Clinical Trial Application - College of Physicians and ... · Clinical trial protocol, including inclusion criteria and protocol synopsis Investigator's brochure and/or product monograph,

College of Physicians and Surgeons of British Columbia300–669 Howe Street Vancouver BC V6C 0B4 www.cpsbc.ca

Telephone: 604-733-7758 Toll Free: 1-800-461-3008 (in BC) Fax: 604-733-3503

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NON-HOSPITAL MEDICAL AND SURGICAL FACILITIES ACCREDITATION PROGRAM

Clinical Trial ApplicationFACILITY INFORMATION

Facility name:

NHID: Submission date:

CLINICAL TRIAL INFORMATION

Clinical trial protocol title:

Principal investigator:

Sub-investigator:

Procedure(s)/surgery associated with the conduct of the clinical trial:

Specialized equipment required:

Specialized training required:

Estimated number of patients participating at the non-hospital facility:

Length of time of the study:

Anesthetic level: General – I Local and IV sedation – II Local or topical – III N/A

The following documents are attached:Clinical trial protocol, including inclusion criteria and protocol synopsis

Investigator's brochure and/or product monograph, as appropriate

Independent ethics committee/institutional review board (IEC/IRB) approval letter

IEC/IRB-approved informed consent form

Health Canada letter of no objection (drugs, devices, natural health products)

Study sponsor letter confirming that Health Canada approval is not required

Health Canada Qualified Investigator Undertaking Form

Health Canada Clinical Trial Site Information Form

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College of Physicians and Surgeons of British ColumbiaClinical Trial Application

BYLAWS

The approval of procedures offered at non-hospital medical/surgical facilities is governed by the Bylaws made under the Health Professions Act and in particular section 5-17(2).

5-17 (2) Clinical trials may be conducted at a facility if (a) the investigative procedure is conducted under a properly constituted clinical trial with ethical

oversight, (b) there is no opportunity for the clinical trial to be conducted in an accredited hospital, and (c) the committee has approved the procedure to be performed in the facility under the clinical trial.

Medical director signature: Date:

MEDICAL DIRECTOR APPROVAL AND RECOMMENDATION FOR APPOINTMENT

In signing this document:

• I acknowledge I have reviewed the application and supporting documentation and certify that the information provided in this application is true

• I declare that eligible study participants, as outlined in the clinical trial protocol inclusion criteria, are appropriate for the non-hospital setting

• I declare that the clinical trial protocol study procedures are appropriate for the non-hospital setting

• I declare that there is no opportunity for this clinical trial to be conducted in an accredited hospital

• I confirm that the principal investigator and sub-investigator(s) have privileges at this facility to perform the procedure(s)/surgery associated with the conduct of this clinical trial

I hereby:

Recommend that the principal investigator and sub-investigator(s) be granted all privileges as requested

Recommend that the principal investigator and sub-investigator(s) be granted privileges with the following conditions/modifications

Do no recommend that the principal investigator and sub-investigator(s) be granted privileges

Privilege condition/modification/explanation Notes

Medical director signature: Date:

APPLICATION FEE

A fee of C$150 must accompany the application. C$150 fee is included.

The information in this form is collected under the authority of part 5, section A of the Bylaws under the Health Professions Act, RSBC 1996, c.183. The information provided will be used to process your clinical trial application. If you have any questions about the collection and use of this information, please contact the College at 300–669 Howe Street, Vancouver, BC, V6C 0B4 or by phone at 604-733-7758 or 1-800-461-3008 (toll free in BC).

COLLEGE USE ONLY

NHID:

Date received:

Decision communicated to facility:

Denied

Partial approval

Full approval