ACTRI Clinical Research Services Request Form

ACTRI Clinical Research Services Request Form
Which service(s) are you requesting? (Please select ALL services required.)

Regulatory Support (IRB Submission) [details]Coordinators & Language Translation (Research Study Support) [details]Use of Clinic (Research Study Visits) [details]Clinical Trials Project Management [details]Pharmacy (Investigational Drug Services) [details]Imaging Services (MRI) [details]Data Safety Monitoring Board (DSMB) [details]Regulatory Affairs (IND/IDE Submission) [details]
In order to request ACTRI translation services, please select 'Coordinators' from the above options and enter your specific translation needs in the Coordinator services field!
CTSS Indicator (utility use only)

CTSS
To request other ACTRI Services, please use this link.

-- Clinic Location Question Section
ACTRI Clinic location(s) requested:*

La Jolla ClinicLinda Vista ClinicBoth LocationsUnsure of Location
If you are unsure about the correct location, please first contact Bernadette Cale (bcale@health.ucsd.edu) and/or Patricia Santana (pmoraes@health.ucsd.edu) to help you determine which location would be the most suitable for your study.

-- -- Linda Vista Section
For Linda Vista Clinic:
Will your study need any UCSD Health Hospital services (Local labs, Pathology, Imaging etc)?

YesNo
Your study will need a Coverage Analysis (CA) and Velos Record/Calendar set-up for billing and scheduling purposes.

For CA, please contact ocaa@ucsd.edu (UCSD Coverage Analysis).

For Velos record, please contact ctri-velos@health.ucsd.edu (https://velos-wiki.ucsd.edu/).

For additional assistance, you can submit a request above for “Clinical Trials Project Management” services and/or email actri-ctss@health.ucsd.edu.
Your study will need a Velos record set-up for scheduling purposes. Please contact ctri-velos@health.ucsd.edu (https://velos-wiki.ucsd.edu/).

For additional assistance, you can submit a request above for “Clinical Trials Project Management” services and/or email actri-ctss@health.ucsd.edu.
Do you currently work with a UCSD-affiliated Clinical Research Coordinator (CRC)?

YesNo
Please ensure that your CRC has Velos and ACTRI Clinic access.
Only a UCSD-affiliated CRC can conduct research at the Linda Vista clinic location. Please also submit a request for “Coordinators & Language Translation” services above for assistance and/or email actri-coordservices@health.ucsd.edu.

-- Reg Support Section
Regulatory Support (IRB Submission)

Please contact actri-ctss@health.ucsd.edu for any questions prior to submitting your request. For more details on Regulatory Support services, click here.
Regulatory Support services offered:*

IRB SubmissionMonitoring/Auditing
Please specify your IRB Submission needs further:*

Investigator-initiated initial submissionSponsor-initiated initial submissionAmendmentAnnual renewalCloseout reportOther

-- Reg Affairs Section
Regulatory Affairs (IND/IDE Submission)

Please contact actri-ctss@health.ucsd.edu for any questions prior to submitting your request. For more details on Regulatory Affairs services, click here.
Is this request for a Drug or Device?*

DrugDevice
Please specify the Name of the Drug/Device:*
Please specify the Indication:*
Please select the Regulatory Affairs service(s) you need:*

ConsultationProtocol DevelopmentIND/IDE/510K SubmissionAnnual Report
RegAff Services (transfer only)

-- Coordinator Section
Coordinators

Please contact Len Lazaro for any questions prior to submitting your request. For more details on Coordinator services, click here.
Please specify the Coordinator service(s) you need:*

-- Clinic Section
Use of Clinic

Please contact ctri-clinic@health.ucsd.edu for any questions prior to submitting your request. For more details on Clinic services, click here.
Please specify the Clinic service(s) you need:*
Does your study require Investigational Drug Services?*

YesNo

-- CTPM Section
Clinical Trials Project Management

Please contact actri-ctss@health.ucsd.edu for any questions prior to submitting your request. For more details on Clinical Trials Project Management services, click here.
Please select the Clinical Trials PM service(s) you need:

Site Qualification ManagementStudy ActivationPost Activation SupportData Management
CTPM Services (transfer only)

-- IDS Section
IDS Pharmacy

Please contact ctri-idspharm@ucsd.edu for any questions prior to submitting your request. For more details on IDS services, click here.
Please specify the Pharmacy service(s) you need:*
Please specify the study location:
ACTRI, JMC, etc.
Please provide the following sponsor contact information:
CRA Name*

FirstLast
CRA Email*
example@example.com
Please upload the Pharmacy Manual here:

Browse Files

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-- MRI Section
Imaging Services (MRI)

Please contact Fang Zhang or Jenna Vuong for any questions (incl. recharge rates) prior to submitting your request. For more details on MRI services, click here.
Please specify the MRI service(s) you need:*
*Please include the following information: (1) Estimated number of scans and approximate project period; (2) Preferred MRI image delivery (e.g., pick up CD at CTIPM, mail CD, send to PACS, don’t send to PACs, etc.); (3) Whether or not a safety read or radiologist assessment is needed (Note: CTIPM doesn’t provide these services, but may help coordinate with radiologist.)
Is site qualification/phantom scan/volunteer scan required?

YesNo
If Yes, please specify:*
*CTIPM does not provide volunteer for site qualification and testing scans. Phantom scans and volunteer scans are subject to regular recharge rates in general.
Please upload the follwing documents:
MRI Protocol

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Coverage Analysis (CA) (required for clinical trials)

Browse Files

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CITI Good Clinical Practice Certification (required for members who have direct patient interaction)

Browse Files
*Please upload all certifications in one combined document! Cancelof

-- DSMB Section
Data Safety Monitoring Board

Please contact Kathryn Gold, MD for any questions prior to submitting your request. For more details on DSMB services, click here.
Please specify the DSMB service(s) you need:*

-- Study Info Section
Study Information
Study Title*
Approximate Study Start Date*
IRB Approval Status*
IRB Approval Letter

Browse Files
*If not yet available, please provide as soon as it becomes available! Cancelof
IRB Number
*If not yet available, please provide as soon as it becomes available!
Please upload the follwing documents (if available):
In order to evaluate your ACTRI voucher eligibility, at least one of the following documents needs to be attached!
Study Outline or Abstract*

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Research Protocol*

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Informed Consent Form*

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Note: Missing documents require follow-up and will delay the process!
PI Information
PI First Name*
PI Last Name*
PI Full Name
PI Email*
example@example.com
PI Department*
Please indicate PI's ACTRI membership level:*

General (existing or pending)Associate (existing or pending)Affiliate (existing or pending)No membership / Don't know
If you are not an ACTRI member yet, please click here to review membership eligibility criteria and submit your application. Once submitted, please select the applicable membership level from the above options to proceed.

-- Contact Person Section
Contact Person Information
Contact Person same as PI?

Yes
Contact Name*

FirstLast
Contact Email*
example@example.com
Contact Department*

-- Voucher Section
ACTRI Voucher Program
As an existing (or pending) ACTRI General or Associate Member, you may qualify for the ACTRI Voucher Program. Please review the ACTRI voucher eligibility criteria and available support levels for details. The below recharge information is required regardless of any subsequent voucher application!
The ACTRI voucher capacity has been reached for this voucher period. You may submit your voucher request after the new voucher period begins on May 1, 2024.
Would you like to participate in the ACTRI Voucher Program (Clinic, Coordinators, and Regulatory Support only)?

Yes
If you have already submitted a separate voucher request, please do not submit another one!
Please specify the intended use of the voucher?*

Support unfunded project designed to gather preliminary data for a grant submission.Supplement NIH-approved funds for clinical services required for the project.ACTRI Pilot Project, Career Development Award (K-series only; UC San Diego only), or ACTRI KL2 AwardOther
Confirmation:*

I confirm that I have read and understood the ACTRI voucher terms.
For any additional voucher-related questions, please contact ctri-fin-recharges@health.ucsd.edu prior to submitting your request!

-- Recharge Section
Recharge Information

Please provide valid fund manager and OFC chartstring information for recharge purposes.

Click here to review current ACTRI recharge rates.
Fund Manager Name*

First NameLast Name
Fund Manager Email*
example@example.com
OFC Project:*
Always required! (7 digit numerical value)
OFC Task:*
Always required! (1-3 digit numerical value)
OFC Funding Source:
Required for sponsored projects only! (5-7 character alphanumerical value)
Award #:
Providing incorrect or incomplete OFC chartstring information will require further clarification and delay the process! Contact your fund manager or use the chartstring verification tool (requires VPN connection) to ensure chartstring accuracy prior to submission.
Is this a backup chartstring?

Yes

ACTRI Backup Chartstring Agreement (click to expand)
ACTRI Backup Chartstring Agreement

General Approach

Backup chartstrings will be treated differently from actual chartstrings during the billing process. Any service recharges associated with a backup chartstring will be held back for the duration of up to one (1) year from the date of the first recharge service provided. During this one-year grace period, the PI has the opportunity and obligation to provide an actual chartstring (once available) to ACTRI Finance. If, after one year, no actual (and valid*) chartstring has been provided by the PI, ACTRI Finance will proceed with charging any outstanding balances from services rendered to the backup chartstring. Any subsequent internal fund transfers will be the responsibility of the fund manager of the PI’s home department.

Backup chartstrings were implemented to accommodate PIs whose studies have not been awarded funds yet due to ongoing contract and/or budget negotiations. However, the obligation to settle any outstanding balances is independent from the successful initiation/execution of a given study/contract. PIs will be charged any outstanding balances from services received either (a) upon provision of an actual chartstring during the one-year grace period or (b) upon expiration of the one-year grace period, using the backup chartstring.

At ACTRI’s sole discretion, the one-year grace period may be extended in case of any additional contracting and/or budgeting delays that are outside of the PI’s control.

Site Qualification Management Exception

All site qualification management services will be automatically recharged six (6) months after service provision, regardless of whether the site was selected or not. Any related IRB submission services will be recharged in accordance with the general approach specified above.

*) ‘Valid’ means the chartstring is active and chargeable, and the service dates would fall within the start and end date of the chartstring of the fund.

For additional details on ACTRI Terms and Conditions for Support, click here.

-- Backup Chartstring Signature
Signature

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Sign here to acknowledge agreement!

-- Integration Utility Section
RC_RegSupport
RC_Coord
RC_Clinic
RC_CTPM
RC_Pharmacy
RC_Imaging
RC_DSMB
RC_RegAffairs
Request Contains SVC (transfer only)
Request Contains VOU (transfer only)
REG Short Name
CTSS Short Name VOU
CTSS Voucher Amount
RA Short Name
CTPM Short Name
CRD Short Name SVC
CRD Short Name VOU
CRD Voucher Amount
CLN Short Name SVC
CLN IDS Flag
CLN Short Name VOU
CLN Voucher Amount
IDS Short Name
MRI Short Name
DSMB Short Name
Service Request Flag (VOU only)
Service Request Ref# (VOU only)
Should be Empty:

ACTRI Clinical Research Services Request Form

Recharge Information