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What are the time requirements for archival storage of:
1) Non-clinical PK or TK samples
2) Clinical PK samples (plasma or urine)
Mary
Mary M Sherman, Ph.D.
Principal Consultant
Preclinical & Regulatory Consulting
67 Monadnock Drive
Westford, MA 01886
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Dear Mary-
There are no regulatory requirements in the US or EU for archival
storage of "wet" samples (plasma, blood, etc) from GLP animal studies or
clinical studies. Such samples are specifically exempted by US GLP
regulations from long term storage after analysis.
An organization may have its own policy for business reasons. For
example, most organizations will retain such samples at least until
either the final study report is issued or until the report is submitted
to a regulatory agency, or a specified time thereafter.
-Tom
Thomas L. Tarnowski, Ph.D.
Corporate Liaison & Special Tasks Director
Organizing Committee
CACO Pharmaceutical and BioScience Society
ttarnowski1.aaa.aol.com
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The following message was posted to: PharmPK
Tom / Mary,
For clinical studies (Human Samples), a number of countries have Human
Research Protection Regulations that do cover sample storage and
archiving. Not GLP / GMP. Some overlap with GCP
Most organisations will have a policy. Storage should be as agreed
in study protocol, but critically should be in line with the ICF. It
some countries storage beyond ICF timelines can be followed with IRB
approval if samples annonymised.
AnthonyAnthony Chadwick PhD
Global Human Tissue Designate
Covance Regulatory Strategy_CDS
Email: anthony.chadwick.aaa.covance.com
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The following message was posted to: PharmPK
We generally keep for 2 years and have stability for the methods to cover this.
We also keep additional Qc with samples for as long as they are stored
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Dear Sir,
We keep the plasma samples for about 1-2 years depending on the stability of the
drug/analyte in the plasma.
Dr Zafar
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