Good Clinical Lab Practice

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  • Topic: Clinical trial, Good clinical practice, Clinical trial protocol
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Robarts Clinical Imaging Research Laboratories

STANDARD OPERATING PROCEDURE FOR
SPECIMEN HANDLING

SOP Number: GCP PM 306.02
Version Number & Date: 2nd version; 17June 2010

Effective Date:
05 July 2010

Superseded Version Number & Date (if applicable):
1st version; 24 October 2005

Review Date:
05 July 2012

Revision
Chronology:
Version Number

Version Date

Reason for Change

306.01
306.02

24 October 2005
17 June 2010

Initial Version
Review and update; compliance with Lawson SOPs

Printed Name

Signature

Date (dd/mmm/yyyy)

W ritten By:

Shayna McKay

________________

____/_____/_____

Reviewed By:

Sandra Halko

________________

____/_____/_____

Approved By:

Grace Parraga

________________

____/_____/_____

GCP 306.02
Page 1 of 5

Specimen Handling
17 June 2010

Robarts Clinical Imaging Research Laboratories
1. INTRODUCTION & PURPOSE
The proper management of human biological samples for laboratory testing and analysis is essential to assure the quality and integrity of data collected in clinical trials, as well as to protect the safety of all those who handle the samples. 2. SCOPE

This standard operating procedure (SOP) describes the procedures related to biological sample management, including the collection, processing, storage and handling.
3. APPLICABLE REGULATIONS AND GUIDELINES
Health Canada Therapeutic Products Directorate Food and Drug Regulations for Clinical Trials
FDA Code of Federal Regulations, Title 21
International Conference on Harmonisation; Good Clinical Practice: Consolidated Guidelines
Tri-Council Policy Statement; Ethical Conduct for Research Involving Humans University of Western Ontario Biosafety Guidelines and Procedures Manual 4. REFERENCES TO OTHER APPLICABLE SOPs
All SOPs are cross-referenced to this SOP.
The SOPs for the Phlebotomy Room are applicable to this SOP
5. ATTACHMENTS
There are no attachments to this SOP.
6. RESPONSIBILITY
This SOP applies to all clinical personnel involved in collecting, processing, storing or handling biological specimens.
7. DEFINITIONS
The following definitions apply to this SOP:

GCP 306.02
Page 2 of 5

Specimen Handling
17 June 2010

Robarts Clinical Imaging Research Laboratories
Source Documents: Original documents, data and records (e.g. hospital records, clinical and office charts, laboratory notes, memoranda, subject’s 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). Universal Body Substance Precautions (BSP): A system that consistently interrupts the transmission of infections thus ensuring increased protection for both patients and health care providers.

8. PROCESS OVERVIEW
A.
B.
C.
D.

Biological sample management
Collecting biological samples
Processing and storing biological samples
Preparing samples for shipment

9. PROCEDURES
A. Biological Sample Management
1. Obtain all of the sample management details from the sponsor or central laboratory if not described in the protocol, including:
a. Laboratory contact information (for central laboratories) b. Requirements for specimen collection, labelling, processing and storage
c. Supplies
d. Packaging and shipping specifications
2. The sponsor should provide detailed instructions for sample management prior to study activation. All supplies should be available prior to study activation.
3. Equipment such as centrifuges, storage refrigerators/freezers and thermometers should be calibrated and checked on a regular maintenance schedule. Service/maintenance logs should be available and updated as equipment is checked.

B. Collecting...
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