Non-Smile Resource Author: Westat Document Number: Pro80-02 Effective (or Post) Date: 12-Mar-10 Document Origin Company: Westat SMILE Approved by: Jo shim Review by Heidi Hanes Review date 8-Feb-12 SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering their use in other applications. If you have any questions contact SMILE. Laboratory Study Specific Specimen Management Plan [Your Lab SOP# & Version]
Copy Number 1 SOP No: Lab Name Version 1 Supersedes: Effective Date: SOP Title: STUDY SPECIFIC SPECIMEN MANAGEMENT PLAN PRINTED NAME & SIGNATURE DATE
PREPARER
QA UNIT AUTHORITY
REVIEWING AUTHORITY
APPROVAL AUTHORITY
ANNUAL REVIEW REVIEWER SIGNATURE DATE REVIEWER SIGNATURE DATE
SOP COPY CONTROL DATE PRINTED: NUMBER OF COPIES: SOP DISTRIBUTION
By Initialing and dating below I understand and approve of the changes to the attached SOP. SOP CHANGE CONTROL Initials/Date Date/Initials Nature of Change QA LAB DIRECTOR
5/26/04 Page 2 of 7 Draft Laboratory Study Specific Specimen Management Plan [Your Lab SOP# & Version]
1. Specimen Collection
1.1. Please see [YOUR SPECIMEN COLLECTION PROCEDURE AND/OR STUDY PROTOCOL. This Specimen Collection Procedure contains details on preparation of the patient (where relevant), type and capacity of collection container and amount of specimen to be collected, types of preservatives or anticoagulants, special handling between collection and time received by the laboratory, and proper specimen labeling for all samples that will be obtained as part of [THIS STUDY].
1.2. All specimens from [YOUR SPECIMEN COLLECTION LOCATIONS] will be processed and tested (where real-time testing occurs) or stored (where appropriate) at the [YOUR STORAGE LOCATION] in [YOUR STORAGE COUNTRY]. Neither sample processing nor will laboratory testing for [THIS STUDY] occur at any other location or laboratory.
1.3. Specimens will be transported daily (Monday through Friday) from study units to the [YOUR LABORATORY] according to the 46th edition of the IATA Dangerous Goods Regulations (please see Section 4 below).
1.4. There are no special conditions under which specimens should be collected for [THIS STUDY].
2. Receipt and Storage – This section must be rewritten to be specific to your laboratory processes and may refer to specific procedures that detail each process.
2.1. Specimen worksheets will be completed each day. These worksheets will list which types (and numbers) of specimens have been collected, the participant PID/SID, and the time and date of collection. The name and signature of each study nurse or doctor who obtained the specimen will be recorded next to each specimen on the worksheet. These specimen worksheets will be faxed from each unit to the Data Management Centre on each morning that one or more laboratory specimens are being submitted. These specimen worksheets are entered (keyed) at the Collection Location into the Laboratory Information System (LIS), and are accessed on the internet by research lab staff. The specimen worksheets serve as lists of "expected samples" to be received by the laboratory later in the day. Samples received for each required test are compared with the list of expected samples using the LIS. Much QC and QA by the lab research staff is based on these systems. As all results can be handled electronically, a summary of what has and has not been resulted for the batch of samples received is available online for the lab research staff to manage the samples/results/storage.
The study Data Coordinator will keep the original specimen worksheets, and will therefore also have a record of which specimens were submitted each day.
5/26/04 Page 3 of 7 Draft Laboratory Study Specific Specimen Management Plan [Your Lab SOP# & Version] Each specimen will also be accompanied by a completed laboratory test requisition form that is specific for the Laboratory and this study.
2.2. The study laboratory research assistant will meet each specimen drop-off at the laboratory sample reception area. She will cross-check the specimen worksheet (that was previously faxed, as well as a copy of the same worksheet that will accompany the specimens) with the laboratory test requisition forms and the actual specimens received. She will also ensure that specimens received in the laboratory are properly packaged according to transport SOPs. She will furthermore ensure that the PID for each participant in the study is used for identification of the specimens and printed on self-adhesive labels. If any missing samples or missing / incorrect information is identified by the study laboratory research assistant, she will follow up as soon as possible with the study site and staff member responsible for the collection of the relevant specimen.
2.3 Laboratory specimen identification numbers are assigned at the sample receiving area at the laboratory. In the laboratory system, specimens are assigned a barcode, and the information entered onto the database is: participant ID number, participant initials, date specimen obtained, time specimen obtained, site (unit) code, visit code, clinician’s initials, group reference number (assigned by the Laboratory), type of specimen, number of tubes received, volume of specimen received, and specimen condition. Specified samples will also be issued LDMS numbers and labels.
2.4 The study laboratory research assistant will ensure that the study specimens are received by the correct areas at the laboratory for subsequent processing and testing. All samples entered electronically into the laboratory system include specimen date, time, name and signature of handler.
2.5 Written instructions are available for the following processes.
2.5.1 Proper handling of specimens (please refer to the study and laboratory test- specific SOPs)
2.5.1 Proper storage of samples; and
2.2.1. Daily recording of sample storage equipment temperatures (i.e., refrigerator, freezer, incubator, etc.).
2.6 LDMS will be used to manage and document proper transfer of samples to storage locations in the laboratory. The study laboratory research assistant will be responsible for overseeing this.
3. Recording and Tracking - This section must be rewritten to be specific to your laboratory processes and may refer to specific procedures that detail each process.
3.1. The study laboratory research assistant will be responsible for the overall tracking of samples, including time of collection, transport, processing, testing and storage.
5/26/04 Page 4 of 7 Draft Laboratory Study Specific Specimen Management Plan [Your Lab SOP# & Version] 3.2. The study laboratory research assistant, who has received IATA training, will be responsible for correcting problems identified in specimen preparation, packaging, and transportation from the study units. She will accept the submitted specimens on a daily basis from each of the two units, and will therefore know whether any problems in specimen transport exist. She will communicate immediately with the study nurse in charge of this study at each unit if a problem is identified. Regular study specific meetings will be held, at which any recurring problems will be raised and addressed.
3.3. The study laboratory research assistant will also monitor all study specimens for several other characteristics: collection in the appropriate container, collection of the appropriate amount, proper labeling, and transportation at the appropriate temperature and in the specified time frame after collection. Specimens will only be received from two units, and all of the Laboratory staff know one another and will work closely with the study laboratory research assistant. These factors will allow problems to be detected and rectified quickly.
3.4 The study laboratory research assistant will ensure that specimens are accompanied by a requisition that includes patient identifier, name and study unit of clinician ordering test, date and time specimens were obtained, site code, visit code, and tests or assays required.
4. Preparation and Packing - This section must be rewritten to be specific to your laboratory processes and may refer to specific procedures that detail each process.
4.1. Specimens will be packaged according to IATA (International Air Transportation Association) regulations when being transported from study units to the Laboratory. Specimens from the Laboratory will usually be carried over in person from the study clinic. Specimens from the Satellite laboratory will be transported by vehicle; the specimen container will be placed in a part of the vehicle that is not transporting people.
4.2. Specimens will be contained in watertight primary receptacles (collection containers), and separated from one another to avoid breakage. These primary receptacles will be placed in a watertight secondary receptacle with absorbent material. The secondary receptacles will be transported in sturdy outer packaging, either rigid coolboxes or sturdy corrugated fiberboard boxes.
4.3. Specimens for this study are generally considered diagnostic specimens, and will be labeled appropriately when being transported from study units to the laboratory.
5. Transport and Shipping - This section must be rewritten to be specific to your laboratory processes and may refer to specific procedures that detail each process.
5.1. The following specimens will be stored on site until shipping instructions are received by the site from the study team: stored plasma and PBMC for virology (resistance) testing; and pharmacokinetic sampling at the 2- and 4-week visits (as well as NVP toxicity time points) in arm 1A participants. The laboratory will await specific
5/26/04 Page 5 of 7 Draft Laboratory Study Specific Specimen Management Plan [Your Lab SOP# & Version] guidelines as to the frequency or timing of shipments of these samples, as well as plans for shipping any other samples in A5208.
5.2. Tracking Management System (to generate a specimen status report).
5.2.1 Manual tracking is used. All specimens are entered into the relevant logbooks. The Lab ID for each specimen is transcribed onto the corresponding laboratory requisition form that accompanies each specimen. The lab ID number is also present on the cryovial / specimen bottle (along with the barcode).
5.2.2 The study laboratory research assistant will be responsible for correcting problems identified in sample transportation, sample mix up, and contamination related to study samples. The laboratory director will be made aware of such problems, and has ultimate oversight of any systemic problems in the laboratory.
5.2.3 Please see the attached [Excel spreadsheet or SOP] for chain of custody of samples.
5.2.4 In case of accidents or spills en-route, the lab safety officer should be called (name) at (number). For additional information, see the laboratory specific SOPs for safety and spill decontamination.
5.3 Laboratory staff are instructed to wear protective gloves and a laboratory coat.
5.4 IATA guidelines will be followed when transporting specimens transported from clinics to the Laboratory (please see Section 4).
5.5 [YOUR SHIPPER] will be used to ship diagnostic and infectious material
5.6 Import / export permits [are / are not] required by [YOUR COUNTRY] for shipping specimens. Most of the countries to which specimens are shipped do require permits. The study laboratory research assistant will be responsible for coordinating this.
6. Training - This section must be rewritten to be specific to your laboratory processes and may refer to specific procedures that detail each process. 6.1 Each laboratory technician / research assistant undergoes competency training in using the equipment and systems that will fall under his / her purview. Competency training records are kept for each person who has undergone training. Refer to your competency training SOP for details
6.2 [Names], study laboratory research assistant, is/are certified to ship dangerous goods (trained DATE).
5/26/04 Page 6 of 7 Draft Laboratory Study Specific Specimen Management Plan [Your Lab SOP# & Version]
YOUR Transport or CLINIC Preparation Protocol Research courier specimen of Study/visit specific Laboratory service collection specific kits training
Error: clarification Registration Receiving Specimen (Specimen Labeling and verification login) processing
Storage Result Data Entry into interpretation Analysis and verification Integrity and LIS Entry checks Q.C. authorisation Ship to other laboratories
Archive/filing
Result Reporting Clinician C.D.C.
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