OnCore CTMS Access Onboarding/Offboarding/Modification Request

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OnCore CTMS Access Onboarding/Offboarding/Modification Request

This form should be used for:

UW, Fred Hutch, and Legacy SCCA employees to gain access to protocol documents
Study staff supervisors to request access to OnCore for new staff or modify access for existing staff
To request a departed staff member's account to be deactivated

Upon approval of your request by the Access Review Committee (ARC), the staff member will be notified by email of any user attestations and training required for their access level. Once all necessary attestations and training have been completed, the approved permissions will be activated and the user will be notified. (Note that "view-only" access does not require training.)

If you need help completing this form please contact the CTMS Program Office at ctms@fredhutch.org or (206) 667-2868.

REQUEST CANCELED

THIS IS A TEST RECORD

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Internal Notes

Request date

M-D-Y

Purpose of request

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Protocol document access only

New OnCore CTMS user access

Modification to access of an existing user

Offboarding of departing employee

New SRC member

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The "New SRC member" option should only be selected by the
CRS SRC Coordinator.

Staff institution

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Fred Hutch

Seattle Children's Hospital

University of Washington

VA Puget Sound Health Care System

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Where is the staff member benefits eligible?

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Please specify where they are benefits eligible

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Note:

If the staff member will be working on an active billing study in the role of Principal Investigator (PI) or Clinical Research Coordinator (CRC), they will need a SER ID (for PIs) or an EMP ID (for CRCs).

If the staff member has the applicable ID you may enter it when prompted below.

If the staff member does not have the requested ID, please contact the UW IT Help Desk at (206) 543-7012 or mcsos@uw.edu.

Note:

Requested privileges may not be compatible with existing privileges.

Additional privileges are contingent on approval by the CTMS Program Office.

What type of access modification are you requesting?

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Add to existing privileges

Replace existing privileges

Remove existing privileges

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Please describe or list the privileges (e.g., permissions/access) to be removed.

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Please provide justification and/or details about why these permissions are being added to or removed from this user's account.

(Certain permissions are limited among team members to prevent errors and/or delays in the study start up process.)

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Which type(s) of research will the staff member be involved with or need access to documents for?

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Oncology

Fred Hutch Non-Oncology

UW Non-Oncology

Please select the staff member's role

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Study Team

Clinic / Central Lab / Central Resource

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For the studies that the staff member will be working on, which organization(s) is the holder of funds?

Fred Hutch

University of Washington

Seattle Children's Hospital

Other

Which organization(s) is the holder of funds for the studies the staff member will be working on?

Protocol document access user needs Management Group selection

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Staff first name

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Staff middle initial

Staff last name

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Staff title

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Staff phone number

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Staff email address

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STOP!

Please contact the Partner Access Liaison at partneraccess@fredhutch.org to proceed with Fred Hutch on-boarding. Access to OnCore will be requested by the Partner Access Liaison after Fred Hutch credentials have been obtained.

Notice for Seattle Children's Hospital staff:

Fred Hutch or UW credentials (e.g. username@fredhutch.org or username@uw.edu) are required for OnCore Access.

Is this email address also the staff member's UW NetID?

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Yes

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Staff UW NetID

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Does the staff member have UW credentials (e.g. username@uw.edu)?

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Yes

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Please provide the SCH staff member's existing UW username.

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Does the staff member have Fred Hutch credentials (e.g. username@fredhutch.org)?

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Yes

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Please provide the SCH staff member's existing Fred Hutch username.

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Please check here to verify that you have read the instructions and would like to request Fred Hutch credentials for this SCH staff member.

Required for OnCore access

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I agree

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TO BE COMPLETED BY CTMS PROGRAM OFFICE:

The new Fred Hutch account has been created and the credentials have been communicated to the new staff member

Complete

New FH account created for staff member

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Primary Office Location - UW

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FHCC Campus - South Lake Union

UWMC-Montlake - 1959 NE Pacific St

UW Health Sciences Building - 1959 NE Pacific St

UW Tower - 4333 Brooklyn Ave NE

University District Building - 1107 NE 45th St

UW South Lake Union Campus Center

Other

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Please specify the "Other" primary office location

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Primary Office Location - SCH

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SCH Jack R. MacDonald Building - 1900 9th Ave

Seattle Children's Hospital - 4800 Sandpoint Way NE

Ben Towne Center for Childhood Cancer Research - 1100 Olive Way

FHCC Campus - South Lake Union

Other

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Please specify the "Other" primary office location

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Staff physical address

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Staff mail stop

Does the staff member work in a parallel office (CRBB/CTO, CRS, CTMS, Epic, IRO, FHCC CRBO, FHCC CORS/CRT)?

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Yes

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Which office does the staff member work in?

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CRBB/CTO

CRS

CTMS

Epic

IRO

FHCC CRBO

FHCC CORS/CRT

Other

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Note for FHCC CORS/CRT:

This option is for staff members who will not act as study team members (e.g. protocol coordinator, research manager, regulatory, etc.).

If the staff member will act as a study team member, please answer 'No' to the question above ("Does the staff member work in a parallel office?") and then choose the appropriate study team (or "Management Group") when prompted in a subsequent question below.

What is the name of the office?

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Name of a current staff member with permissions to mirror for the new staff member

(Optional)

Please describe, in detail, the activities the staff member will need to perform in OnCore:

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Will the staff member be working on an active billing study in the role of Principal Investigator (PI) or Clinical Research Coordinator (CRC)?

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Yes

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If the staff member will act as a Principal Investigator on an active billing study, please provide their SER ID.

If the staff member will act as a Clinical Research Coordinator on an active billing study, please provide their EMP ID.

Will the staff member need to enter/edit study information in OnCore, or will they only need to view information?

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Enter/Edit

View-Only

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How many studies will the staff member need to enter and/or edit?

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One or two studies only (...)

All studies within selected study team(s) (...)

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How many studies will the staff member need to view?

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One or two studies only (...)

All studies within selected study team(s) (...)

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What scope of studies will the staff member need to view?

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Oncology

Fred Hutch Non-Oncology

UW Non-Oncology

Please enter the protocol number(s) of the studies the staff member will need to access.

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Note:

Please confirm that the staff member really needs this broad scope of access for their work before selecting this option.

Note:

Typically the only groups who would need access to all studies in OnCore are CRBB, Investigational Drug Services (IDS), and PIs/Fellows.

Please confirm that the staff member really needs this scope of access for their work before selecting this option.

Which study team(s) -- or "Management Group(s)" -- will the staff member need to access studies for?

Study teams are referred to as "Management Groups" in OnCore.

The staff member will be granted access to all studies within the Management Group(s) selected here, with the permissions approved for them.

(Select only those necessary.)

Management Group #1

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Request new Management Group

If your Management Group is not listed above please enter its name here. This new Management Group will be added to OnCore pending approval.

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How are the studies conducted by this team categorized?

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Oncology

Fred Hutch Non-Oncology

UW Non-Oncology

Management Group #2

Management Group #3

Additional Management Groups

If the staff member needs access to more than the Management Groups selected above list them here.

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Which study team(s) (or "Management Group(s)") will the staff member need to access studies for?

Study teams are referred to as "Management Groups" in OnCore.

The staff member will be granted access to all studies within the Management Group(s) selected here, with the permissions approved for them.

(Select only those necessary.)

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Auto Immune

Bloodworks NW

Bloom Lab

Breast

Breast Imaging

Burroughs

Cancer Immunotherapy Trials Network (CITN)

Cancer Vaccine Institute

Cardiology CTU

Children's Immunology - Non-oncology

Clinical Research Division (CRD) Morrigan

Clinical Research Division (CRD) Radich

Clinical Scholars

COMPASS

Cord Blood

Elizabeth Loggers - Palliative

Family Functioning Research Program

FH-Admin-Science Education Partnership

FH - Shared Resources

FH COVID CRC

Fred Hutch Pathology

Furlan Lab

Genitourinary Medical Oncology (GUMO)

Genitourinary Medical Oncology Gynecology (GUMO2)

Geraghty Lab

Global Oncology

GVHD

Haffner Lab

HICOR

Hill Lab

Hingorani Pancreas

Holmberg

Human Biology

HVTN

Immunotherapy

Joshua Hill Group

Kiem

Lee Nelson Lab

Mini Transplant

National Clinical Trials Network (NCTN)

Neuro-Oncology

Onc_FH_VIDD_BBE

Paulovich Lab

Petersdorf Lab

Phase 1

PHS Biostatistics

PHS Cancer Prevention

PHS Collaborative Data Services

PHS Computational Biology

PHS Epidemiology

PHS SWOG

PHS Translational Research

Press Lab

Pulmonary

Rad Onc

Renal Group

Sabath Lab

Sangeeta Hingorani

Sarcoma Program

SCCA Community and Network Research Team

SCRI Cancer and Blood Disorder Center (CBDC)

SCRI Gastroenterology

SCRI Immunology

SCRI Infectious Disease

SCRI Palliative Care and Resilience Research Program (PCAR)

School of Public Health, Health Services

Seattle Translational Tumor Research (STTR)

Soheil Meshinchi

Sorror Group

Survivorship

Syrjala

Thoracic Head and Neck (THOR)

Transplant Biology

Transplant Clinical Trials Network (CTN)

UW_COVID_CRC

UW_School of Public Health/Department of Health Services

UW Gastroenterology

UW Gyn (Penington Studies)

UW Hem Div

UW Hem Med Onc

UW Medical Genetics

UW Neurological Surgery

UW Pathology Chen Lab

UW Radiology

UW Radiology - Kinahan

UW Radiology - Nuclear Medicine

UW Radiology - O'Malley

UW SOM - Global Health

UW Urology

VIDD-BBE

VIDD-IDS

VIDD-IVD

Women's Health Initiative (WHI)

Other (...)

Archived Management Group selection:

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Is user from a T3 Pilot study team (Cardiology CTU, Immunotherapy, Phase 1)?

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What information will the staff member need to enter/edit in OnCore?

(Select all that apply.)

Protocols

Enter or update protocol information, maintain protocol staff, complete task lists, enter summary accruals, submit to SRC

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Yes

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IND/IDE (UW Non-Oncology)

Enter and update IND/IDE data in the PC Console > Main > IND/IDE tab (for UW Non Oncology protocols only)

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Yes

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Will the staff member need to open studies to accrual in OnCore?

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Yes

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Note:

By choosing 'Yes' you are acknowledging and approving that this staff member will have open to accrual permission for all studies they have access to.

Subjects

Register subjects, manage subject status lifecycles, enter subject activity dates

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Yes

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Visit Management

Enter subject visits, SAEs, additional procedures, additional visits, subject related financial events, etc; required for protocols with Epic billing

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Yes

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IRB reviews

Record IRB submissions, approvals, and modifications; enter IRB approved document information; upload and release protocol documents; update Other Committee Reviews

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Yes

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Study Startup and Financial Management

Pre Award Management, Post Award Management, Invoicing & Receipts

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Yes

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Which Financials Management actions will the staff member need to perform?

Pre Award Management: Review access to Calendars, Billing Grid, and Budget; sign off on Billing Grids and Budgets
Post Award Management: View-only access to Calendars, Billing Grid, Budget, Subject Visit Tracking, and Invoices; enter subject related financial events
Invoicing & Receipts: View-only access to Calendars, Billing Grid, Budget, and Subject Visit Tracking; enter subject related financial events, generate invoices, and enter receipts

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Pre Award Management

Post Award Management

Invoicing & Receipts

Will the staff member need to access Protected Health Information (PHI)?

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Yes

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Will the staff member need to access protocol documents through document search?

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Yes

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Will the PI need view-only access to study financial information?

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Yes

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SRC member type

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Full Member

Ad-Hoc Member

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Expected first SRC meeting date

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M-D-Y

Expected first SRC review assignment due date

M-D-Y

Advance phone training requested

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Yes

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Date requested for advance phone training

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M-D-Y

Date access is to be revoked

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M-D-Y

Reason for offboarding of staff member:

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Reminder:

Study teams are responsible for ensuring staff lists are up-to-date for all required protocol staff roles. Staff no longer associated with the protocol must have an end date and replacement staff for each role must be entered. For more information on maintaining protocol staff lists in OnCore CTMS, please refer to the Protocol Staff Maintenance Work Instructions (OnCore login required) or email CTMS@fredhutch.org.

Is there a staff member replacing the departing staff member for all assigned protocol staff roles and protocols?

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Yes

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Replacement staff first name

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Replacement staff last name

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Replacement staff title

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Replacement staff email address

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Note:

The CTMS office uses a ticketing system for all communications called Zendesk. To whom should all in-progress emails be assigned when the departing staff member is offboarded?

Zendesk replacement name

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Zendesk replacement email address

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Please enter the email of the person to contact if there are any additional questions.

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Your first name

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Your last name

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Your email address

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Your phone

Time request entry begun

M-D-Y H:M

CTMS assessment/build contact

CSC training contact

CTMS reviewer contact name

CTMS reviewer contact

CRS reviewer contact name

CRS reviewer contact

TRAIN build contact

Training manager contact

SRC Coordinator contact

Project Admin

CRS Customer Support contact

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