Central Lab Specimen Life Cycle
PPD provides investigative site training for personnel responsible for specimen collection, shipping and management of results. Training manuals, which are available in English, French, Spanish, German, Dutch and Italian, include:
- Information for specimens required at each visit
- The tubes, containers and supplies necessary for collection
- A summary of supplies and instructions for specimen preparation, labeling and shipment
- An outline of expected times and mechanisms by which results are returned to the sites
- A toll-free telephone number and an e-mail address of our multilingual investigator help desk
PPD's unique, simplified specimen labeling system provides a source document of specimens collected for each patient. We use a requisition system linking an individual patient with all assigned visit-specific specimens and bar codes for the duration of a study. This enhances the identification of specimens and decreases demographic and sequencing queries.
All labels for all visits for each patient are provided on one sheet, and each label on each sheet contains:
- Preprinted bar codes containing a unique patient identifier
- Color coding specifying the requested analyses for each specimen at each given protocol point
- Clearly marked space to enter patient initials and collection date and time if needed
Specimen collection supplies are provided in visit-specific unit packages, each containing the necessary items required for one patient at that given time point. Small centrifuges are available for sites if needed.
Shipping the Specimen
All shipping cartons, envelopes and absorbent material are provided and meet the current international regulations for the shipment of biological specimens. Shipments are made according to protocol requirements at ambient temperature, with refrigerant packs or dry ice. The site is supplied with appropriate preprinted air courier labels with all charges billed back to global central labs and passed through to sponsors.
Analyzing the Specimen
Routine safety and efficacy analyses are performed on the day of receipt (Monday through Saturday). Automatic re-analysis of abnormal values is performed. Strict repeat criteria (delta checks) are made if certain tests exceed defined changes from one visit to the next.
Internal and external quality controls are routinely performed and data shared as requested by clients. Our laboratories maintain College of American Pathologists (CAP), Centers for Disease Control and Prevention (CDC) and National Glycohemoglobin Standardization Program (NGSP) certifications and accreditations.
Long-term specimen storage at -70 degrees Celsius is available. PPD provides comprehensive computerized archiving of biological specimens in a secure, externally alarmed facility with an autonomous uninterruptible power supply (UPS).
PPD will arrange for collection, shipment and storage of specimens, such as tissue, bone and DNA, for special analysis or shipment to other laboratories.
PPD offers genomic and proteomic specimen collection and storage services that feature specimen separation, automated DNA extraction, quantification, -70 degrees Celsius storage and packaging for third-party vendors.
Results to Sites
Same-day routine test results are faxed upon completion. Daily site reports provide a quick specimen overview and information on all results, including respective reference ranges and flagging as required per protocol. Our flexible system allows for customization of these reports. For example, customized eligibility criteria are included on reports. They help ensure only eligible patients are enrolled or randomized per protocol specifications.
Critical or alert values are telephoned or faxed in the local language immediately to the study coordinator or designated individual, and a log is kept documenting these occurrences. At the conclusion of the study, a cumulative report may be provided upon request. Results to the sites are reviewed and queried for demographic or clinical information consistency and completeness, and only cleaned reports are issued.
Results to Clinical Team
PPD provides the medical monitors, study managers and other designated personnel secure Internet access via a proprietary system to review study progress and laboratory results for safety purposes. The global Oracle-based system provides a real time, convenient and single point-of-access for powerful customized monitoring, such as:
- Specimen status
- Cumulative or interim results reports
- Out-of-range values
- Other project-related performance management metrics
Final Database
Laboratory results are provided in conventional or SI (international system of units or Système international d'unités) units. PPD data management personnel work with clients' data management groups to ensure smooth transfer according to their requirements and schedules. Data can be delivered by any method, such as tapes, discs, modem or e-mail with encryption, with the option of CDISC, SAS or ASCII format. Interim and final database transfers occur only for clean data. Statistical review of the study data set is carried out for key laboratory markers before final transfer.
