IRB Blueprinting Workshop 1

Transcription

1 Kuali Coeus Implementation: IRB Blueprinting Workshop 1 KC IRB 24: Protocol Development Submission KC IRB 4: 118 Designation October 31, 2013

2 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 gp related to the processes and amend as needed Outcomes Document feedback and action items gathered during the session; distribute to participants for review Utilize the information gathered to further refine business processes, configuration settings, application roles, data assumptions, and gaps 2

3 Presentation Outline Future State Process KC IRB 24: Protocol Development Submission KC IRB 4: 118 Designation Data Assumptions Configuration Values Vl Roles Defined/Assigned Integrations Considerations Potential Gaps 3

4 IRB Future State Development Process # Process Process # Process KC-IRB 1 HRPP Staff Initial Review Process KC-IRB 15 Site Visit 33 preaward future state processes developed KC-IRB 3 IRB Committee KC-IRB 16 Subject Complaints Discussions with MSU T and BC KC-IRB 4 KC-IRB 10 KC-IRB 11 KC-IRB Designation Process Project Closure Process Suspension- Termination Process Renewal-Revision Process KC-IRB 18 KC-IRB 19 KC-IRB 22 KC-IRB 23 Online Review Process Meeting Process High Level IRB Process Post Approval Process KC-IRB 13 Noncompliance KC-IRB 24 Protocol Development- Submission Process KC-IRB 14 UPIRSO KC-IRB 25 Protocol Deviation- Violation Red processes presented today. Green future workshops. Grey processes will not be covered. 4

5 Considerations / Discussion Topics KC IRB IRB24: Protocol Development Submission KC 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 to indicate 118 determination 5

6 KC IRB 24: Protocol Development Submission 6

7 KC IRB 24: Protocol Development Submission (Slide 1 of 4) 7

8 KC IRB 24: Protocol Development Submission (Slide 2 of 4) 8

9 KC IRB 24: Protocol Development Submission (Slide 3 of 4) 9

10 KC IRB 24: Protocol Development Submission (Slide 4 of 4) 10

11 Data Assumptions KC IRB IRB24: Protocol Development Submission Data needed for process initiation Existing protocol (if used as template) Transactional ld data (both input and output) Protocol type* Title* PI* Organizations** Funding sources** Investigators and protocol role Research staff and protocol role 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) *Required field for saving **Only required if selected 11

12 KC IRB 4: 118 Designation 12

13 KC IRB 4: 118 Designation (Slide 1 of 2) 13

14 KC IRB 4: 118 Designation (Slide 2 of 2) 14

15 Data Assumptions KC IRB 4: 118 Designation Data needed for process initiation Existing protocol (if used as template) Transactional data (both input and output) Protocol type* Title* PI* Organizations** Funding sources** Investigators and protocol role Research staff and protocol role Attachments t and notes (as needed) dd) 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 *Required field for saving **Only required dif selected 15

16 Configuration Values Rice Tables KC IRB 24: Protocol Development Submission KC IRB 4: 118 Designation Parameter Values (22, including 3 shared*) Validation Rules (93 out of the box*) Notifications (5) Configuration Items Code Table configuration (69, including 26 shared*) Special Configuration Items Questions and Questionnaires Notification templates * Module wide, not process specific 16

17 Configuration: Code Tables (out of the box values) KC IRB 24: Protocol Development Submission KC IRB 4: 118 Designation Affiliation Type 1. Faculty Non Faculty Affiliate 4. Student Investigator 5. Faculty Supervisor 6. MSU Faculty * 7. MSU Academic Staff ff* 8. MSU Staff * 9. MSU Student * 10. MSU Other * 11. Non MSU Oh Other * Protocol Person Role 1. Correspondent Administrator 2. Co Investigator 3. Correspondent CRC 4. Principal Investigator 5. Study Personnel 6. Secondary Investigator * 7. Additional Investigator t * 8. Research Staff * 9. Study Coordinator * * Proposed MSU additions 17

18 Configuration: Code Tables (out of the box values) KC IRB 24: Protocol Development Submission KC IRB 4: 118 Designation Protocol Attachment Type 1. 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. Other 10. Adverse Event 11. Biography 18

19 Roles Defined/Assigned List of predefined roles and permissions (out of box) Protocol Creator (All System Users) Create Protocol Protocol Aggregator Submit Protocol Modify Protocol Modify Protocol Permissions View Protocol Create Amendment Create Renewal Add Notes Modify Any Protocol Delete Protocol Recall Document Protocol Viewer View Protocol Protocol Deleter Delete Protocol 19

20 Roles Defined/Assigned Out of box Derived Roles (based on relationship to document) Active Committee Member View Committee Active Committee Member on Scheduled Date View Schedule Active Committee Member On Protocol View Protocol IRB Unit Correspondent (Permissions determined by aggregator) IRB Organization Correspondent (Permissions determined by aggregator) Category: ProtocolPersonnel Personnel * PI (Aggregator by default) CO I (Viewer by default) Study Personnel (Viewer by default) Correspondent CRC (Viewer by default) Correspondent Administrator (Viewer by default) Category: Protocol Affiliate Type * (Permissions determined by aggregator) Faculty Non Faculty Affiliate Student Investigator Faculty Supervisor * If the proposed code table configuration values are implemented, the above applicable values would reflect those changes. 20

21 Roles Defined/Assigned List of Roles IRB Nested Roles (made up of grouping several roles together) HRPP Staff (IRB Administrators, HRPP Administrative Assistant, Human Research Liaisons) IRB Administrator Modify All Protocols IRB Reviewer Plus Permission: Modify Protocol Permissions IRB Chair IRB Reviewer Protocol Viewer Plus Permission: View Restricted Notes HRPP Management (HRPP Managers, HRPP Director) IRB Administrator Modify All Protocols IRB Reviewer Maintain IRB Questionnaire Plus Permissions: Modify Protocol Permissions, Maintain KRMS Agenda, Blanket Approve Protocol Document, Blanket Approve Committee Document 21

22 Roles Defined/Assigned Consequence: who has access to what htinformation? 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 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 onthe 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 Deleter. 22

23 Integrations KC Modules Conflict of Interest (COI) Preaward Award Other Kuali Foundation Products Kuali Rice MSU EBS Systems SAP EDW, OOI Business Intelligence (BI) Student Information System (SIS) MSU Legacy and Supplemental Systems SABA (IRB Training) Regulatory websites Clinical Research Management System (CRMS) 23

24 Considerations / Discussion Topics KC IRB IRB24: Protocol Development Submission KC 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 to indicate 118 determination 24

25 IRB Potential Gap List: KC IRB 24 (Slide 1 of 2) Training KC does not provide a way to check training for all individuals id listed on protocol and display whether hth training is necessary. KC does not contain a data field called "Training completed by all PI's" that populates from training data. KC does not identify by name investigators whose training is not up to date. Special Review Amendment KC does not allow for the PI, reviewer, or HRPP staff tffto see the original ii protocol linformation while reviewing an amendment as it treats the amendment as a "new doc. 118 Designation KC system does not have the ability to apply 118 designation determination to a researchproject (protocol/submission status) in such a way that correspondence can be generated and the protocol can be kept by the PI for future submission. Attachments KC does not provide an action script that auto populates p an to an assigned person in the EHS that provides a link to questionnaire answers and no other data in the protocol. KC: PI CV must be uploaded for or in each protocol; FileMaker CV part of system (PI database) (not protocol dependent).

26 IRB Potential Gap List: KC IRB 24 (Slide 2 of 2) Miscellaneous Data Field KC does not provide instruction materials for PI and web application tips prior to the PI beginning application. KC: multiple actions are often required or necessary to produce what can be accomplished in one action in FileMaker. KC does not provide a signature page specific to review level (exempt vs. expedited and full board). Questionnaire KC does not have a PIdatabase database. PI database: unable to enter PI contact information (adding a new record system specific and not protocol specific). KC inability to create a record (unique identifier) in the PI database that allows an individual to be listed on the application as an investigator or study personnel (Guest ID). 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., include compensation in consent).

27 IRB Potential Gap List: KC IRB 4 (Slide 1 of 9) Correspondence KC does not allow for free text to be entered by HRPP staff tffinto correspondences. KC does not allow for additional correspondences without a signature and signature is pre populated and cannot be customized. 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. KC does not allow for QC and regeneration of system generated correspondence in the event of an error. FileMaker: HRPP staff can select which template or correspondence to use for a specific action; in KC, a single template or correspondence is associated with a specific action. KC does not generate any correspondence based on a 118 determination. Correspondence cannot be modified on a "case by case" basis. 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 not allow signatures to be changed (or chosen) on a case by case basis. KC does not allow HRPP staff to select correspondence with or without a signature (FileMaker provides greater flexibility in the use of watermarks). In FileMaker, correspondence is associated with a transaction type; KC correspondence is associated with a specific protocol action.

28 IRB Potential Gap List: KC IRB 4 (Slide 2 of 9) Correspondence KC does not allow correspondences to be added, deleted, dor modified d without t 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 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). Case Manager Assignment 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 reports on case manager workloads. Notifications Notifications cannot be modified on a case by case basis. Agenda KC agenda explanations are not associated with protocols listed in meeting details section and notes regarding agenda explanations are not stored in protocols. KC does not have the functionality to show dates that a transaction was placed "in agenda including "closed", "expedited", business process requires eachtransaction being associated with an agenda date.

29 IRB Potential Gap List: KC IRB 4 (Slide 3 of 9) KC does not contain a data field for the PI's PID number nor a way to search protocols based on PID number and display hyperlinks to the applications. KC does not have a Status tab (Status check: simple 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). KC does not allow for customized searches for any field (or combination of fields) on any application (initial, renewal, amendment, etc). Search Capabilities/Reporting KC does not allow for consolidation of comments for a particular IRB number lookup. KC does not allow for customized searches that will provide hyperlink to the PI form (contact information). KC does not have a Status tab. KC does not allow for customized searches that will FileMaker allows HRPP staff to easily search for and provide hyperlink to reviewer form (contact track all 118 projects. information). 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 FileMaker. individual comments.

30 IRB Potential Gap List: KC IRB 4 (Slide 4 of 9) Search Capabilities/Reporting FileMaker: within each PI record, HRPP staff is able to see all protocols the PIis 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. 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 women or fetuses, neonates, prisoner, children, wards, diminished capacity, HIPAA, FDA regulated, investigational devices (SR/NSR), sponsorinvestigator, 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. PI database: unable to search for and report on all records all records within the database (hyperlinks). PI database: inability to store and link attachments (hyperlinks). Ability to perform multiple searches simultaneously with ability to access full protocol records.

31 IRB Potential Gap List: KC IRB 4 (Slide 5 of 9) Online Review KC does not allow the entry or display of review comment responses by the PI inline with where the comments are entered by HRPP staff. PI must respond to comments as a note or attachment. KC does not retain the individual reviewer determination 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 and comments are determined only by HRPP staff action. KC does not permanently retain (e.g., Summary & History) HRPP staff instructions/comments i submitted to each reviewer (reviewer assignment). KC does not allow HRPP staff to remove a reviewer from the protocol review, but still maintain a record of the review assignment (e.g., if the reviewer was unable to complete review on time). Online Review KC HRPP staff cannot view reviewer comments until they are "submitted" by reviewer due to the transactional nature of the system (comment database, Review tab). Watermarks KC does not allow for multiple watermarks to be on a single document. KC does not allow for watermarks to be applied selectively l to some documents and not to others. KC does not allow different watermarks to be used.

32 IRB Potential Gap List: KC IRB 4 (Slide 6 of 9) Data Field KC does not capture and retain in history the date a reviewer was assigned dto a protocol or data field for "follow up required. KC does not allow the HRPP staff the ability to select tthe status tt options for a protocol; KC status tt is programmed to an action. KC does not allow the business office the ability to determine the status options for a protocol (ability to identify status types related to business needs). Shortcut Keys Reviewer Comments KC does not allow for the ability to print off review 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 all of the review comments in a consolidated d view within the display of "review comments" for each protocol. KC does not retain the original comment left by a reviewer separately if it is edited by HRPP staff. Shortcut keys are not available in KC as they are in Shortcut keys are not available in KC as they are in FileMaker.

33 IRB Potential Gap List: KC IRB 4 (Slide 7 of 9) KC does not allow a user (HRPP staff, PI, or reviewer) )to view attachments t associated itdwith each transaction (initial app, amendment, renewal, etc). User is not able to easily discern which attachments are uploaded for each transaction. KC does not allow HRPP staff to upload 'other' approval documents (documents other than approval letter, etc) (during the approval process). 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 a labor intensive process to ensure correct documents were attached or uploaded by PI (QC review). Attachments FileMaker attachments are associated by 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. 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'). 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 to the attachment). KC no separate attachment location/no ability to KC does not allow HRPP staff to upload ddocuments upload review attachments at any point in the in the protocol or upload attachments at any time protocol lifecycle (no Admin Attachments tab). regardless of the status of the protocol.

34 IRB Potential Gap List: KC IRB 4 (Slide 8 of 9) Identifiers 118 Designation KC does not allow HRPP staff to assign a custom KC system does not have the ability to apply 118 unique identifier for the initial iti application. designation determination to a researchproject (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 does not allow for HRPP staff to free form enter KC does not allow the HRPP staff to include or the current location of the physical file (e.g., associate an Expiration Date with the 118 project. specific HRPP staff member's office). The 118 designation process does not generate an expiration field because the expiration date is not displayed d since it is not a formal approval process. History History KC does not allow HRPP staff to see or print history 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 details is required). KC does not provide the ability to see all 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, HRPP staff and reviewers may see unedited comments; however, PIs are not able to view comments until the record is marked as viewable.

35 IRB Potential Gap List: KC IRB 4 (Slide 9 of 9) Miscellaneous KC does not allow for real time interaction bt between reviewers, PI, and HRPP staff tffdue to its transactional nature. FileMaker ('running banner'): information is easily tracked and displayed to HRPP staff for each record 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 Approval, Most Recent Action that display is not available in KC. KC: multiple actions are often required or necessary to produce what can be accomplished in one action in FileMaker. In FileMaker, a PI is not able to modify the initial application, renewal, or revision application once it 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).

36 Glossary 118 Designation 45 CFR applies to applications to federal agencies that may involve human subjects but where definite research 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 Setting its componentswill interact t 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 integratedproducts 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 36