STANDARD
OPERATING
PROCEDURES FOR
GOOD CLINICAL
PRACTICE AT THE
INVESTIGATIVE SITE
A PUBLICATION OF THE CENTER FOR CLINICAL RESEARCH PRACTICE, INC.
ISBN: 1-931107-55-6
Copyright © 1998, 2001, 2003 by the Center for Clinical Research Practice, Inc. All
rights reserved. This document and accompanying software may not, in whole or in part,
be copied, photocopied, reproduced, translated or reduced in any form or manner
including by any electronic, digital, or mechanical means to any medium, electronic or
otherwise, or machine readable form including any information storage, scanning, or
retrieval system without the prior, express written consent from the Center for Clinical
Research Practice, Inc.
Date of version: 07/01/2009
Replaces previous version: N/A
Approved by: _____________________________
SM - 405
STANDARD OPERATING PROCEDURE FOR
SPECIMEN COLLECTION AND HANDLING
I. INTRODUCTION AND PURPOSE
The proper collection and processing of specimens obtained from study subjects
are part of the data collected in a clinical trial. The specimens provide important
information about the drug’s action within the body and the subject’s biologic and
clinical response. To ensure accurate data, specimens must be collected at the
specified time points, processed, possibly preserved, and then shipped
appropriately. Additionally, research or ancillary staff must adhere to good
laboratory practices when collecting, processing, and arranging for shipment of
the specimens to the testing laboratory. This standard operating procedure
(SOP) describes the steps for fulfilling the regulatory and clinical requirements
involved in specimen collection and handling.
2. SCOPE
This SOP applies to the activities involved in collecting and handling specimens
from subjects enrolled in clinical studies conducted at this investigative site
subject to investigational new drug (IND) regulations for drugs and biologics
during all phases of development.
3. APPLICABLE REGULATIONS AND GUIDELINES
21 CFR 312.62
May 1997
Investigator recordkeeping and record retention
International Conference on Harmonisation; Good Clinical
Practice: Consolidated Guideline
4. REFERENCES TO OTHER APPLICABLE SOPS
SM-403
DM-501
Subject Management While on Study
Data Management
5. ATTACHMENTS
A. Order Form for Research Funded Procedures
1
SM-405, Specimen Collection and Handling
Date of version: 07/01/2009
Replaces previous version: N/A
6. RESPONSIBILITY
This SOP applies to those members of the clinical research team involved in
ensuring appropriate specimen collection and handling at this research site. This
includes the following:




Principal investigator
Sub-investigator
Clinical Research Coordinator
Lab Staff
7. DEFINITIONS
The following definitions from the International Conference on Harmonisation,
Good Clinical Practice: Consolidated Guideline apply to this SOP.
Source Data: All information in original records and certified copies of original
records of clinical findings, observations, or other activities in a clinical trial
necessary for the reconstruction and evaluation of the trial. Source data are
contained in source documents (original records or certified copies).
Source Documents: Original documents, data, and records (e.g., hospital
records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries
or evaluation checklists, pharmacy dispensing records, recorded data from
automated instruments, copies or transcriptions certified after verification as being
accurate and complete, microfiches, photographic negatives, microfilm or
magnetic media, x-rays, subject files, and records kept at the pharmacy, at the
laboratories, and at medico-technical departments involved in the clinical trial).
8. PROCESS OVERVIEW
A. Collecting the specimens
B. Processing the specimens
C. Preparing the specimens for shipping to the testing laboratory
2
SM-405, Specimen Collection and Handling
Date of version: 07/01/2009
Replaces previous version: N/A
9. PROCEDURES
A. Collecting the specimens

Clinical Research
Coordinator

Lab Staff
Per protocol:
Observing appropriate precautions based upon OSHA
guidelines, infection control manual, and/or the institutional
procedure manual for the handling of bodily fluids, collect
the appropriate specimens identified in the study protocol.
In the subject’s medical record and/or on the case report
form, note the date and time of the collection as well as any
relevant information pertaining to the subject’s status at the
time of the procedure.
Label the test tubes or other containers with subject
identifiers, date, time, and any other information required
per protocol/study guidelines.
B. Processing the specimens

Clinical Research
Coordinator

Lab Staff
Per protocol:
Process the specimen according to the specifics defined in
the protocol (for example, centrifuge speed, duration,
temperature requirements).
Spin, separate and transfer the specimen to the appropriate
transport tube(s), as required.
Label the study-specific test tubes or other containers with
subject identifiers, date, time, and any other information
required to prepare for storage or shipment.
Complete the Order Form for Research Funded Procedures
(Attachment A). Retain one copy and file with the other
study-related subject records. Forward one copy to the
Data/Finance Analyst and one copy to the appropriate
department contact person.
3
SM-405, Specimen Collection and Handling
Date of version: 07/01/2009
Replaces previous version: N/A
C. Preparing the specimens for shipping to the testing laboratory

Clinical Research
Coordinator

Lab Staff
Per protocol:
Prepare and package the specimens according to the
shipping instructions specified in the protocol and/or central
laboratory procedure manual.
Include any specific specimen shipping forms required.
Retain a copy of the shipping receipt and file with the other
study-related subject records.
4
Attachment A
Research & Innovation
200 Jefferson Ave. SE
Grand Rapids, MI 49503
Order Form for Research Funded Procedures
(Do not bill insurance)
Participant Name *:
First
Middle
Last
Date of Birth
* If new study participant – contact Pre-Registration (685-8957) to create series account
Guarantor Account #
*G
Series Account #
Study Title:
Diagnosis (indicate for each scheduled procedure):
Ordering Physician:
Printed Name
LAB Print Location:
Signature
Cardiology Report:
Please perform the following tests:
LAB:
RADIOLOGY:
PATHOLOGY:
LAB SPECIMEN HANDLING:
Processing Level I
Shipping
Processing Level II
Dry Ice
CARDIOLOGY:
Processing Level III
Scheduling Confirmation:
Date:
Location:
Additional preparation / information:
Arrival Time:
ATTN: SCHEDULER – Please FAX a copy of this form to: Saint Mary’s Centralized Scheduling – 616-685-3038
Questions?
Contact
at
Date