Office of Research Administration – St. Michael's Hospital

For Internal Use Only

Date Discussion Took Place:
Discussion with:
Office rep initials:

ADDENDUM 1 (CONTRACT ASSESSMENT FORM):

HUMAN SUBJECTS RESEARCH

Complete and return the Contract Assessment Form to your Research Business Analyst to provide appropriate and relevant information pertaining to the study. The information provided will assist in expediting the development, review and/or negotiation of the research agreement.

Section 1: Project Details

Are or will there be any other agencies/companies involved in the study (e.g. Contract Research Organization)?

Yes No

If yes, please describe the involvement.

Are there pre-existing agreements related to the study?Yes No

If yes, please describe the involvement and indicate either a cost centre # or contract ID #.

If you don’t have either number, please provide a copy of the existing agreement.

Cost Centre # Contract ID#

Describe involvement:

Is this a single site study? Yes No

For multi-site studies that are initiated by SMH or where the funding is to be administered by SMH, please see Section 7.

If SMH is a sub-site/sub-grantee/sub-contractor,

Name Lead Institution:

Name Lead PI:

Briefly describe the study intervention (one or two sentences to indicate if a treatment will be provided, blood or DNA samples will be taken, charts will be reviewed, interviews or focus groups will be conducted, etc.).

What is the most important thing that you want to achieve in this agreement?

Please provide any other factors that need to be taken into account in developing or reviewing the agreement (e.g. unique context, precedents/other agreements with source, timing, etc).

Is there any transfer of personal information (e.g. identifiable data, human biological samples etc.)?Yes No

Will confidential (proprietary) information be transferred to or from an external party (e.g., drug information, documents, research methods, or other information that should be kept secret or confidential)? Yes No

If yes, by whom?

What might it be?

Are there any students participating in this study? Yes No

If yes, will it form part of their thesis work? Yes No

(U of T guidelines require reduced publication delays for student thesis work. There may be questions about insurance coverage for non-employee students.)

Do you have adequate space and facilities to undertake this project to completion?Yes No

If “no”, please discuss with your Department Head.

Section 2: Conflict of Interest

Does the SMH Investigator or his/her family member(s) have one or more of the following interests?

Please note that if you select Yes to either of these questions, this information will be used for review under the Research Conflicts of Interest Policy available at ..

No Yes, please contact Marianna Betro at x5521 for details and check all that apply:

Employment, consulting, ownership, or other financial interest in any entity that could benefit from the results of the study (including the funder, sponsor, owner of the study product, or entity that supplies products/materials for the study)

Member of the senior management (e.g. CEO or VP) or an officer or director of any entity that could benefit from the results of the study (including the funder, sponsor, owner of the study product, or entity that supplies products/materials for the study)

Inventorship, copyright or other ownership interest in the study product or a competitor product

Endorsement of the study product or a competitor product (i.e. my name, or my family member’s name, is associated in endorsing the product)

The SMH Investigator is responsible for asking all members of the research team (including co-investigators, research coordinators, research managers, research technicians, administrative staff, etc.) if they have any of the interests listed above.

Are there any disclosures to be made by other members of the research team?

No Yes, please contact Marianna Betro at x5521 for details.

If you answered yes to either of the above, has this information been disclosed in the REB application?

(Please note that we may contact the REB regarding details.)

No Yes

Section 3: Project Certifications

Human Subjects

Are Human Subjects involved in this project at SMH?Yes No

(Includes questionnaires, drugs, blood, tissue, DNA, excreta, tests or other procedures) If yes, complete Section 4 – Study Product.

If Human Subjects are not involved in this project at SMH, are Human Subjects involved at another location?

Yes No

Will this project require a new REB approval?Yes No

If in doubt, please check with the REB Office before you answer this question.

If yes, when will the protocol be submitted to the REB? For which review date?

If no, please provide REB file number:

Biohazards

Are Biohazards involved in this project at SMH? Yes No

Will viral vectors be used/created?Yes No

Radioactive Materials

Does this project involve the use of radioactive materials?Yes No

If yes, please contact the Research Biosafety Committee.

Section 4: Study Product or Equipment (if applicable)

Will a drug, device, biologic or natural health product, etc. be used?Yes No

If yes, name or provide a description of the study product.

Is equipment (not a medical device as described above) being provided by an external entity? Yes No

If yes, name or provide a description of the equipment.

If no to the above two questions, please skip the rest of this Section.

Who is providing the product (for example, the drug, device, biologic or natural health product, etc.) or equipment?

Is the product or equipment coming from another country (i.e., it needs to be imported)? Yes No

If yes, who is listed as the importer?

If a product will be provided by a company, do you want the company to supply the study product free of charge after the end of the study (barring subject safety issues) until it is commercially available in Canada? Yes No

If the study is terminated early, do you want the study product supplied free of charge until the end of the protocol timelines? Yes No

Has a Clinical Trial Application (“CTA”) been submitted to Health Canada for the study products listed above?

Yes No

If yes, please provide a copy of the Health Canada regulatory approval. If no, please explain.

If you require assistance in CTA submission to Health Canada, please contact the Applied Health Research Centre.

Section 5: Contract Terms

Is the publication clause acceptable? Yes No If no, please explain.

Is it acceptable to you that the other party can terminate this study at any time?Yes No

If no, please explain.

Please confirm that you understand you must comply with the confidentiality provisions in the agreement and ensure the rest of your research team also complies. I confirm I request changes to the confidentiality terms

Please contact your Research Business Analyst regarding your requested changes to the confidentiality terms.

If a company is involved, did you approach the company?

I approached the company The company approached me

Section 6: Budget

Have you completed the Clinical Research Study Request Tool? Yes No N/A

If you are using hospital clinical services the Clinical Study Request Tool is mandatory.

The tool can be found at

If Yes, please submit the completed Clinical Research Study Request Tool along with the Service Department Approvals for each clinical service.

Clinical Research Study Request Tool attached

Service Department Approvals (in writing) attached

How many subjects do you intend to enrol or anticipate enrolling?

Is the budget still under negotiation?Yes No

Is the budget acceptable?Yes No

(If you require changes, you must contact your Contract reviewer).

Does the budget cover all the costs of the research? Yes No

If no, how will the other costs be funded?

Budget Details (Attach the detailed budget):

Currency:$CAN $US Other if other, name currency

Period of funding support requested (# of Years):

If the budget is calculated on a per patient basis, fill out the following:

Per patient amount: $

Overhead Rate: %

Is the per patient amount inclusive of overhead? Yes No

If the budget is not calculated on a per patient basis, fill out the following:

Sub-Total Amount of Funding (minus overhead):$

Overhead Rate: %

Total Overhead Amount:$

Total Amount of Funding:$

Note regarding overhead (indirect costs) for non-industry funding: Unless the funding agency has a written policy disallowing overhead (indirect costs), the total costs must include overhead (indirect costs) at the rates allowed by the funding agency (e.g., NIH rate is 8%).

For industry/Investigator initiated clinical research, have you included the following in the budget?

  • REB fee? (If no, we will add it)Yes No
  • Archiving fee?Yes No N/A
  • Audit fee?Yes No N/A
  • Screen failure cost?Yes No N/A
  • Pharmacy fee?Yes No N/A
  • *Non-refundable start-up cost?Yes No N/A
  • Laboratory start-up cost? Yes No N/A
  • Advertising fee? Yes No N/A

If you answered no to any of the above, please select which cost(s) you would like to include and the amount:

(NOTE: Overhead will be added to any amounts listed below):

Archiving fee$1,000 or$

Audit fee$

**Screen failure cost$

Pharmacy Start-up fee (Industry Initiated)$3,000 or$

Pharmacy Start-up fee (Investigator Initiated)$1,500 or$

*Non-refundable start-up $3,000-8,000or$

Laboratory start-up cost (Industry Initiated)$507 or$

Laboratory start-up cost (Investigator Initiated)$207 or$

Advertising fee (specify $5,000-10,000)$

* What do you want the Non-refundable start-up costs to cover (e.g., REB submission preparation time, close-out costs, attending site initiation visit, etc.)?

**Payment schedule for screen failures (points to consider):

1. Are you paid for a fixed number of subjects? Is the “ceiling” reasonable?

2. Are you paid per randomized subject? Is the “ratio” reasonable?

3. Are you paid a flat fee payment vs. a prorated payment based on actual procedures/visits completed? Will the flat fee cover payment of all completed procedures/visits?

Do you want us to add any additional fees to be invoiced in the budget (e.g. annual fees such as the Pharmacy on-call fee, or coordinator time for protocol amendments, etc.)? Yes No

If Yes:

Section 7: Outgoing Agreement (if applicable)

In the event that SMH is the coordinating centre or has initiated this Project:

Is the company/funder aware that other sites will be involved?Yes No

Please list all sites involved in order of priority and provide the contact information for each site (include both external PIs and the contracts or grants officers for each site).

Ext-PI: / Institution: / Contact:
Ext-PI: / Institution: / Contact:
Ext-PI: / Institution: / Contact:
Ext-PI: / Institution: / Contact:
Ext-PI: / Institution: / Contact:
Ext-PI: / Institution: / Contact:

Please attach workscope (roles and responsibilities) for each site.

Please attach a budget breakdown for each site (name currency) and complete sections 6 & 7 only if there is a main agreement with funder.

Revised: September 2009Page 1