Catalogue of Equipment Used in Clinical Trials and Performance Verification Log

Instructions

Below are two templates: 1. Equipment Catalogue for creating a catalogue of equipment that is used during the conduct of a clinical trial, and 2. Performance Verification Log to track performance verification requirements and scheduling.

Add rows to each section as necessary. Include every piece of equipment that may come into contact with a research participant in the stated trial. For example, this includes each blood pressure cuff in each clinic room that may be used.

The equipment catalogue templates below are divided based on whether the equipment is managed either by the hospital, clinical trials group/unit and/or pharmacy. Clearly identify the party responsible for the maintenance of the equipment and corresponding documentation.

For equipment that is managed by the hospital, the Principal Investigator (PI)/Qualified Investigator (QI) should confirm the preventative maintenance and calibration schedule with Biomedical Engineering to ensure it is consistent with the Manufacturer’s recommendation as detailed in the Service Manual.

For equipment managed by the Clinical Trials Group/Unit/ Principal Investigator, complete and maintain a ‘Performance Verification Log’ for each piece of equipment listed in the catalogue.

REB PIN:

Principal Investigator (PI):

Clinical Trial Title:

EQUIPMENT CATALOGUE – HOSPITAL Equipment Description Lo Manufacturer/ Model # Serial # Date Sunnybrook ca Brand Assigned Asset tio (yyyy-mmm-dd) Number n

Version 1 Electrocardiograph M Philips Page Writer US91005150 2010-Oct- 22723 G- TC 70 18 20 2

EQUIPMENT CATALOGUE – PHARMACY Equipment Location Manufacturer/ Model # Serial # Manual Date Assigned Description Brand Location (yyyy-mmm-dd) Sunnybrook Asset Number

Thermometer CG-82 Oakton LoggerPlus N/A Office of 2005-Jan-25 Pharmacy Manager 21469

EQUIPMENT CATALOGUE – CLINICAL TRIALS GROUP/UNIT/PRINCIPAL INVESTIGATOR Equipment Location Manufacturer/ Model # Serial # Manual Date Assigned Description Brand Location (yyyy-mmm-dd) Sunnybrook Asset Number

Centrifuge B7-02 Eppendorf 5702R 0006423 Office of 2007-Mar-05 Clinical Trials Manager 22229

Version 1 Version 1 CLINICAL TRIAL EQUIPMENT – SINGLE DEVICE

PERFORMANCE VERIFICATION LOG

Equipment Location Manufacturer/ Model # Serial # Manual Location Date Performance Description Brand Assig Verification ned Requirements (yyyy- (ie. Annual Calibration) mmm- dd) Sunny brook Asset Numb er Centrifuge B7-02 Eppendorf 5702R 0006423 Office of Clinical Trials 2007- Manager Mar- 05

Date Due Date Completed Service Performed (yyyy-mmm-dd) (yyyy-mmm-dd) (retain evidence of service completed) 2012-Aug-20 2012-Aug-7 Calibration 2013-Aug-7

Version 1