROVE	Click the Approval Status & History link on the Version Info page.	View the approval status and history of the protocol. This page is available for review types Exempt or Expedited after the protocol is submitted.
Approver Comments	GM_DCL_APP_COMMENT	Click the Comments button on the Approval Status & History page.	Add comments.
Faculty Advisor Details	GM_PCL_PI_DTLS	Click the Faculty Advisor Details link on the Version Info page.	Enter the name of and statement for the faculty advisor.
Study Location	GM_PCL_LOC	Click the Study Location link on the Version Info page.	Select the code for the study location. This page is available only for human protocols.
Adverse Event Details	GM_PCL_ADVRS_EVNT	Click the Adverse Events Details link on the Version Info page.	Enter a description of the adverse event.
Assurance Information	GM_PLC_ASSUR_INFO	Click the Assurance Information link on the Version Info page.	Enter an assurance ID, and approval and expiration dates. This page is available only for animal protocols.
Notification History	GM_PLC_WF_HIS	Click the Notification History link on the Version Info page.	View notification history.
Personnel	GM_PCL_PROF	Grants, Protocols, Enter Protocol Detail, Personnel	Enter role and affiliation details for personnel who are associated with the protocol.
Details	GM_PCL_PROF_DTLS	Click the Detail button on the Personnel page.	Enter departmental details, such as phone and email information, for personnel who are associated with the protocol.
Training	GM_PCL_PROF_TRN	Click the Training button on the Personnel page.	Enter all relevant training that each person received, including training date and a description of the training. This page is available only for Animal protocols.
Notes	GM_PCL_PROF_NOTES	Click the Notes button on the Personnel page.	Enter notes about associated personnel and the person's relationship with the protocol.
Subjects	GM_PCL_SUB	Grants, Protocols, Enter Protocol Detail, Subjects	Enter all data that is related to the subjects who are required to conduct this particular protocol project. Note. This page is available only for human protocols. It is hidden for animal protocols.
Subject Justification	GM_PCL_SUB_JUST	Click the Justification button on the Subjects page.	Enter details about the justification for the use of subjects for the protocol.
Certification of Compliance	GM_PCL_SUB_CERT	Click the Certification Compliance button on the Subjects page.	Enter a title and description for the certification of compliance.
Consent and Compensation	GM_PCL_SUB_CONS	Click the Consent and Compensation button on the Subjects page.	Enter contact and communication details for consent and compensation information that is required to be documented and provided to subjects.
Subject Risks and Benefits	GM_PCL_SUB_RIBE	Click the Risks and Benefits button on the Subjects page.	Enter a detailed explanation of the consent forms that the subjects sign. Note. If the subject type is Children, then enter specifics for obtaining consent from children. The attachment of the actual consent form is also required.
Animals	GM_PCL_ANM	Grants, Protocols, Enter Protocol Detail, Animals	Enter all data that is related to the animal subjects that are required to conduct this particular protocol project. Note. This page is available only for animal protocols. It is hidden for human protocols.
USDA Classification	GM_PCL_ANM_USDA	Click the USDA Classification button on the Animals page.	Enter details about the USDA (United States Department of Agriculture) classification.
Animal Justification	GM_PCL_ANM_JUST	Click the Justification button on the Animals page.	Enter details about the justification for the use of animal subjects for the protocol.
Certification of Compliance	GM_PCL_ANM_CERT	Click the Certification button on the Animals page.	Enter a title and description for the certification of compliance.
Facilities and Care	GM_PCL_ANM_CERT	Click the Facilities and Care button on the Animals page.	Enter detailed information about the facilities that are being used for this protocol.
Purpose, Methods & Procedure	GM_PCL_PROC	Grants, Protocols, Enter Protocol Detail, Purpose, Methods & Procedure	Enter detailed information about the purpose, methods, and procedure that are associated with the protocol.
Procedures	GM_PCL_OTHR_DTL	Click the Procedures link on the Purpose, Methods & Procedure page.	Enter detailed information about the procedures that are used in this protocol.
FDA Approval	GM_PCL_FDA	Click the FDA Approval Info link on the Purpose, Methods & Procedure page.	Enter detailed information about the FDA approval that is associated with this protocol.
Hazardous Agents	GM_PCL_HAZA	Click the Hazardous Agents link on the Purpose, Methods & Procedure page.	Enter detailed information about hazardous chemicals or materials that are used in this protocol.
Euthanasia/Disposition	GM_PCL_EUTH	Click the Euthanasia/Disposition link on the Purpose, Methods & Procedure page.	Enter detailed information about the method of euthanasia or disposition that is used in this protocol.
Attachments	GM_PCL_VRSN_ATT	Grants, Protocols, Enter Protocol Detail, Purpose, Attachments	Attach files that are associated with the protocol.

Creating and Submitting Version Information

Access the Version Info page (Grants, Protocols, Enter Protocol Detail).

Submit

Click the Submit button to initiate a submission for review. If you have not saved the component, a message appears asking whether you want to save and then submit. After the version is submitted, the button is not available, and the version is uneditable.

Approval Status & History

Click to view the approval status and history of the protocol. This option is available only for Review Type Assigned of Exempt or Expedited.

Phase Type

Displays the phase type. Values include:

New

Modified

Renewal

Continuing Review

Requested Review

Select the preferred review process. This field does not determine the final review process; however, it indicates the PI's preference. The field is informational only. Values include: Full, Expedited, and Exempt.

Start Date

Select the anticipated start date of the protocol project. This date typically matches or precedes the proposal start date . The disposition date, however, must precede the start date because the protocol approval is required before the actual start of the project.

Note. Changing the start date calculates the next Continuing Review date.

End Date

Select the anticipated end date of the protocol project. This date is the same as the expiration date of the protocol. For workflow, the scheduled batch process notifies all identified individuals about the protocol's expiration, based on the workflow rule setup.

PI Name (principal investigator)

Select the name of the employee who owns this particular proposal. In most cases, this individual is the PI on the PeopleSoft Grants proposal that is being drafted, with which this protocol will be associated. Entering the PI name will provide a default value for the Department field.

Department

Select the department that is associated with the protocol.

Student PI (student principal investigator)

Select this option if the PI is a student. If it is selected, then the Faculty Advisor Details link appears. For workflow, by selecting the Student PI check box and also submitting the protocol, you will notify the requisite parties about the action. The email will also include a link to the version.

Faculty Advisor Details

Click the Faculty Advisor Details link to access the Faculty Advisor Details page. The following elements appear:

Name

Select a faculty advisor name from the prompt table.

Faculty Advisor statement

Enter a long description.

Study Location

Select a study location code from the list of available values. This option is available only for human protocols.

Adverse Event

Select this option to indicate an adverse event. If it is selected, then the Adverse Event Details link appears. For workflow, by selecting the Adverse Event check box and also submitting the protocol, you will notify the requisite parties about the action. The email will also include a link to the version.

Adverse Event Details

Click to access the Adverse Event Details page. Enter a description of the adverse event.

Assurance Information

Click to access the Assurance Information page, where you can enter an assurance ID, and approval and expiration dates. This option is available only for animal protocols.

Notification History

Click to access the Notification History page, where you can view notification details.

Status Update

Status	Displays the current protocol status. Values include Approved Denied Draft Expired Inactive Pending Returned
Submitted On	Displays the date and time the protocol was submitted. The date and time is generated by the system when you click the Submit button on this page.
Review Type Assigned	Displays the Review Type selected by the committee administrator. This is the actual review that the protocol will undergo.
Committee	Displays the committee ID that was assigned by the committee administrator. The value appears only for full reviews.
Meeting ID	Displays the meeting ID and the date and time of the committee meeting that is assigned by the committee administrator. The value appears only for full reviews.
Next CR Date (next continuing review date)	Displays the date of the next continuing review. The system automatically supplies the next continuing review date by incrementing the number of months defined by the user on the Proposal Award setup page, from the start date. The Workflow Rule setup page looks to the next continuing review date to notify individuals on a specified number of days before the due date.
CR Duration (continuing review duration)	Displays the duration of the review using the number of months set up for human or animal types of protocols at the business unit level.

Comments

This is a free-form comment section for capturing any other relevant information. Add multiple comments with a date and time stamp.

Entering Personnel Data

Access the Personnel page (Grants, Protocols, Enter Protocol Detail, Personnel).

Details

Role	Select the role type of the person who is associated with this version.
Affiliation	Enter the person's academic, institutional, or corporate affiliation.
Detail	Click to enter departmental, email, and telephone information for this person.
Training	Click to enter all relevant training that each person received, including training date and a description of the training. Add multiple rows to capture all experience. The protocol system uses department-level security. This option is available only for animal protocols.
Notes	Enter notes specific to each person.

Entering Human Subject Data

Access the Subjects page (Grants, Protocols, Enter Protocol Detail, Subjects).

This page is available only for human protocols. It is not available for animal protocols. This page captures all data that is related to the subjects who are required to conduct this particular protocol project.

Details Tab

Subject Type

Select a subject type from the available values. The subject type determines which type-specific fields become viewable and actionable in the secondary pages. Values include:

Pregnant Women.
Prisoners.
Fetuses.
Children.
Other Vulnerable: Subjects who are not listed but need a more specific justification or certification.
General : Subjects from the general populace.

You can add each subject type only once in the grid.

Note. When you have a prisoner or child subject type, the system triggers workflow to selected individuals for review. Prisoners need a prisoner representative. Children need a child advocate.

More Details Tab

Justification	Click to enter a full justification for the subject type to be used for the research.
Certification of Compliance	Click to enter a title and explanation of the certification for the research.
Consent and Compensation	Click to enter contact and communication details for consent and compensation information that is required to be documented and provided to subjects.
Subject Risks and Benefits	Click to enter a description of the risk or benefit to be elaborated. Risks may include infection, use of placebos, expected discomfort, and known hazards. Benefits may include remission of illness or improved medical condition. Multiple rows can be added.

Entering a Subject Justification

Access the Subject Justification page (click the Justification button on the Subjects page, More Details tab).

Require Fetuses Ex Utero

Select this option if the child subject is an ex utero fetus. This option appears only if Fetuses is selected as the subject type. If you select this option, then enter certification of compliance information on the Certification of Compliance page. If this option is not selected, then the Require Dead Fetuses option becomes available.

Require Dead Fetuses

Select this option if the child subject is a dead fetus. If you select this option, then enter certification of compliance information on the Certification of Compliance page. If this option is not selected, then the Require Fetuses Ex Utero option becomes available.

Details

Title

Enter a short description of the justification. Add additional rows as required.

Justification

Enter a full justification for involving the particular subject type for this protocol research.

Entering Animal Data

Access the Animals page (Grants, Protocols, Enter Protocol Detail, Animals).

This page is available only for animal protocols. It is not available for human protocols. This page captures all data that is related to the animals that are required for this particular protocol.

Details Tab

Period	Enter which period this row's information applies to. This is a free-form text field.
Genus	Enter the animal's division of family (for example, Rattus).
Species	Enter the animal's division of genus (for example, Rattus norvegicus).
Strain, Subspecies, or Breed	Enter the animal's strain, subspecies, or breed.
Common Name	Enter the animal's common name of the animal (for example, Brown Rat).

More details Tab

Age	Enter the animal's age.
UOM (unit of measure)	Enter whether the age is indicated in terms of minutes, hours, days, months, or years.

Entering an Animal Justification

Access the Animal Justification page (click the Justification button on the Animals page, More Details tab).

Details

Proposed Usage	Enter an explanation of how you plan to use the animals.
Title	Enter a short description of the justification (for example, the rationale for using live animals).

Detail

Enter a justification for this protocol research.

Entering Purpose, Methods, and Procedures

Access the Purpose, Methods & Procedure page (Grants, Protocols, Enter Protocol Detail, Purpose, Methods & Procedure).

Purpose

Purpose	Enter the purpose of the research.
Background	Enter background related information; for example, how the research came about.

Methods and Procedures

Study Design Title	Enter a short description of the hypothesis, research questions, statistics, or other topics that are related to the research. Add additional rows and attach documents as needed.
Description	Enter study design details.
Procedures	Select this option and click the link to go to the Procedures page.
Hazardous Agents	Select this option and click the link to access the Hazardous Agents page.
FDA Approval Info (FDA approval information)	Select this option and click the link to access the FDA Approval page.
Euthanasia/Disposition	Select this option and click the link to access the Euthanasia/Disposition page.

Entering Procedures

Access the Procedures page (click the Procedures link on the Purpose, Methods & Procedure page).

Details

Type

Select a type and enter an explanation of the procedure. Type values include:

Additional
Alternate
Other
Surgery
Unusual

Entering Hazardous Agents

Access the Hazardous Agents page (click the Hazardous Agents link on the Purpose, Methods & Procedure page).

Details

Enter an explanation about the hazardous agents used in the protocol.

Agent ID	Select the Agent ID.
Approving Authority	Select the approving authority.
Decision Date	Enter the date the decision was made about the use of the hazardous agent.
Decision	Select the Decision status from Approved, Pending, and UnApproved.
Submit Date	Enter the date the hazardous agent was submitted to the approving authority.
Tracking Number	Enter the number used to track the hazardous agent.
Explanation of Use	Enter a description of how you use the hazardous agent.

Entering FDA Approval Information

Access the FDA Approval page (click the FDA Approval Info link on the Purpose, Methods & Procedure page).

Details

Type

Select IDE (investigational device exemption) or IND (investigational new drug).

Decision

Select Approved, Pending, or Unapproved.

FDA Decision Date

Enter the date on which the FDA approved or disapproved the decision.

Number

Enter the FDA decision number.

Submit Date	Enter the date on which the study plan was submitted for review.
Explanation	Describe the details of the FDA decision.

Entering Euthanasia and Disposition

Access the Euthanasia/Disposition page (click the Euthanasia/Disposition link on the Purpose, Methods & Procedure page).

Euthanasia/Disposition Method

Enter an explanation of the euthanasia or disposition method.

Creating Attachments

Access the Attachments page (Grants, Protocols, Enter Protocol Detail, Purpose, Attachments).

Requests

The system automatically generates the number of requests.

Maintaining Committee Meetings and Dispositions

This section provides an overview of committee meeting and disposition maintenance and discusses how to:

Review and record meeting agendas.
Enter a protocol disposition.
Record minutes
Add attachments.
View a protocol disposition.

Understanding Committee Meeting and Disposition Maintenance

Set up a meeting to review protocol. Set up a full meeting review to record votes on the protocol and to record minutes and add attachments. Then approve, deny, or return the disposition.

Overriding Protocol Dispositions by Using Permission Lists and the User Personalization Option

After a committee issues its disposition the system locks the disposition so that users cannot make any changes. PeopleSoft Grants delivers a user option called Override Protocol Disposition (GM_DIS_OR), which enables you to provide users with the ability to override a disposition. The system-delivered option is N (No).

To override protocol dispositions you must first enable the Override Protocol Disposition user option.

Select PeopleTools, Personalization, Personalization Options. Define Personalizations.
Select the Format tab.
Click Set Option Default Value for the GM_DIS_OR user option.

The system displays the Set Option Default Value page.
Enter Y in the Option Default Value.
Click OK.
Click Save.

To change the personalization options for a permission list:

Select PeopleTools, Security, Permissions & Roles, Permission Lists.
Select the permission list that is associated with the user who you want to enable to override protocol dispositions.
Select the Personalizations tab.
Select Option Category Level FIN and Option Category Group Portal Personalizations.
Click Edit Options.

The system displays the Personalization Permissions page.
Select Allow User Option for GM_DIS_OR user option.
Click OK.
Click Save.

Pages Used to Maintain Committee Meetings and Dispositions

Page Name	Definition Name	Navigation	Usage
Full Review Meeting	GM_PCL_MEET	Grants, Protocols, Full Review Meeting	View meeting dates, times, and the protocols that are assigned to those dates.
Full Review Meeting - Protocol Disposition	GM_PCL_DISP_FR	Click the Disposition button on the Full Review Meeting page.	Enter vote counts for a protocol disposition. Approve, deny, or return a protocol, and add comments as needed.
Minutes	GM_PCL_MEET_MIN	Grants, Protocols, Full Review Meeting, Minutes	Enter minutes, announcements, and review comments from the meeting.
Attachments	GM_PCL_MEET_ATT	Grants, Protocols, Full Review Meeting, Attachments	Attach all meeting related notes and documents rather than entering them directly on to the Minutes page.
Protocol Disposition	GM_PCL_DISPOSITION	Grants, Protocols, Protocol Disposition	View the status of an exempt or expedited protocol.
Workflow Notification	GM_PCL_WF_RUN_CNTL	Grants, Protocols, Workflow Notification	Run the Protocol Batch Notification process.

Reviewing and Recording Meeting Agendas

Access the Full Review Meeting page (Grants, Protocols, Full Review Meeting).

Meeting Schedule

Protocol

Click the Protocol link to see header-level protocol information.

Version

Click the Version link to see overall version information.

Disposition

Click to access the Protocol Disposition page.

Entering a Protocol Disposition

Access the Full Review Meeting - Protocol Disposition page (click the Disposition button on the Full Review Meeting page).

Attendees

Name	Displays the names of individuals associated with this particular committee. You can add non-committee members as guests. The system automatically makes guests ineligible for voting.
Role	Displays the role associated with the individual. You can select a role from available choices.
Eligible to Vote	Displays the voting eligibility of committee attendees.
Count	Select Yes, No, or Abstain for each voting member. The vote count appears.

Disposition

Select the appropriate value according to the vote count and the decision of the committee. If the Yes votes outnumber the No votes, then you can select Approved. If the No votes outnumber the Yes votes, then you can select Denied. You can select Returned for either vote outcome. The system prevents you from selecting Approved if the No votes outnumber the Yes votes and from selecting Denied if the Yes votes outnumber the No votes. The system triggers workflow when the committee issues the disposition. After the committee issues the disposition and saves the component the fields on this page become display-only.

Comments

Enter any comments here. Comments for returned dispositions carry forward to the Protocol header page.

Recording Minutes

Access the Minutes page (Grants, Protocols, Full Review Meeting, Minutes).

Use this page to enter minutes, announcements, and review comments from the meeting.

Adding Attachments

Access the Attachments page (Grants, Protocols, Full Review Meeting, Attachments).

Use this page to attach meeting related notes and documents.

Viewing a Protocol Disposition

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

View the status of the protocol disposition for protocols with a review type of Exempt or Expedited. The Protocol Disposition search page will not retrieve protocols having a full review meeting

Copying Protocols and Versions

This section provides overviews of how to copy a protocol and how to renew an approved protocol, and discusses how to:

Copy a protocol.
Copy a protocol version.

Understanding How to Copy a Protocol

Copy functionality enables you to have information automatically transferred to a new protocol or version, thereby avoiding duplicate manual entry. Choose from two options: 1) copy one protocol with its current version to a new protocol and version or 2) copy one version within a protocol to another version within that same protocol. The following table explains the rules by which you can copy values for protocol and version copying functionality:

Fields	Copy Protocol From	Copy Protocol To	Copy Version From	Copy Version To
Version	All versions can be copied. Select the version from the search page.	Next system-generated version ID.	The most current version (highest ID number) is automatically supplied as the copy from version.	Next system-generated version ID.
Status	All can be copied.	Draft only.	Only Approved and Returned statuses can be copied.	Draft only.
Phase Type	All can be copied.	New only.	All can be copied.	Any phase type.
Start/End Dates		Copied as is.		Copied as is.
Next CR Date		Copied as is.		If the phase type is CR, the system will not copy the FROM version's CR date, but it will automatically increment to the next CR date.
Submitted on Date		Will not be copied. Blank value initially.		Will not be copied. Blank value initially.
Review Type Selected		Will not be copied.		Will not be copied.
Disposition Date		Will not be copied. Blank value initially.		Will not be copied. Blank value initially.
Committee ID		Will not be copied. Blank value initially.		Will not be copied. Blank value initially.
Meeting ID		Will not be copied. Blank value initially.		Will not be copied. Blank value initially.
Comments		Will be copied as is.		Will be copied as is.
Attachments		Will not be copied.		Will not be copied.

Understanding How to Renew an Approved Protocol

When a project is extended or you are approved for more funding you may need to renew an approved protocol. You do this by copying the approved protocol to a Renewal type version, making the necessary updates and resubmitting to the committee for evaluation. The protocol undergoes the regular protocol creation and submission process, however it is treated as a renewal. The system sends email notifications to designated individuals who then initiate the renewal process.

Pages Used to Copy Protocols and Versions

Page Name	Definition Name	Navigation	Usage
Copy Protocol	GM_PCL_CPY	Grants, Protocols, Copy Protocol	Copy a protocol.
Copy Protocol Version	GM_PCL_VRSN_CPY	Grants, Protocols, Copy Protocol Version Click the Copy Version button on the Maintain Protocol page.	Copy a protocol version.

Copying a Protocol

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

From

Protocol ID	Displays the protocol ID that is selected on the search page.
Version	Displays the version that is selected on the search page.
Protocol Type	Displays the protocol type of the current open protocol.

Protocol ID

Displays NEXT to indicate the system-generated new ID number.

Version

Displays NEXT to indicate the system-generated new version number.

Protocol Type

Displays the protocol type.

Note. Restrictions apply to copying a protocol version. A protocol is copied to a brand new protocol within the same protocol type. For example, animal to animal and human to human.

Copying a Protocol Version

Access the Copy Protocol Version page (Grants, Protocols, Copy Protocol Version).

From

Protocol ID	Displays the protocol ID that is selected on the search page.
Version	Displays the version that is selected on the search page.
Protocol Type	Displays the protocol type.

Protocol ID	Displays the same protocol ID as the one that is selected on the Search page.
Version	Displays NEXT to indicate the system-generated new version number.
Protocol Type	Displays the protocol type.
Phase Type	Select Modified, Renewal, or Continuing Review.

Protocol ID	Displays the system-generated protocol ID. The creation of a protocol ID always generates the initial new or draft version. The system uses a Next numbering scheme to get the next available number. Also, for copy or copy versions, attachments are not copied.
Protocol Type	Displays the protocol type selected on the Search/Add page. Values include ANIM and HUMN.

Submit	Click the Submit button to initiate a submission for review. If you have not saved the component, a message appears asking whether you want to save and then submit. After the version is submitted, the button is not available, and the version is uneditable.
Approval Status & History	Click to view the approval status and history of the protocol. This option is available only for Review Type Assigned of Exempt or Expedited.
Phase Type	Displays the phase type. Values include: New Modified Renewal Continuing Review
Requested Review	Select the preferred review process. This field does not determine the final review process; however, it indicates the PI's preference. The field is informational only. Values include: Full, Expedited, and Exempt.
Start Date	Select the anticipated start date of the protocol project. This date typically matches or precedes the proposal start date . The disposition date, however, must precede the start date because the protocol approval is required before the actual start of the project. Note. Changing the start date calculates the next Continuing Review date.
End Date	Select the anticipated end date of the protocol project. This date is the same as the expiration date of the protocol. For workflow, the scheduled batch process notifies all identified individuals about the protocol's expiration, based on the workflow rule setup.
PI Name (principal investigator)	Select the name of the employee who owns this particular proposal. In most cases, this individual is the PI on the PeopleSoft Grants proposal that is being drafted, with which this protocol will be associated. Entering the PI name will provide a default value for the Department field.
Department	Select the department that is associated with the protocol.
Student PI (student principal investigator)	Select this option if the PI is a student. If it is selected, then the Faculty Advisor Details link appears. For workflow, by selecting the Student PI check box and also submitting the protocol, you will notify the requisite parties about the action. The email will also include a link to the version.
Faculty Advisor Details	Click the Faculty Advisor Details link to access the Faculty Advisor Details page. The following elements appear: Name Select a faculty advisor name from the prompt table. Faculty Advisor statement Enter a long description.
Study Location	Select a study location code from the list of available values. This option is available only for human protocols.
Adverse Event	Select this option to indicate an adverse event. If it is selected, then the Adverse Event Details link appears. For workflow, by selecting the Adverse Event check box and also submitting the protocol, you will notify the requisite parties about the action. The email will also include a link to the version.
Adverse Event Details	Click to access the Adverse Event Details page. Enter a description of the adverse event.
Assurance Information	Click to access the Assurance Information page, where you can enter an assurance ID, and approval and expiration dates. This option is available only for animal protocols.
Notification History	Click to access the Notification History page, where you can view notification details.