VCHRI Office of Clinical Trials

AdministrationStephania ManushaRegional Manager,

Clinical Trials Administration VCH

Presentation Outline:

• Overview • VCH Operational Approval Process• Clinical Trial Agreements• Finance - Clinical Trial Payments• Questions

Key Responsibilities

• Contracting (limited to industry initiated clinical trials).

• VCH Operational Approvals (i.e., Request for Approval to Conduct Research).

• Finance (receipt and deposit of clinical trial payments).

• Other (e.g., VCH Standard Operating Procedures for Clinical Research; patient recruitment section on VCHRI website; researchpolicies and guidelines; content of CT Communicator).

Website• http://www.vchri.ca/s/Home.asp

– For Faculty and Staff:• Under the Clinical Research Tab, “Forms to Download Section”, you will find

all VCH operational approval research forms and guidelines, including Clinical Trial Synopsis form.

• Forms and Guidelines are updated on an ongoing basis, so it is always best to download forms and guidelines from the web.

– For Patients:• ACTIVE RESEARCH STUDIES: Researchers now have the ability to post

their research studies on the VCHRI website for recruitment purposes.• As this part of the website has only recently been developed, stats are not

yet available (e.g., average # of hits per month).

Key Contacts

• Stephania Manusha, Regional Manager Clinical Trials Administration:– Industry Initiated Clinical Trials– VCH Research Policies, Guidelines or Forms (Operational

Review and Approval)– Other: Such as, Patient Recruitment Website

• Wylo Kayle, Assistant Clinical Trials Administration:– VCH Approvals and Renewals (Vancouver Acute, Multi-Site and

Corporate research projects)– Clinical Trial Payments

VCH Operational Approvals

(Request for Approval To Conduct Research Form)

What is VCH Operational Approval of Research?

• This approval process allows for the review and approval of research projects that impact or affect any VCH resources.

• This includes research projects conducted by VCH researchers and researchers external to VCH.

• There are 2 main components:– Proof of Ethical Approval– VCH Department/Unit Impact Review

What is VCH Operational Approval of Research?

• #1 Proof of Ethical Review:– VCH has an agreement with the University of British

Columbia Ethics Boards to provide ethical review & approval for all research conducted within VCH.

– As part of the Operational Approval process, researchers are required to provide a copy of the Certificate of Approval from the ethics board to VCHRI.

What is VCH Operational Approval of Research?

• #2 VCH Department/Unit Impact Review:– The purpose of this review is to identify which VCH

departments are affected by the research and to determine each department’s ability to support the research.

What is VCH Operational Approval of Research?

• The information for the VCH Operational Approval is collected on the “Request for Approval to Conduct Research” form.

• There are several versions of this form (developed by each HSDA).

• Need to know which version to use…

How to Obtain Operational Approval

• VCH has been separated into 4 areas:– Vancouver Acute: VGH, UBCH, DHCC, GFS, Mary Pack

– Vancouver Community: VCH Community Clinics

– Coastal: includes LGH, North Shore Community Clinics, Coast of Garibaldi.

– Richmond Health Services: Richmond Hospital and Richmond Community Clinics.

How to Obtain Operational Approval

HSDA VCHRI ContactRichmond Health Services Dr. Ingrid Sochting

VCHRI Assistant Director, Richmond Health Services

Vancouver Community Val Munroe VCHRI Assistant Director, Vancouver Community

Coastal Dr. Cynthia Hamilton, VCHRI Assistant Director, Coastal

Vancouver Acute, Multi-Site (HSDA) & Corporate Research Projects

Wylo KayleAssistant, VCHRI Clinical Trials Administration

How to Obtain Operational Approval

• The researcher completes the “Request for Approval to Conduct Research” form.

• Basic information• Signatures of Approval• Series of “Leading” Questions

• For the purpose of this presentation, refer to the Vancouver Acute forms.

How to Obtain Operational Approval

• Page 1:– The form must be signed by the researcher, and co-signed by

his/her Manager, Division Head, and Department Head (as applicable).

How to Obtain Operational Approval

• Page 2: All departments affected by the research should be identified.– Researcher discusses the potential impact of the research study

with the Manager from each department. – When the Manager agrees to support the research, and matters

such as cost recovery and protocol concerns, etc., have been addressed, the Manager signs the form.

• Our office will look for a signature of approval from each department impacted.

Department Review Processes

• Guidelines summarize the requirements of each department. – Review the guidelines.– Department processes vary (i.e., some departments

require review fees).– Some department review processes are complicated.

• Sometimes, departments make changes, and don’t notify our office.

Privacy

• If the research project requires access to personal health information of patients/clients/residents/staff:– “Confidentiality Undertaking for Research Projects” must be

signed.– Each research team member must sign this form.

• Database Access for Research Projects Application Form.– Completed if you are accessing any VCH Clinical Systems (e.g.,

PCIS, ORMIS, systems maintained by Decision Support).

What happens once I submit the VCH Request for Approval Form?

• For Vancouver Acute, Multi-Site and Corporate Research Projects:– Application is received.– Initial review of the application is conducted.– A second review of the application is conducted.– A list of queries is sent to the contact person listed on the

application.– Once all outstanding issues are resolved, a Certificate of

Approval is sent to the investigator and contact person.– Review times: Approximately 3 weeks.

Renewal, Amendments, and Notice of Study Closure

• As with your UBC ethics, you need to apply for annual renewal through VCHRI.– Renewal consists of a one page form.– Helps us to keep our files up to date, and helps

ensure that you have all necessary VCH department approvals required to conduct research.

• Additional resources required part way through the research study?

• Notice of Study Closure – very helpful if you let us know when your study has been completed.

Clinical Trial Agreements

Outline:

• Who negotiates contracts? • When do I contact OCTA? • What is a Clinical Trial Agreement (CTA)?• Why is it important to have a CTA?• How do I work most effectively with OCTA?

Who negotiates contracts

For Industry-Initiated Research, which is conducted by VCH Investigators within Vancouver Coastal Health Authority [Confidentiality Agreements, Clinical Trial Agreements, Amendments to Clinical Trial Agreements, Subcontracts, Master Clinical Trial Agreements].

Stephania Manusha Regional Manager, Clinical Trials AdministrationTel: (604) 875-5649Email: stephania.manusha@vch.ca

For collaborative research agreements, grant-in-aids, service contracts, investigator-initiated clinical research, government and non-profit contracts and agreements, material transfer agreements:

UBC UILO: http://www.uilo.ubc.ca/partnering/types.html

When do I contact OCTA?

• Confidentiality Disclosure Agreements/Non-Disclosure Agreements (CDA/NDA) for Clinical Trials– Agreements to ensure confidentiality of proprietary data that

Sponsor gives to Investigator in order to make a determination as to whether or not he/she will participate in the trial.

– Typically, CDAs are between Sponsor & Investigator only.• In most cases, the OCTA does not see these agreements.• If Investigator would like the CDA/NDA to be reviewed by OCTA

before signing it, we are happy to do so.– Some companies request that the Institution be a party to the

CDA. • In this case, the OCTA must review the agreement before the

Institution will sign.

When do I contact OCTA?As soon as the Sponsor selects you as a site and the

Investigator agrees to participate in the clinical trial.– Submit a Clinical Trial Synopsis Form. This form provides basic

information about the clinical trial.• Sponsor/CRO contact.• Where the account for this study will be held (at VCHA or UBC).• Some additional information about the trial, to assist us in our review of the

agreement.– Upon receipt of this form, a UBC Rise FAS# is assigned and a file is

opened.

What is a Clinical Trial Agreement?

A legally binding agreement that manages the relationship between the Sponsor [Industry] or CRO who may be providing:

– Study Drug or Device– Financial Support– Proprietary Information

And the Institution [VCHA, UBC and Investigator] who may be providing:

– Data and/or Results – Publication, Input into Publication– Input into further Intellectual Property

Why is it important to have a CTA?

• Allocation of– Risk– Responsibility– Money– Obligations

• Protection of– Rights (academic, legal, intellectual property)– Academic Integrity

How long will it take to complete a Clinical Trial Agreement?

• Is there a Master Clinical Trial Agreement?• Do we have a template agreement?• Is the sponsor willing to use the template?• Have we worked with the sponsor before?

– What about other UBC affiliated sites?• Is a CRO involved?• Workload.

How do I work most effectively with OCTA?

• Let us know ASAP– We’re here to assist

• Communication is key– Ask questions– Continue to provide new information you receive

• Help us help you– Synopsis– Important deadlines (REB, Site Institution)….

Clinical Trial Payments

• Payee included in the clinical trial agreement.– VCH or UBC – Determined by Investigator

• Where will most of my expenses be incurred?• Familiarity and personal preference.

• All payments sent c/o VCHRI.– If investigator/research coordinator receives a cheque

from Sponsor, send it to VCHRI. • Payments normally made by cheque.

– Direct Deposit.

When is an account set up?

• Upon receipt of the first cheque. • For VCH:

– Copy of the clinical trial agreement is sent to VCH Finance, along with the first Cheque Deposit Form.

– Notification of opening of account forwarded to investigator upon activation of the account.

• For UBC:– Notification from UBC finance directly to investigator.

VCH Cheque Process

• VCH Cheques:– The cheque and back up documentation is sent by

Sponsor to VCHRI.– Cheque Receipt Fax with a copy of the back up

documentation is sent to the investigator/research coordinator.

– “Cheque Deposit Form” is completed by investigator/research coordinator and forwarded to VCHRI.

– Overhead is calculated by VCHRI.

UBC Cheque Process

• UBC Cheques:– The cheque and back up documentation is sent by

Sponsor to VCHRI.– Cheque is entered into the UBC financial system.– Overhead is deducted by VCHRI.– Deposit confirmation memo is sent by VCHRI to

investigator/research coordinator.

Overhead

• Overhead for clinical trials is 25%.• All clinical trial payments are subject to

overhead, with a few exceptions:– REB review fee;– Advertisements;– Patient travel reimbursement or stipends.

Who do I contact?

• Regarding an error in overhead calculation: – VCHRI (Wylo Kayle)

• Regarding account statements, cheque requisitions, whether a cheque has been issued/bill paid:– Finance…

Other

• Patient Recruitment Section of VCHRI website.

• Clinical Research SOPs.• Clinical Trial Newsletter. • Research Confidentiality and Privacy

Policy.

Thank you for listening!