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SRI Clinical Analysis Laboratory Client Handbook

SRI Clinical Analysis Laboratory Phone: 650.859.2335 Fax: 650.859.5644

E-mail: clinical-analysis@ clinicalanalysis

GLP AND NON-GLP CLINICAL LABORATORY SERVICES Preclinical and clinical research services Excellent turnaround time More than thirteen years of exceptional service Competitive prices

Welcome to SRI Clinical Analysis Laboratory

Dear Valued Customer:

Thank you for selecting SRI International as a provider for your preclinical and clinical research studies. The Clinical Analysis Laboratory is a fully GLP-compliant clinical testing laboratory that offers a variety of standard and specialized research services. We provide high-quality service and our staff strives to exceed your expectations.

Prior to joining SRI in 2006, the Clinical Analysis Laboratory had already established itself under the name of Quality Clinical Labs (QCL) as the premier Northern California clinical laboratory for a large number of clients since 1997. The laboratory specializes in providing both GLP and nonGLP clinical laboratory services to the San Francisco Bay Area research community and beyond, with expertise in clinical chemistry, hematology, coagulation, urinalysis, and specialized biomarkers. We are dedicated to excellence in science and compliance to offer a better choice for clinical laboratory services.

We have a proven record of proficiency testing from the College of American Pathologists (CAP). The laboratory's qualified scientists are available to respond to your technical needs.

SRI Clinical Analysis Laboratory offers a daily courier pick-up within the San Francisco Bay Area, and electronic data transmission to ensure excellent turnaround times.

Our technical services are summarized in the enclosed directory. Please contact us at 650-859-2335 for further assistance.

Thank you for your business. We look forward to working with you.

Sincerely,

SRI's Clinical Analysis Laboratory

Table of Contents

Clinical Laboratory Services Our Mission and Commitment ............................................................... 3 Client Process Overview ........................................................................ 4 Courier Pick-up Service ......................................................................... 5 Overnight Shipments ............................................................................. 6 Turnaround Times ................................................................................. 7 Storage Options and Return Policy......................................................... 8 Specimen Guidelines Needle Sizes ......................................................................................... 9 Guide for Collection Tubes ...............................................................10-12 Collection, Processing, Storage and Transportation Techniques........13-18 Submissions Submittal Forms Overview ....................................................................19 Guidelines for Completing Submittal Form ........................................20-21 Frequently Asked Questions (FAQs).............................................22-24 Agreement for Clinical Research Testing Service ........................25-29

Pricing Information Request a current price list by contacting the lab via e-mail at clinical-analysis@ or by calling 650-859-2335.

SRI Clinical Analysis Laboratory Phone: (650) 859-2335 | Fax: (650) 859-5644 | Email: clinical-analysis@

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Clinical Laboratory Services

Our Mission and Commitment Mission Statement We will provide the best quality for clinical laboratory services at the fairest price to our clients. Commitment We provide quality documentation to raw data packages for nonGLP or GLP studies, in compliance with all relevant regulations and standards. All GLP data are inspected by Quality Assurance (QA) specialists in compliance with Good Laboratory Practices under 21 CFR Part 58. Licensed and certified clinical laboratory scientists monitor, review, and approve all testing processes. We have continuous success records in College of American Pathologists (CAP) proficiency programs.

SRI Clinical Analysis Laboratory Phone: (650) 859-2335 | Fax: (650) 859-5644 | Email: clinical-analysis@

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Clinical Laboratory Services

Client Process Overview

STEP 1: OPEN AN ACCOUNT

1. Complete the Client & Credit Application Form. 2. Obtain account number from SRI International.

STEP 2: START OF STUDY

1. Schedule the study with shipment options (e.g., courier, client drop-off, outside shipping vendors for overnight shipments, etc.).

2. Complete the submittal form with all the required information (see page 19).

3. For GLP studies, submit a signed final protocol, and indicate the end of study date.

4. A request for estimated quote is available.

STEP 3: SUBMITTING SAMPLES

1. Client must ensure the person(s) responsible for packing and shipping are appropriately trained in the transportation of hazardous materials (e.g., as required by 49 C.F.R. Part 172 Subpart H).

2. Include the following forms outside of the package (Forms can be found on our website): - Submittal Form - Exempt Human/Animal Specimens Form - Courier Package Integrity Log

STEP 4: END OF STUDY

1. Results will be submitted to clients; addressed to individuals listed on submittal form in Microsoft Excel format according to the requested turnaround time (see page 8).

2. GLP study book and all pertinent peripheral blood smears will be returned to clients after completion of QA Inspection and final review by the study director(s).

3. Non-GLP raw data packet will be returned after electronic data transmission of the last submission for any given study (if requested).

SRI Clinical Analysis Laboratory Phone: (650) 859-2335 | Fax: (650) 859-5644 | Email: clinical-analysis@

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