IRB Blueppgrinting Workshop 1 · 30/10/2013 · Questionnaire KC does not provide a summary list...

Kuali Coeus Implementation:Kuali Coeus Implementation:IRB Blueprinting Workshop 1p g p

KC‐IRB 24: Protocol Development‐SubmissionpKC‐IRB 4: 118 Designation

October 31, 2013

Goals and Outcomes

• Goals

– Obtain feedback on the proposed future state (e.g., to‐be) business processes

– Review the configuration settings and application roles which support the processes within KC

– Review the data assumptions which have been made while drafting the future state business processes

– Review identified gaps related to the processes and amend as neededg p p

• Outcomes

– Document feedback and action items gathered during the session; distribute to participants for reviewdistribute to participants for review

– Utilize the information gathered to further refine business processes, configuration settings, application roles, data assumptions, and gaps

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Presentation Outline

• Future State ProcessKC‐IRB 24: Protocol Development‐SubmissionKC‐IRB 4: 118 Designation

• Data Assumptions C fi ti V l• Configuration Values

• Roles Defined/Assigned • IntegrationsIntegrations • Considerations• Potential Gaps

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IRB Future State DevelopmentProcess # Process Process # Process

• 33 preaward future state processes developed

Process # Process Process # Process

KC-IRB 1 HRPP Staff Initial Review Process

KC-IRB 15 Site Visit

KC-IRB 3 IRB Committee KC-IRB 16 Subject Complaints33 preaward future state processes developed

• Discussions with MSU‐T and BCKC IRB 3 IRB Committee KC IRB 16 Subject Complaints

KC-IRB 4 118 Designation Process

KC-IRB 18 Online Review Process

KC-IRB 10 Project Closure Process

KC-IRB 19 Meeting Process

KC-IRB 11 Suspension-T i ti P

KC-IRB 22 High Level IRB ProcessTermination Process

KC-IRB 12 Renewal-Revision Process

KC-IRB 23 Post Approval Process

KC IRB 13 N li KC IRB 24 P t l D l tKC-IRB 13 Noncompliance KC-IRB 24 Protocol Development-Submission Process

KC-IRB 14 UPIRSO KC-IRB 25 Protocol Deviation-ViolationViolation

Red ‐ processes presented today. Green ‐ future workshops. Grey – processes will not be covered.

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Considerations / Discussion TopicsKC IRB 24: Protocol Development SubmissionKC‐IRB 24: Protocol Development‐SubmissionKC‐IRB 4: 118 Designation

• Roles and permissions

• Uploading of attachments

• Signature page/certification/routing

• Notifications (submission)( )

• Use of submission status

• No system‐generated protocol/submission status toNo system generated protocol/submission status to indicate 118 determination

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KC‐IRB 24: Protocol Development‐SubmissionKC IRB 24: Protocol Development Submission

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KC‐IRB 24: Protocol Development‐Submission(Slide 1 of 4)(Slide 1 of 4)

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Data AssumptionsKC IRB 24: Protocol Development SubmissionKC‐IRB 24: Protocol Development‐Submission • Data needed for process initiation

– Existing protocol (if used as template)i l d (b h i d )• Transactional data (both input and output)

– Protocol type*– Title*– PI*PI– Organizations**– Funding sources**– Investigators and protocol role

h ff d l l– Research staff and protocol role– Attachments and notes (as needed)– Responses to questions in Questionnaire(s)

• Data generated on process completionData generated on process completion– Completed protocol for review– Notifications to administrative offices (if applicable)

*Required field for saving **Only required if selected*Required field for saving **Only required if selected

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KC‐IRB 4: 118 DesignationKC‐IRB 4: 118 Designation

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KC‐IRB 4: 118 Designation(Slide 1 of 2)(Slide 1 of 2)

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KC‐IRB 4: 118 Designation(Slide 2 of 2)(Slide 2 of 2)

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Data AssumptionsKC IRB 4: 118 DesignationKC‐IRB 4: 118 Designation • Data needed for process initiation

– Existing protocol (if used as template)• Transactional data (both input and output)• Transactional data (both input and output)

– Protocol type*– Title*– PI*

Organizations**– Organizations**– Funding sources**– Investigators and protocol role– Research staff and protocol role

Att h t d t ( d d)– Attachments and notes (as needed)– Responses to questions in Questionnaire(s)

• Data generated on process completion– Completed protocol for review– Notifications to administrative offices (if applicable)– 118 determination correspondence– Review attachments

*R i d fi ld f i **O l i d if l t d*Required field for saving **Only required if selected

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Configuration Values – Rice Tablesl l bKC‐IRB 24: Protocol Development‐Submission

KC‐IRB 4: 118 Designation

• Parameter Values (22 i l di 3 h d*)• Parameter Values (22, including 3 shared*)

• Validation Rules (93 out of the box*)

• Notifications (5)• Notifications (5)

• Configuration Items– Code Table configuration (69 including 26 shared*)Code Table configuration (69, including 26 shared )

• Special Configuration Items– Questions and Questionnaires

– Notification templates

* Module‐wide, not process‐specific

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Configuration: Code Tables(out‐of‐the‐box values)( )KC‐IRB 24: Protocol Development‐SubmissionKC‐IRB 4: 118 Designation

Affiliation Type1. Faculty2. Non‐Faculty

ffili

Protocol Person Role1. Correspondent Administrator2. Co‐Investigator3 C d t CRC3. Affiliate

4. Student Investigator5. Faculty Supervisor6. MSU Faculty *7 MSU A d i S ff *

3. Correspondent – CRC4. Principal Investigator5. Study Personnel6. Secondary Investigator *7 Additi l I ti t *7. MSU Academic Staff *

8. MSU Staff *9. MSU Student *10. MSU Other *11 N MSU O h *

7. Additional Investigator *8. Research Staff *9. Study Coordinator *

11. Non MSU Other *

* Proposed MSU additions

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Configuration: Code Tables(out‐of‐the‐box values)( )KC‐IRB 24: Protocol Development‐SubmissionKC‐IRB 4: 118 Designation

Protocol Attachment Type1. Informed Consent Document

2. Recruitment Brochure

3. Advertisement

4. Protocol Narrative

5. Investigator Brochure

6. Children’s Assent Form

7. HIPAA Research Authorization Form

8. HIPAA Waiver of Research Authorization Form

9 Other9. Other

10. Adverse Event

11. Biography

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Roles Defined/Assigned

• List of predefined roles and permissions (out‐of‐box)

Protocol Creator (All System Users)Protocol Creator (All System Users)Create Protocol

Protocol Aggregatorb l

Protocol ViewerSubmit ProtocolModify ProtocolModify Protocol PermissionsView Protocol

View Protocol

Protocol DeleterCreate AmendmentCreate RenewalAdd NotesModify Any Protocol

Protocol DeleterDelete Protocol

Modify Any ProtocolDelete ProtocolRecall Document

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Roles Defined/Assigned Out‐of‐box Derived Roles (based on relationship to document)

Category: Protocol Personnel *

Active Committee MemberView CommitteeActive Committee Member on Scheduled DateView Schedule

Category: Protocol Personnel • PI (Aggregator by default)• CO‐I (Viewer by default)• Study Personnel (Viewer by default)• Correspondent CRC (Viewer by default)View Schedule

Active Committee Member On ProtocolView Protocol

IRB Unit Correspondent

Correspondent CRC (Viewer by default)• Correspondent Administrator (Viewer by default)

Category: Protocol Affiliate Type *(Permissions determined by aggregator)IRB Unit Correspondent

(Permissions determined by aggregator)

IRB Organization Correspondent(Permissions determined by aggregator)

(Permissions determined by aggregator)• Faculty• Non‐Faculty• Affiliate• Student Investigator(Permissions determined by aggregator) Student Investigator• Faculty Supervisor

* If the proposed code table configuration values are implemented, the above applicable valueswould reflect those changes

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would reflect those changes.

Roles Defined/AssignedLi f R l• List of Roles

HRPP Staff IRB Chair

IRB Nested Roles (made up of grouping several roles together)

HRPP Staff (IRB Administrators, HRPP Administrative Assistant, Human Research Liaisons)IRB AdministratorModify All Protocols

IRB ChairIRB ReviewerProtocol ViewerPlus Permission: View Restricted Notes

Modify All ProtocolsIRB ReviewerPlus Permission: Modify Protocol Permissions

HRPP ManagementHRPP Management (HRPP Managers, HRPP Director)IRB AdministratorModify All ProtocolsIRB ReviewerIRB ReviewerMaintain IRB QuestionnairePlus Permissions: Modify Protocol Permissions, Maintain KRMS Agenda, Blanket Approve Protocol Document, Blanket Approve Committee DocumentDocument, Blanket Approve Committee Document

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Roles Defined/AssignedC h h t h t i f ti ?• Consequence: who has access to what information?

– IRB Administrators will have access to all protocols, committee documents, and online review documents to view, modify, delete, recall, and submit the document and attachments as well as take other protocol, committee, and/or online review actions.

– Department and College Administrators will be able to perform the actions associated with the permissions assigned by the Aggregatoractions associated with the permissions assigned by the Aggregator.

– PI will be able to view, modify, delete, recall, and submit the protocol and all related documents as well as take other protocol actions.

– Individuals on the workflow route will receive an FYI notification.Individuals on the workflow route will receive an FYI notification.– Any persons added to the protocol as Aggregator will be able to view, modify, delete, recall, and submit the protocol and all related documents as well as take other protocol actions.

– The person creating the protocol will automatically get the role of Aggregator.

– Other users added to the protocol through the permissions tab, will have either Protocol Viewer Aggregator or Deletereither Protocol Viewer, Aggregator, or Deleter.

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Integrations

• KC Modules– Conflict of Interest (COI)

P d– Preaward– Award

• Other Kuali Foundation ProductsKuali Rice– Kuali Rice

• MSU EBS Systems– SAP‐EDW, OOI– Business Intelligence (BI)Business Intelligence (BI)– Student Information System (SIS)

• MSU Legacy and Supplemental Systems– SABA (IRB Training)SABA (IRB Training)– Regulatory websites– Clinical Research Management System (CRMS)

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Considerations / Discussion TopicsKC IRB 24: Protocol Development SubmissionKC‐IRB 24: Protocol Development‐SubmissionKC‐IRB 4: 118 Designation

• Roles and permissions

• Uploading of attachments

• Signature page/certification/routing

• Notifications (submission)( )

• Use of submission status

• No system‐generated protocol/submission status toNo system generated protocol/submission status to indicate 118 determination

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IRB Potential Gap List: KC‐IRB 24 (Slide 1 of 2)IRB Gaps IRB Gaps p p

Training Amendment

KC does not provide a way to check training for all i di id l li t d t l d di l h th

KC does not allow for the PI, reviewer, or HRPP t ff t th i i l t l i f ti hilindividuals listed on protocol and display whether

training is necessary.staff to see the original protocol information while reviewing an amendment as it treats the amendment as a "new doc“.

KC does not contain a data field called "Training 118 Designationcompleted by all PI's" that populates from training data.

KC does not identify by name investigators whose training is not up to date

KC system does not have the ability to apply ‘118 designation’ determination to a research projecttraining is not up to date. designation determination to a research project (protocol/submission status) in such a way that correspondence can be generated and the protocol can be kept by the PI for future submission.

Special Review AttachmentsSpecial Review Attachments

KC does not provide an action script that auto populates an email to an assigned person in the

KC: PI CV must be uploaded for or in each protocol; FileMaker ‐ CV part of system (PI database) (not p p g p

EHS that provides a link to questionnaire answers and no other data in the protocol.

p y ( ) (protocol dependent).

IRB Potential Gap List: KC‐IRB 24 (Slide 2 of 2)

IRB Gaps IRB Gaps

Miscellaneous Data Field

KC does not provide instruction materials for PI and KC does not have a PI databaseKC does not provide instruction materials for PI and web application tips prior to the PI beginning application.

KC does not have a PI database.

KC: multiple actions are often required or PI database: unable to enter PI contact information necessary to produce what can be accomplished in one action in FileMaker.

(adding a new record ‐ system‐specific and not protocol‐specific).

KC does not provide a signature page specific to review level (exempt vs. expedited and full board).

KC ‐ inability to create a record (unique identifier) in the PI database that allows an individual to bereview level (exempt vs. expedited and full board). in the PI database that allows an individual to be listed on the application as an investigator or study personnel (Guest ID).

Questionnaire

KC does not provide a summary list of questions that need to be completed with hyperlinks to the specific questions

KC does not provide a list of consent form reminders based on answers to the application/questionnaire (e g includespecific questions. application/questionnaire (e.g., include compensation in consent).


Correspondence

KC does not allow for free text to be entered by HRPP t ff i t d

KC does not generate any correspondence based on a 118 determinationHRPP staff into correspondences. a 118 determination.

KC does not allow for additional correspondences without a signature and signature is pre‐populated and cannot be customized.

Correspondence cannot be modified on a "case by case" basis.

KC does not allow for a signature choice on a case by case basis. In KC signatures are automatically populated from the correspondence template identified by the action

FileMaker allows HRPP staff to choose which signature to include on a template in the case where a committee chair may be absent and they need to replace the signature with an alternate. KC does notidentified by the action. replace the signature with an alternate. KC does not allow signatures to be changed (or chosen) on a case by case basis.

KC does not allow for QC and regeneration of system generated correspondence in the event of

KC does not allow HRPP staff to select correspondence with or without a signaturesystem generated correspondence in the event of

an error.correspondence with or without a signature (FileMaker provides greater flexibility in the use of watermarks).

FileMaker: HRPP staff can select which template or d f ifi i i

In FileMaker, correspondence is associated with a i d i i dcorrespondence to use for a specific action; in KC, a

single template or correspondence is associated with a specific action.

transaction type; KC ‐ correspondence is associated with a specific protocol action.


Correspondence Notifications

KC does not allow correspondences to be added, d l t d difi d ith t t di Th

Notifications cannot be modified on a case by case basisdeleted, or modified without custom coding. There

are 28 existing correspondences in HRPP existing processes and only 9 correspondences OOB in KC. All of these will need to be modified and additional

d ill d t b t d

basis.

correspondences will need to be generated.

KC only allows HRPP staff to indicate specific approval language in action comments at time of determination action (not during pending action).

Agenda

Case Manager Assignment KC ‐ agenda explanations are not associated with protocols listed in meeting details section and notes regarding agenda explanations are not stored in protocols.protocols.

KC does not have a data field for case manager which would allow the ability to track changes to case manager by date, to identify the recipient of notices regarding the protocol and to generate

KC does not have the functionality to show dates that a transaction was placed "in agenda” ‐including "closed", "expedited", ‐ business process requires each transaction being associated with annotices regarding the protocol, and to generate

reports on case manager workloads.requires each transaction being associated with an agenda date.


Search Capabilities/Reporting

KC does not contain a data field for the PI's PID b t h t l b d

KC does not allow for consolidation of comments for a particular IRB number lookupnumber nor a way to search protocols based on

PID number and display hyperlinks to the applications.

a particular IRB number lookup.

KC does not have a Status tab (Status check: simple KC does not allow for customized searches that will display ‐ app type, type action, submitted, sent out, approval, letter sent, agenda date, case manager and each "r" or "I" links to the particular transaction; displays easy history).

provide hyperlink to the PI form (contact information).

KC does not allow for customized searches for any field (or combination of fields) on any application (initial, renewal, amendment, etc).

KC does not have a Status tab.

KC d ll f i d h h ill Fil M k ll HRPP ff il h f dKC does not allow for customized searches that will provide hyperlink to reviewer form (contact information).

FileMaker allows HRPP staff to easily search for and track all 118 projects.

KC does not allow for customized searches that will HRPP staff can easily search for and identify PIs in provide hyperlink to a specific record to display individual comments.

y yFileMaker.


Search Capabilities/Reporting

FileMaker: within each PI record, HRPP staff is able t ll t l th PI i i t d ith (

PI database: unable to search for and report on all records all records within the databaseto see all protocols the PI is associated with (e.g.,

assigned as PI, Co‐PI, etc); KC ‐ display not available to the HRPP staff and they must navigate to specific search screens.

records ‐ all records within the database (hyperlinks).

FileMaker ‐ has an "Admin" tab with the following data fields: (comment, approval date with checkbox to select) ‐ alteration of consent, waiver of consent, waiver of documentation, pregnant

PI database: inability to store and link attachments (hyperlinks).

women or fetuses, neonates, prisoner, children, wards, diminished capacity, HIPAA, FDA regulated, investigational devices (SR/NSR), sponsor‐investigator, institutional reliance agreements, individual investigator agreements, noncompliance, audit, federally funded, sites, other (KC ‐ does not have an Admin tab nor a single location that collects all of this data).

PI database: inability to link protocols. Ability to perform multiple searches simultaneously with ability to access full protocol records.


Online Review Online Review

KC does not allow the entry or display of review t b th PI i li ith h

KC ‐ HRPP staff cannot view reviewer comments until they are "submitted" by reviewer due to thecomment responses by the PI inline with where

the comments are entered by HRPP staff. PI must respond to comments as a note or attachment.

until they are submitted by reviewer due to the transactional nature of the system (comment database, Review tab).

KC does not retain the individual reviewer Watermarksdetermination recommendation for approval/disapproval in the online review tab.

KC does not allow for a real time online review and therefore view ability/accessibility of online review

KC does not allow for multiple watermarks to be on a single document.therefore view ability/accessibility of online review

and comments are determined only by HRPP staff action.

a single document.

KC does not permanently retain (e.g., Summary & Hi ) HRPP ff i i /

KC does not allow for watermarks to be applied l i l d d hHistory) HRPP staff instructions/comments

submitted to each reviewer (reviewer assignment).selectively to some documents and not to others.

KC does not allow HRPP staff to remove a reviewer from the protocol review, but still maintain a

KC does not allow different watermarks to be used.p

record of the review assignment (e.g., if the reviewer was unable to complete review on time).


Data Field Reviewer Comments

KC does not capture and retain in history the date a i i d t t l d t fi ld

KC does not allow for the ability to print off review comments left only by HRPP staff (currently allreviewer was assigned to a protocol or data field

for "follow up required“.comments left only by HRPP staff (currently all reviewer and HRPP staff comments would print off at once for current review).

KC does not allow the HRPP staff the ability to l t th t t ti f t l KC t t i

KC does not allow all of the review comments in a lid t d i ithi th di l f " iselect the status options for a protocol; KC status is

programmed to an action.consolidated view within the display of "review comments" for each protocol.

KC does not allow the business office the ability to determine the status options for a protocol (ability

KC does not retain the original comment left by a reviewer separately if it is edited by HRPP staff.

to identify status types related to business needs).

Shortcut Keys

Shortcut keys are not available in KC as they are inShortcut keys are not available in KC as they are in FileMaker.


Attachments

KC does not allow a user (HRPP staff, PI, or i ) t i tt h t i t d ith

FileMaker ‐ attachments are associated by transaction type (I record or r record initial andreviewer) to view attachments associated with

each transaction (initial app, amendment, renewal, etc). User is not able to easily discern which attachments are uploaded for each transaction.

transaction type (I ‐ record or r ‐ record ‐ initial and renewal/revision records); in KC, it is difficult to determine when a document has been revised and with what "R" or "A" record it is associated with.

KC does not allow HRPP staff to upload 'other' approval documents (documents other than approval letter, etc) (during the approval process).

FileMaker provides for the ability to view and print just the approval docs (approval docs ‐ any documents that need to be provided to the PI as part of the 'approval package').

FileMaker: HRPP staff uploads attachments on behalf of PI ‐ process allows the staff to QC documents prior to uploading into the system; KC: PI (and/or HRPP staff) uploads documents ‐may be

KC does not include an administrative tab (currently labeled HRL) where documents can be uploaded and be made viewable to HRPP staff and/or reviewers, but not PIs (includes data elements associated toPI (and/or HRPP staff) uploads documents may be

a labor intensive process to ensure correct documents were attached or uploaded by PI (QC review).

but not PIs (includes data elements associated to the attachment).

KC h l i / bili KC d ll HRPP ff l d dKC ‐ no separate attachment location/no ability to upload review attachments at any point in the protocol lifecycle (no Admin Attachments tab).

KC does not allow HRPP staff to upload documents in the protocol or upload attachments at any time ‐regardless of the status of the protocol.


Identifiers 118 Designation

KC does not allow HRPP staff to assign a custom i id tifi f th i iti l li ti

KC system does not have the ability to apply ‘118 designation’ determination to a research projectunique identifier for the initial application. designation determination to a research project (protocol/submission status) in such a way that correspondence can be generated and the protocol can be kept by the PI for future submission.

KC d t ll f HRPP t ff t f f t KC d t ll th HRPP t ff t i l dKC does not allow for HRPP staff to free form enter the current location of the physical file (e.g., specific HRPP staff member's office).

KC does not allow the HRPP staff to include or associate an Expiration Date with the 118 project. The 118 designation process does not generate an expiration field because the expiration date is not di l d i it i t f l ldisplayed since it is not a formal approval process.

History History

KC does not allow HRPP staff to see or print history KC does not provide the ability to see all of all review comments left over the history of an entire protocol (i.e. protocol summary report only shows most recent review comments) in a consolidated view (previous or next in submission

comments associated with the protocol over its entire lifecycle or the ability to readily find which are associated with initial application and those associated with renewal/revision. In FileMaker,

details is required). HRPP staff and reviewers may see unedited comments; however, PIs are not able to view comments until the record is marked as viewable.


Miscellaneous

KC does not allow for real time interaction b t i PI d HRPP t ff d t it

KC: multiple actions are often required or necessary to produce what can be accomplished in one actionbetween reviewers, PI, and HRPP staff due to its

transactional nature.to produce what can be accomplished in one action in FileMaker.

FileMaker ('running banner'): information is easily tracked and displayed to HRPP staff for each record

In FileMaker, a PI is not able to modify the initial application, renewal, or revision application once it

in the system (initial app, renewal revision, comments, review): Committee, Category, Level of Review, Title of Project, PI, Location, Status, Date Submitted, Record Action, Last Full Review, Current

is submitted to the IRB. In KC, information can be modified upon the ‘Return to PI’ action. Need the ability to track changes within the project (e.g., questionnaire).

Approval, Most Recent Action ‐ that display is not available in KC.

Glossary 118 Designation 45 CFR 46.118 applies to applications to federal agencies that may involve human subjects but where definite

h l ld t ll b t f thresearch plans would not normally be set forth

Code Table Typically provides values for drop‐down lists referenced by the application

COI Conflict of Interest

Configuration The initial arrangement of parameters, code tables, etc. that determines what the application will do and how it t ill i t tSetting its components will interact

CRMS Clinical Research Management System

EHS Environmental Health & Safety

HRPP Human Research Protection Program

IRB Institutional Review Board

KC Kuali Coeus

KFS Kuali Financial System

Kuali Rice Kuali Rice provides middleware suite of integrated productsKuali Rice Kuali Rice, provides middleware suite of integrated products

OOI Organization of Interest

ORA Office of Regulatory Affairs

PI/CO‐I Principal Investigator/Co‐Investigator

SABA Learning Management System to be used in Future State for IRB Training

SAP‐ EDW SAP HR/Payroll Data contained within MSU’s Enterprise Data Warehouse

SIS MSU’s Student Information System

UPIRSO Unanticipated Problems Involving Risks to Subjects or Others

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IRB Blueppgrinting Workshop 1 · 30/10/2013 · Questionnaire KC does not provide a summary list...

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