M-Inform: Working with COI Administrative Records (CARs)

Overview

COI Staff

CARs are automatically created for PAFs and UFAs that require Conflict of Interest (COI) review; e.g. sponsored by a PHS agency, the PI has answered "yes" to the COI question, or where ORSP has indicated a potential COI. CARs are not automatically created for human subject research applications (HUMs/AMEs) or SUBKs. A CAR must be manually created for these projects, or the projects must be associated with an existing CAR.

CARs are comprised of a single Lead Project and can also include multiple "related projects" (other PAFs, HUMs, AMEs, UFAs, SUBKs, Company Profiles, or other type of projects created by the COI staff such as Master, Innovation Partnerships, SSP, or Procurement that are related to the lead project). Projects can be added or removed from the CAR and the Lead Project can be changed, as needed.

Research Initiated Certifications (RCs), Institutional Conflict of Interest Certifications, and/or Other Support Review Certifications are used to capture the review of a potential individual conflict of interest performed by the COI staff.

Contents

Navigation

COI Staff Dashboard > My Inbox | or Unassigned tab

Step-by-Step Process

Create CAR

  1. Click Create CAR from the project workspace.
  2. Select the desired COI Office Staff Owner.
    Create CAR
  3. (Optional) Enter Comments.
  4. Click OK.

The CAR ID is created and a link to the CAR workspace is added to the record. If the project (PAF, HUM, AME, UFA, SUBK, Company Profile, etc.) is associated with more than one CAR, multiple CAR links will display.

CAR Workspace

CAR workspace

Letter Link/List Description
A Status map Shows the current CAR workflow state and any pending actions
B View/Edit Options to View/ Edit the CAR smartform, Print, and Compare Versions (see what, when, where, and who made changes)
C Activities Actions available to make on the CAR are listed based on the State
D Summary List of COI Office Staff Owners and COI Committee Currently Reviewing, and review dates
E Documents Lists Management Plans for Research Team Personnel, Project, and Additional Documents
F Reviews COI Office information displays Review Summary and includes Administrative Determination, and/or reviews needed
G All Certifications List of all certifications associated with the CAR.
H Lead Project The main project that the CAR is associated with and dates. This can be a PAF, AWD, UFA, SUBK, HUM, AME, Company Profile, or other type of project created by the COI staff, such as Master, Innovation Partnerships, SSP, or Procurement.
I Sponsors List of sponsors associated with the CAR, followed by a Project Summary and Agenda Details.
J Actionable Related Projects List of additional projects "related" to the Lead Project and included in the CAR. These can be PAFs, AWDs, UFAs, SUBKs, HUMs, AMEs, Company Profiles, or other types of projects created by the COI Staff such as Master, Innovation Partnerships, SSP, or Procurement.
K Link to Project Links to the project workspace of each related project. These links open in eRRM, eRPM, or M-Inform.
L Actionable Research Team Personnel An aggregate list of all personnel listed across all projects associated with the CAR (i.e., Lead Project and all related projects)
M COI Office Notes A place for notes entered on activities by the COI Office
N CAR Considerations Lists ICOI, RAR, Has Management Plans, COI OS Review. Yes indicates a “yes” answer. No indicates a “no” answer. With the exception of the Has Management Plans, this view is based on the answers in the CAR smartform.
O eRPM Indicators Lists PHS, COI Indicated on Sponsor Table, Requires OS Review, Students, Human Research of all the related projects on a CAR. This information is based on data from eRPM.

Create Research Certification (RC)

  1. From the CAR workspace, click Create Research Initiated Certification.
  2. Check the Name(s) of the person for whom the RC is being created.
    Create Research Initiated Certification
  3. Click OK.
    Note Links to the created RCs will display next to the Actionable Research Team Personnel on the Summary of the CAR workspace.

Update COI Office Information

  1. From the CAR workspace, click Update COI Office Information under Activities.
  2. Enter or select the COI committee responsible for reviewing.
    Update COI Office Information
  3. Enter or select the COI staff owner.
  4. Enter or select additional COI staff owners.
  5. Enter or lookup to select the COI Committee Currently Reviewing.
  6. Enter COI office notes.
    Note Notes will display on the Summary and Review tabs of the CAR workspace.
  7. Click OK.

Repeat this process to update any of the information at any time.

Assign/Update Staff Owner in RC

  1. Click the name of the RC.
  2. Click Assign COI Staff Owner under Activities.
  3. Click the applicable radio button to select the COI Committee currently reviewing.
    Assign COI Staff Owner
  4. Enter or select the name or uniqname of the COI Staff Owner you want to assign to the project.
  5. (Optional) Enter or select Additional COI Staff Owners.
  6. (Optional) Enter COI Staff Inbox Notes.
  7. Click OK.

Repeat this process to assign a different COI Staff Owner at any time.

Create Institutional Conflict of Interest Certification

  1. From the CAR workspace, click Create Institutional Conflict of Interest Certification.
  2. Enter or select the Company Profile.
    Create Institutional Conflict of Interest Certification
  3. Check the Name(s) of the person for whom the certification is being created.
  4. Click OK.

Create Other Support Certification

  1. From the CAR workspace, click Create Other Support Certification.
    Note This is available in the states of Open, Under Review, or Under Annual Review.
  2. Check the Name(s) of the person for whom the certification is being created.
    Create Other Support Certification
  3. Click OK.

Manage Documents

  1. From the CAR workspace, click Manage Documents.
  2. Click Add to choose a file, or drag and drop files to upload.
    Note After clicking Add, click Show Advanced Options to enter a Description.
    Manage Documents
  3. Click OK.

Post Internal COI Comment

Internal private comments can be posted for COI Office staff only. Comments will display on the Review and History tabs of the CAR workspace.

  1. From the CAR workspace, click Post Internal COI Comment.
  2. Enter comments.
    Post Internal COI Comment
  3. (Optional) Edit the Email Subject Line.
  4. Check the box if you want to include the lead project title and lead project ID in the email notification sent to recipients.
  5. Check the box if you do not want to send an email of your posted comment.
  6. Check the boxes of the names of the COI Office Personnel you wish to notify.
  7. Click OK.

Close CAR

CARs in the state of Open, Review Complete, No Review Required, OS Complete, or No Conflict Found can be closed.

  1. From the CAR workspace, click Close CAR.
  2. Select the reason this CAR is being closed.
    Close CAR
  3. (Optional) Enter Comments.
  4. Click OK.

Complete Initial Review

Reviews can be completed as long as associated RCs are in a Closed or Completed state.

  1. From the CAR workspace, click Complete Initial Review.
  2. Select the Administrative Determination.
    Complete Initial Review
  3. Select the RAR Status from the dropdown list, if applicable.
    Note The RAR questions will only display if the CAR indicates a RAR is needed.
  4. Enter COI office notes.
    Note Notes entered will display on the Summary and Review tabs of the CAR.
  5. Click OK.

On the CAR workspace, the status map will show Complete. The information entered in the activity will display on the Reviews tab of the CAR workspace.

Edit CAR

When a CAR is in the state of Open or Under Review, the CAR can be edited in the smartform.
Note If the CAR is not in an editable state, you can use the Reopen for Edits activity to make it editable, and then the Submit Edits activity to submit any changes.
From here you can edit CAR details.

  1. From the CAR workspace, click Edit CAR.

CAR Details
CAR Details

Change Lead Project

The Lead Project defaults to the project the CAR was created from, and it can be changed if needed.

  1. Click to browse… the Lead Project.
  2. Select the project ID.
    Note Use Filter by to narrow the list of projects to choose from.
  3. Click OK.

Update All Related Projects

  1. Click Update.
  2. Select Yes/No if the project should display in the Actionable section of the CAR.
    Note This answer updates what displays on the Summary of the CAR workspace.
  3. Click OK.

Add Related Project

  1. Click Add.
  2. Enter and select a project to be added, and click OK.
  3. Click OK.
  4. Answer additional questions on the smartform, as applicable. Depending on your answers, additional required questions may display.
    Note Your answers will update what displays on the CAR Considerations box. Answers selected, e.g., RAR Status, ICOI management plan, determine what actions/states display on the Status map.
  5. Enter any COI office notes, if desired.
    Note Notes entered will display on the Summary and Review tabs of the CAR workspace.
  6. Click Continue.

CAR Personnel
CAR Personnel

  1. Click Update next to personnel Name.
  2. Select Yes/No if the person should display in the Actionable Research Team Personnel section, and click OK.
    Note This answer updates what displays on the Summary of the CAR workspace.
  3. Click Finish.
Last Updated: 
Monday, March 28, 2022