Center for Pathology Research Services

Center for Pathology Research Services

Please submit this application to prior to beginning your research protocol. Please allow up to 2-3 weeks for the processing and approval of this application. All UCLA studies using patient medical record numbers/identifiers must be registered in CareConnect. Studies not registered in CareConnect, will not be issued a requisition until registration has been completed. Studies not using patient medical record numbers/identifiers, do not need to register in CareConnect.

Please note that samples will not be accepted/processed until this application has been approved and a research requisition is created.

STUDY INFORMATION (required)
Principal Investigator: / Phone: / Email:
Coordinator: / Phone: / Email:
Dept & Affiliation: / Dept. Code:
Mailing Address: / Mail Code:
Study Name (less than 30 characters):
CTRC Protocol # (if applicable):
Protocol Summary (Less than 100 words):
How do you plan to identify your subjects? MRN Coded or Anonymous
If using MRN, CareConnect Registration and IRB# is Required
IRB #: / IRB Expiration Date:
If by coded or anonymous ID, how would you like to receive lab results?
Fax Network Printer (preferred)
If fax, please provide fax number(s):
If network printer, please provide printer model and printer IP address:
Study start date: Study end date:
Where will your study subjects be seen?
UCLA RR UCLA SMH UCLA MED PLAZA
If it is in another area besides the ones stated above, please indicate where:
BILLING INFORMATION (required)
Grant & Fund Account # (FAU): / Recharge ID:
Billing Contact Person: / Phone: / Email:
Type of Research: NIH Funded Industry Funded Department Funded
FOR STUDIES INVOLVING BIOFLUID SPECIMENS
What type of sample?
Whole blood PLASMA SERUM URINE OTHER (Please specify):
What type of processing?
CENTRIFUGE ALIQUOTING PBMC ISOLATION None
OTHER (Complex Processing >2hrs requires a custom quote, please specify)
Do you plan to send samples on the weekends? YES NO
Will you provide the CPRS with all of the supplies? YES NO
Do you want the CPRS to ship your specimens? YES NO
NOTE: IF YOU WANT PRP TO SHIP FOR YOU, PLEASE PROVIDE SHIPPING INSTRUCTIONS, AIRBILLS AND LABELS
Will you need to store your specimens at CPRS for longer than 5 business days?
YES NO
If yes, is it Ambient Refrigerated (2-6 C) -80 C -20C Liquid Nitrogen
Will you provide the CPRS with written detailed SOP for sample handling on BIOFLUIDS?
YES NO
NOTE: PLEASE ATTACH DETAILED PROCESSING AND SHIPPING INSTRUCTIONS.
FOR STUDY INVOLVING SOLID TISSUES
If a sample for clinical research purpose only being biopsied by Interventional Radiology, do you need Cytopathology to perform an adequacy?
YES NO / Authorized staff for sample pick up:
Name:
Email Address:
Telephone Number:
Name:
Email Address:
Telephone Number:
Name:
Email Address:
Telephone Number:
Name:
Email Address:
Telephone Number:
If an adequacy is performed, do you need an official cytology report issued?
YES NO
Do you need an official Pathology report to be issued in patient’s medical record?
YES NO
If you answer NO, this is considered a research specimen only for the remainder of this section
Procedure type: Biopsies Surgery
Tissue type:
Bone Marrow CNS Eye
Others please specify:______
Sample handling instructions (e.g. snap freeze, place in media, etc): / Pathology services requested (e.g. paraffin embed, unstained slides etc): If you are requesting a limited clinical work up, please indicate if you definitely need any studies other than H&E review (i.e. molecular testing)
Biobanking services requested (e.g. long term storage, and database management etc):
Will you provide the CPRS with written detailed SOP for sample handling on TISSUE?
YES NO
NOTE: PLEASE ATTACH DETAILED PROCESSING.
FOR STUDY REQUESTING LABORATORY TESTS
If your study involves tests, you are required to provide the detailed test information for your application to be processed.
Test codes and assay information is available on our on-line laboratory manual
Cohort size: / Testing time points per subject, if applicable:
If you indicated more than one time point, is the testing the same at each time point?
YES NO (If no, indicate in the table below which visit(s) each test is performed.)
Will these samples be sent individually or in batches? YES if yes, how big is each batch: NO
Will you request any test(s) STAT? YES (if yes, please note each STAT tests below) NO
Test Name / Test Code / CPT Code / STAT? / Time Point

RESEARCH AGREEMENT

Introduction

Productive, creative and rewarding research activities between Center for Pathology Research Services (CPRS) and a researcher requires both parties to have a clear understanding of the procedures that will occur, each parties’ responsibilities and ways that the agreements can be changed, if needed. This research agreement is intended to define and document a mutual understanding of responsibilities of services provided by the CPRS for the following
investigator(s) listed in this study application.

Scope

The CPRS shall exercise its best efforts to facilitate the services set forth in (Study Name) ______(IRB protocol #)______, listed in this study application form, in accordance with this agreement.

Responsibilities

General:

1) When research activities involve more than 1 or 2 people from an investigator’s team and more than 1 or 2 people from CPRS, there is great potential for miscommunications and misunderstandings, especially when protocols are being changed. To ensure that all members of the research team (including the PI) and CPRS (including the directors and lab manager) are aware of and approve of proposed changes to existing protocols, any amendments to this agreement shall be signed and approved by both the CPRS and Investigator.

2) Our fee schedule may fluctuate over the course of the study.

3) Approved amendments should be in place within two business days.

4) Authorized signatories for the CPRS are Drs. Sarah Dry and Michelle Li.

5) Authorized signatories for the Investigator are Dr(s).______.

The Investigator is responsible for:

1) The direction of the research in accordance with applicable policies and protocols.

2) Obtaining the up-to-date pricing information from CPRS.

3) Requesting in writing and obtaining written approval from the CPRS for any changes or amendments in the approved scope of work (services requested).

4) Providing reasonable advanced notice (generally 48 hours) of any changes or amendments to the approved scope of work (services requested).

5) Providing full payment within 30 days after invoice is issued. For accounts delinquent past 30 days, CPRS reserves the right to collect late fees and cancel existing service requests.

6) Notifying the CPRS when the (Study Name)______(IRB protocol #)______has ended (email acceptable).

CPRS will not be responsible for failing to perform any unapproved changes or amendments to the written and approved scope of work (services requested). If the research team does not follow the mutually agreed upon protocols, CPRS cannot guarantee that the sample will be handled as desired, although every effort will be made to do so.

Performance Period

The period of this agreement will be effective immediately after both parties complete the signature, until CPRS receives notification from Investigator that the study has ended.

Approvals

Investigator CPRS:

Signature______Signature______

Date______Date______