Site Feasibility Questionnaire

Instructions: A completed Site Feasibility Questionnaire (SFQ) is required for any external site that will participate in a DF/HCC PI-Initiated Multi-Center Trial. The SFQ must be completed and signed by the external site Principal Investigator and returned, along with any supplemental attachments, to the DF/HCC sponsor.

Protocol Title
DF/HCC Sponsor
Dana-Farber Cancer Institute (DFCI) IRB Protocol Number (if available)
Participating Institution
Participating Institution Address

PART I: External Site Requirements

External sites must review and agree to meet the requirements below. Please initial the boxes below confirming your site’s ability to comply with each of these requirements.

1.  For all interventional trials, the site principal investigator must complete and sign a Form FDA 1572 and submit it to the Coordinating Center prior to initiating any research activities. (N/A for non-interventional trials)


2.  For all interventional drug, biologic, or device trials, only attending physicians may obtain informed consent and re-consent. (N/A for non-interventional trials)

3.  Participants must be registered with the Coordinating Center before the protocol treatment/intervention begins, not including screening eligibility, unless otherwise specified in the protocol.

4.  All adverse events must be reported to the Coordinating Center according to the protocol requirements.

5.  Deviation requests and protocol violations must be submitted to the Coordinating Center per DF/HCC and DFCI IRB requirements, and according to the protocol.

6.  The site principal investigator must allow for the inspection and monitoring of research records and research activities by DF/HCC representatives. This may include providing access to records for onsite or remote monitoring and auditing activities, as defined in the protocol and Data Safety Monitoring Plan.

7.  The site principal investigator must prospectively notify the DF/HCC Sponsor and Coordinating Center of all regulatory inspections that involve a DF/HCC protocol. In addition, the site principal investigator must provide the DF/HCC Sponsor and Coordinating Center with a copy of inspection reports and corrective action plans, if issued.

Note: The DF/HCC Multi-Center Coordinating Committee reserves the right to review and close an external site based on performance, including audit findings, accrual rate and/or data compliance

PART II: Institutional Policies and Attachments

Please attach hard copies or provide links to the institutional policies below:

1.  Institutional Review Board: IRB review and approval processes for each IRB reviewing research at your institution.

Attached Link Provided: No Policy

2.  Biological Samples: Collection, processing and shipment of biological samples, and training of responsible personnel.

Attached Link Provided: No Policy N/A for this protocol

3.  Pharmacy: Dispensing, administration, return, and destruction of investigational agents covering all locations where drug will be stored and administered.

Attached Link Provided: No Policy N/A for this protocol

4.  Monitoring Visits: Policies relevant to monitors and monitoring visits, and any required forms or agreements that monitors must complete in order to gain access to research records at your institution.

Attached Link Provided: No Policy

If “No Policy” was checked for any of the above, please provide a detailed explanation here:

PART II: Contact Information and Research Experience

5.  Please complete the following information for the Principal Investigator for this protocol.

Investigator Name / Years of Research Experience as an Investigator / Number of trials for which currently serving as PI / Total number of trials for which Investigator has served as PI /

6.  Has this investigator ever been audited by the FDA? Yes No

If yes, please indicate whether a 483 was issued. Yes No

7.  Please list key personnel who will be involved in this trial. Attach a separate sheet if necessary.

Role / Name / Title / Phone / Fax / Email / Address /
Regulatory/Research Coordinator / -- / -- /
Research Nurse / -- / -- /
Research Manager / -- / -- /
Legal/Contracts/Budget Contact / -- / -- /
Other / -- / -- /


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PART III: Subject Enrollment

8.  Please provide information on open trials and subject enrollment for the cohort(s) covered by this trial.

Cohort / Expected accrual per month / Are there any competing trials currently open at your institution? /
/ Yes No /
/ Yes No /

PART IV: Facility

Participation in this trial is subject to your institution’s ability to comply with the following protocol-specific facility requirements (*to be completed by the Coordinating Center as necessary):

Procedure* / Specific facility requirement* / Confirmation that site is capable of complying (to be completed by the external site) /
/ Yes No /
/ Yes No /

PART V: Contracts

9.  Does your institution require indemnification and subject injury coverage in order to participate in an academic Investigator-Sponsored clinical trial? Yes No

10.  Does your institution require a fully executed contract and/or finalized budget before the initial IRB submission of the protocol? Yes No

Please note: We cannot offer indemnification or subject injury compensation provisions for DF/HCC trials. If your institution has an internal process for granting a waiver, please describe it here.

PART VI: Satellite Sites

11.  Please list any satellite locations, including their physical address and FWA number, that will participate in research for this protocol.

Satellite locations do not typically require a separate approval. However, a location is considered a separate and distinct site by the DF/HCC if it meets ANY of the following criteria:

·  Requires separate drug shipment;

·  Requires monitoring at a separate location;

·  Requires a separate contract; or

·  Has different budgetary needs (e.g. additional startup fees)

·  Has a separate IRB than the main institution

If any of the above apply, you must submit a separate Site Feasibility Questionnaire for each location.

Investigator Declaration

This form must be completed and returned to the DF/HCC Sponsor before the site can be considered for participation in the clinical trial.

Name of Person Completing Form:

Title/Role at the Site:

**I certify that the information in this form is accurate to the best of my knowledge and that I take full responsibility for it as the Principal Investigator at this site.

Principal Investigator Signature: ______

Printed Name:

Date: ______

This section is for DF/HCC use only

DF/HCC Sponsor Evaluation

Prior to any research activity commencing at the site, the DF/HCC Sponsor must review the information provided by the external site to determine whether or not they are appropriately resourced and capable of performing the clinical trial.

I am satisfied as to the suitability of the Investigator(s) and supporting staff to undertake clinical research at this site. Yes No

I am satisfied that the facilities at this site are of sufficient quality and adequacy to conduct clinical research. Yes No

Site selected for clinical trial participation? Yes No

Signature: ______

Title/Role:

Printed Name:

Date: ______

Version: October, 2016 Page 4 of 5