Office of Clinical Trials Administration (OCTA)/PI-Study Team

Roles and Responsibilities

Interacting with OCTA



PURPOSE: Providing a checklist outline to identify and explain interacting with the Office of Clinical Trials Administration (OCTA) for pre- and post-award activities of commercially-sponsored clinical trials. 

Table of Contents

 

Pre-Award Activities

Type of Activity

PI

Study Team

OCTA Contracts Team

OCTA Budgets/Finance
Team

Chair and
DBO/MSO

Confidential Disclosure Agreement (CDA)/Non-Disclosure Agreement (NDA)

For questions, contact OCTA at octa@ucsd.edu

Receive Sponsor/CRO email with request to sign a CDA/NDA for potential clinical trial

X

 

 

 

 

Submit CDA/NDA for contract review and negotiation through http://som.ucsd.edu/OCTAApplication 

X*

X

 

 

 

OCTA responds to study team questions about CDA/NDA

 

 

X

 

 

Review, negotiate, and facilitate execution of CDA/NDA with Sponsor/CRO

 

 

X

 

 

Respond to requests for information or approval regarding the CDA/NDA

X

X

 

 

 

At request of OCTA, Principal Investigator signs CDA/NDA as “read and understood” (as applicable)

X

 

 

 

 

Sign CDA/NDA on behalf of UCSD and obtain fully executed copy from Sponsor

 

 

X

 

 

Receive and review Study feasibility documents (e.g. Protocol) and correspond with Sponsor regarding PI’s participation in the Study

X

X

 

 

 

Clinical Trial Agreement (CTA)

 

Complete Facesheets and obtain IRB number

 

X

 

 

 

Complete the electronic proposal through the ePD system (ePD Proposal), with the following attachments:

  • Sponsor’s draft contract
  • Sponsor’s draft payment schedule and/or budget grid
  • Internal budget (if department is negotiating the budget)
  • Protocol

 

X

 

 

 

Indicate on the ePD Proposal whether OCTA budget services will be used. If so, attach required documentation: Sponsor’s draft budget, internal budget, Protocol, and Informed Consent Form.

X*

X

 

 

 

Review and approve the ePD Proposal before submission to OCTA. ePD number from COEUS is generated automatically.

X

 

 

 

X

OCTA receives the ePD Proposal and reviews.

 

 

X

 

 

Respond to requests for information or approval regarding the ePD Proposal.

X

X

 

 

 

Per ePD Proposal, a CTA number is generated in COEUS and emailed to the study team

 

 

X

 

 

Submit study documents for Institutional Review Board (IRB) review and correspond with HRPP to achieve IRB approval.

X*

X

 

 

 

Complete and Sign a 700-U form and 700-U Addendum, as applicable. These forms can be obtained from the Conflict of Interest department:  coiforms@ucsd.edu

X

 

 

 

 

Email the completed and signed  700-U form and 700-U Addendum, as applicable, with the EPD number or the COEUS 8 digit number and IRB number written in the upper right hand corner of each form to the Conflict of Interest (COI) Office at coiforms@ucsd.edu only.

X*

X

 

 

 

Work with ancillary departments including, but not limited to, OCAA, Velos (bulk accounts), etc.

X*

X

 

 

 

OCTA responds to study team questions about CTA

 

 

X

 

 

 Review, negotiate, and facilitate execution of the Clinical Trial Agreement (CTA)

 

 

 

X

 

 

Review documents, draft, negotiate, and finalize the Study budget grid and/or payment schedule, as applicable:

 

 

 

 

X

 

X

X

 

 

 

 

Respond to OCTA’s requests for information or approval regarding budget and contract

X

X

 

 

 

Review and confirm approval of contract and budget terms upon request

X

 

 

 

 

At request of OCTA and when OCTA has deemed the contract as finalized, Principal Investigator signs CTA as “read and understood”

X

 

 

 

 

Sign CTA on behalf of the Regents of the University of California and obtain fully executed copy from Sponsor

 

 

X

 

 

Release OCTA hold with HRPP upon contract execution

 

 

X

 

 

Upon receipt of notice of IRB approval, activate and generate an index number. Email index number and contract to Study Team contact and PI

 

 

 

X

 

Clinical Trial Agreement Amendments

 

Submit Sponsor’s draft contract amendment (including amended budget, if applicable) for review and negotiation through OCTA Application

 

X

 

 

 

OCTA responds to study team questions about contract amendment

 

 

X

 

 

Review, negotiate, and facilitate execution of contract amendment with Sponsor/CRO

 

 

X

 

 

Review, draft, negotiate, and finalize the budget amendment to be amended directly with Sponsor/CRO:

  • If using OCTA budget services
  • If department is negotiating budget

 

 

 

 

X

 

X

X

 

 

 

 

Respond to OCTA’s requests for information or approval regarding budget and contract amendment documents, as applicable

X

X

 

 

 

If Amendment references a Protocol amendment, ensure updated Protocol has been submitted to and approved by HRPP

X*

X

 

 

 

If Amendment affects the budget, work with OCAA to amend the Coverage Analysis, as applicable and obtain OCAA approval

X*

X

 

 

 

Review and confirm approval of contract and budget terms in amendment upon request

X

 

 

 

 

At request of OCTA when OCTA has deemed the amendment as finalized, Principal Investigator signs contract amendment as “read and understood”

X

 

 

 

 

Sign Amendment on behalf of the Regents of the University of California and obtain fully executed copy from Sponsor

 

 

X

 

 

 

Post-Award Activities

 

Type of Activity

PI

Study Team

OCTA Contracts Team

OCTA Budgets/Finance
Team

Chair and
DBO/MSO

Invoicing, Checks, and Refunds

For questions, contact OCTAFinancials@ucsd.edu

Perform clinical trial per Protocol(s) and contract terms

X

X

 

 

 

Invoice Sponsor for services performed

 

X

 

 

 

Receive checks from Sponsor

 

 

 

X

 

Determine if OCTA has sufficient information to deposit check in the appropriate study. If unknown, post to the "unclaimed check screan on the OCTA Application"

 

 

 

X

 

Review and assess if IRB renewal fees and OCTA budget fees need to be taken out of Sponsor’s payment

 

 

 

X

 

Process and deposit checks

 

 

 

X

 

Alert the study team that check(s) have been deposit

 

 

 

X

 

Send the study team a copy of the check(s) deposited

 

 

 

X

 

Review ledger and ensure funds are accurately reported

 

X

 

 

 

Monitor expenses and ensure all costs are properly reflected on the index

X*

X

 

 

X (DBO)

Search for and claim unidentified checks via the "unclaimed check screen on the OCTA Application" and email OCTA Finance team with a copy of the invoice

 

X

 

 

 

Search bank wires (via the General Accounting bank wires website) and contact OCTA Finance team

 

X

 

 

 

Email the OCTA Finance team to request information and refund or correction of checks

 

X

 

 

 

Deposit funds daily via OCTA Application

 

 

 

X

 

Health Sciences Controller’s Office posts study revenue to study index on a weekly basis

 

 

 

 

 

Enter corrections or refunds as applicable

 

 

 

X

 

Cost Transfers

 

Draft cost transfer with KLT template in accordance with University policy

 

X

 

 

 

Forward cost transfer request to OCTA Finance team

 

X

 

 

 

Review and approve transfer

 

 

 

X

 

Notify study team of any clarifications needed

 

 

 

X

 

Correct and resubmit cost transfer, if required

 

X

 

 

 

Approve cost transfer

 

 

 

X

 

Study Close-Out

 

Close out indexes by zeroing out and inactivating index

X*

X

 

 

 

Notify OCTA Finance Team of study closure

 

X

 

 

 


Useful Links:

OCTA Website:


OCTA Application:

http://healthsciences.ucsd.edu/vchs/research-services/octa/Pages/default.aspx


http://som.ucsd.edu/OCTAApplication

OCAA:

https://healthsciences.ucsd.edu/vchs/research-services/clinical-research/ocaa/Pages/default.aspx

HRPP:

http://irb.ucsd.edu

Velos:

https://actri.ucsd.edu/Informatics/velos/Pages/default.aspx

ePD:

ePD What You Need to Know

http://epd.ucsd.edu/coeus/userAuthAction.do


http://blink.ucsd.edu/research/preparing-proposals/proposal-development/epd/about.html

COI:

http://blink.ucsd.edu/sponsor/coi/index.html

 

Useful Emails and Phone Numbers:

OCTA (main)

octa@ucsd.edu

(858) 822-2940

OCTA Budget/Finance Team

octafinancials@ucsd.edu

(858) 822-4504

OCAA

ocaa@ucsd.edu

(858) 534-4622

ePD

epdhelp@ucsd.edu

(858) 435-9979

HRPP

hrpp@ucsd.edu

(858) 246-4777

COI

coiforms@ucsd.edu

(858) 534-6465

Velos

ctri-velos@ucsd.edu

(858) 534-0555

 

 

Glossary

 

CDA

Confidential Disclosure Agreement

COI

Conflict of Interest

CRO

Contract Research Organization – an organization that provides support to pharmaceutical companies in administering a clinical study

CTA

Clinical Trial Agreement

DBO

Direct Business Officer

ePD

Electronic Proposal Database

HRPP

Human Research Protections Program

IRB

Institutional Review Board

MSO

Management Services Officer

NDA

Non-Disclosure Agreement

OCAA

Office of Coverage Analysis Administration

OCTA

Office of Clinical Trials Administration

PI

Principal Investigator

Sponsor

A for-profit entity that initiates and takes responsibility for a clinical investigation

Study team

Principal Investigator, co-Investigator(s), Project Manager(s), study coordinator(s), regulatory personnel, and fund manager(s)