CPU SERVICES INITIAL SITE EVALUATION

  1. Basic Information

Unit Name:

Address:

City, State, Zip:

Website:

Contact Name:

Telephone:

Email:

Pease provide a detailed description for each category

2.Describe Corporate Ownership of the Unit

  1. Are the subjects all healthy normal No Yes
  1. Are the subjects part of a diseased community such as oncology or diabetes No Yes
  1. Is impartial witness allowed at this siteNo Yes
  1. Are LAR’s allowed at this siteNo Yes
  1. Building

Description:

Age: Sq. Feet:

Picture of Exterior attached? No Yes

Cleanliness:

Sleeping Area:

Common Area:

Dining Area:

Bathrooms:

  1. Food Preparation
  1. Specimen collection facilities
  1. Location Description
  1. Population

Description of general demographics

  1. Equipment

Are subject monitoring facilities appropriate

Access to/for emergency services

Restricted access/exit for subjects

Backup power supply

Equipment available

BP monitors

EKG

Defibrillators

Tilting beds

Alarm call system

Emergency trolley

Ambu bag

Aspiration equipment

IV infusion fluids

Equipment checked and calibrated regularly

Equipment appropriate

Diet Control Measures

Other

  1. Drug Storage

Drug storage area controlled access

All drugs securely stored

Equipment adequate for special storage requirements

Facilities adequate for drug storage

  1. Pharmacy

Drug storage area controlled access

All drugs securely stored

Equipment adequate for special storage requirements

Facilities adequate for drug storage

  1. Laboratory

Area Clean

Area effectively organized

Samples process according to SOPs

Storing specimens

Temperature records

Freezer connected to alarm system

Auxiliary power available in case of emergency

Samples analyzed at an approved central lab

Training

Internal QC program

Lab certification/accreditation procedures – required by local or regional agencies

Radioactive Materials Safety

  1. Data Storage

Storage

  • How: (electronic or paper)
  • How long
  1. Activities

Internet Access/Wi Fi

Games

TV

Reading Material

Books

Magazines

Personal Electronic Devices (PED)

  • Are subjects allowed to bring their own (PED’s)
  1. Separate smoking area
  1. Security Measures

Body Searches

Search of Personal Possessions

Special attire for subjects

Security Patrols

Internal

External

Video surveillance

  • Are these recordings saved?
  • How long?
  1. Emergency Procedures

Facilities

Equipment

911

Crash Cart

ACLS Trained

Nearest Hospital/ER

Ever needed? No Yes If yes explain

  1. Screening

Protocol procedures followed

Method of subject identification

Screening facilities appropriate

Study specific exams

Conducted on site

If not, where:

  1. Subject Recruitment:

Advertisements

Data Base

Call Center

Homeless Centers

Other

Do you enroll “professional” subjects?

Website:

  • Provide website address:
  • Currently approved by an IRB? No Yes Expiration date?

Referral Program:

  • Brochure available:
  • Description:
  • Amount paid to subjects:
  • Are relatives allowed to refer each other?
  • Currently approved by an IRB? No Yes Expiration date?

Telephone

Face-to-Face

Other

  1. Describe Consenting Process to include locations
  1. SOPs & Guidelines

Reviewed No Yes

Attached table of contents No Yes

Comments:

  1. Guidelines

SOPs for archiving process

Comments:

  1. Staff

Organizational Chart Attached No Yes

Training Records Attached No Yes

Staff/subjects ratio

Is someone on site at all times No Yes

How many

Roles

Doctor(s) on Site

When

How long

  1. Received copies of any Brochures or Written Information

No Yes Comments:

Do subjects carry an emergency card outside the unit

  1. Received copies of any lists of rules that subjects must follow in order to participate No Yes

Comments:

  1. AdditionalComments:

Signature of Site VisitorDate

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