Office of Human Research
Page Title
SOP No.: 604 SPECIMEN MANAGEMENT |
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Author: Office of Human Research |
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Effective Date: October 1, 2007 |
Supercedes document dated: N/A |
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Last Reviewed on: N/A |
Results of Review: N/A |
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This SOP pertains to: the individuals and activities involved in collecting and handling specimens from participants enrolled in Food and Drug Administration (FDA)-regulated human subject research conducted within Thomas Jefferson University. |
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Responsibility for executing this SOP: Investigator and Designated Research Personnel |
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Approved By:
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR) |
Approved By:
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR) |
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1. PURPOSE
This procedure describes the steps for fulfilling the Investigator's instructions and other applicable regulatory and clinical requirements involved in specimen collection and handling.
2. GENERAL INSTRUCTIONS
In conducting investigator-initiated trials, the Investigator is responsible to ensure the below:
- The Investigator is responsible for ensuring that all participating clinical study sites have the requisite capability for collecting, handling, storing and retaining specimens collected from participants during and after the completion of a study.
- The Investigator or designee is responsible for assessing each potential Investigator's site for ability to comply with the Investigator's specimen management requirements.
- The Investigator and participating Investigators or their designee(s) are responsible for carrying out all study-related specimen collection procedures according to the clinical protocol and for ensuring that specimen storage and retention requirements are fulfilled.
3. SPECIFIC PROCEDURES
3.1 Specimen Collection, Labeling and Handling
- The Investigator will follow instructions in the protocol for receiving, handling, storing, disposing and shipping all study specimens, as applicable.
- Observing appropriate precautions based upon applicable regulatory guidelines (e.g., those of the Occupational Safety and Health Administration or OSHA), the infection control manual, and/or the institutional procedure manual for the handling of body fluids, key study personnel will collect the appropriate specimens identified in the protocol from each participant.
In conducting investigator-initiated trials, the Investigator is responsible to ensure the above procedures are being followed.
3.2 Specimen Retention Requirements
- The Investigator will periodically verify that specimen processing, storage and retention is within the capability of their site's laboratory facilities
- If laboratory policies or space prohibit the retention of specimens for the protocol-specified period of time, the Investigator will establish alternative storage space for specimens and advise the sponsor/ CRO
- The performance of equipment for specimen storage (refrigerator, freezer) will be monitored (e.g., daily temperature charts), with documentation of equipment monitoring retained
- The Investigator or designee will periodically verify that specimen storage requirements (e.g., storage temperature) are being met and ensure that alternatives are available in case of emergency, e.g., power failure.
4. APPLICABLE REGULATIONS AND GUIDELINES
21 CFR 312.62 |
Investigator recordkeeping and record retention |
May 1997 |
International Conference on Harmonisation; Good Clinical Practice: Consolidated Guideline |
5. REFERENCES TO OTHER APPLICABLE SOPs
SM-403 |
Subject Management While on Study |
| DM-501 | Data Management |
6. ATTACHMENTS
A. Specimen Shipping Checklist
7. DEFINITIONS AND GLOSSARY
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).
