Guidelines on good clinical laboratory practice: Bridging operations between research and clinical research laboratories

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Journal of Pharmaceutical and Biomedical Analysis (Impact Factor: 2.98). 02/2008; 46(1):18-29. DOI: 10.1016/j.jpba.2007.10.010
Source: PubMed


A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting.

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Available from: Isaac Rodriguez-Chavez, Mar 11, 2014
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    • "Training: To standardize PBMC isolation and cryopreservation, each site-affiliated laboratory operated in compliance with required standards for GCLP (Ezzelle et al., 2008; Sarzotti-Kelsoe et al., 2009; Stiles et al., 2003). Operators used identical CHAVI central standard operating procedures (SOPs) for the processing, labeling, transport and storage of PBMC specimens. "
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    ABSTRACT: The Center for HIV/AIDS Vaccine Immunology (CHAVI) consortium was established to determine the host and virus factors associated with HIV transmission, infection and containment of virus replication, with the goal of advancing the development of an HIV protective vaccine. Studies to meet this goal required the use of cryopreserved Peripheral Blood Mononuclear Cell (PBMC) specimens, and therefore it was imperative that a quality assurance (QA) oversight program be developed to monitor PBMC samples obtained from study participants at multiple international sites. Nine site-affiliated laboratories in Africa and the USA collected and processed PBMCs, and cryopreserved PBMC were shipped to CHAVI repositories in Africa and the USA for long-term storage. A three-stage program was designed, based on Good Clinical Laboratory Practices (GCLP), to monitor PBMC integrity at each step of this process. The first stage evaluated the integrity of fresh PBMCs for initial viability, overall yield, and processing time at the site-affiliated laboratories (Stage 1); for the second stage, the repositories determined post-thaw viability and cell recovery of cryopreserved PBMC, received from the site-affiliated laboratories (Stage 2); the third stage assessed the long-term specimen storage at each repository (Stage 3). Overall, the CHAVI PBMC QA oversight program results highlight the relative importance of each of these stages to the ultimate goal of preserving specimen integrity from peripheral blood collection to long-term repository storage.
    Journal of Immunological Methods 06/2014; 409. DOI:10.1016/j.jim.2014.05.013 · 1.82 Impact Factor
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    • "This haemoglobin range may serve in this area as standard for interpretation of laboratory results. This study has not only allowed the definition of haemoglobin ranges for a rural area in Ethiopia, but also provided evidence that reference intervals from one population should not be applied universally [31]. "
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    ABSTRACT: Knowledge of appropriate reference intervals is critical not only to provide optimal clinical care, but also to enrol populations in medical research. The aim of this study was to generate normal ranges of laboratory values for haemoglobin among healthy Ethiopian adults and children and to determine if anaemia is a possible indicator of malaria in women and children in this area of Ethiopia. This study was carried out from January to May 2010. The reference sample population with malaria-negative consisted of 454 individuals, divided women, men and children. The malaria-infected sample population consisted of 117 individuals. The reference ranges were based on the guidelines from the Clinical and Laboratory Standards Institute. Haemoglobin concentration was determined by Hemo-Control EKF Diagnostic Analyser on whole blood. Testing for malaria-positive and negative infection was done by microscopy and by PCR. The lower limits for adult haemoglobin range obtained from this population were slightly higher than those derived from other African populations, but were equal to those established by other studies in Ethiopia and the World Health Organization (WHO). Regarding children, the minimum values were lower than those obtained from different African populations and those established by WHO. The malaria-negative group had anaemia in 35.6% of cases and in the malaria-positive group in 70.9%. There was a stronger, statistically significant association between anaemia and malaria-positive samples than between anaemia and malaria-negative samples in women and both groups of children. The results from this study are a contribution in the definition of the haemoglobin parameters in African populations, which could be taken as standards for interpretation of laboratory results. The haemoglobin indices in adults from Gambo tended to be higher than other African populations and in children were lower than other studies in Africa. The results also suggest that anaemia is not useful as a supportive diagnostic criterion to monitor and evaluate malaria in women and children from Ethiopia, because a 29.1% of malaria cases will be not detected, because of not having anaemia.
    Malaria Journal 12/2013; 12(1):435. DOI:10.1186/1475-2875-12-435 · 3.11 Impact Factor
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    • "External Quality Assurance (EQA) Programs serve three purposes according to GCLP guidance: 1) provide a way for laboratories to ensure that data generated are timely, accurate, and clinically appropriate; 2) provide sponsors with assurance that data generated are of the highest quality; and 3) ensure that human specimens from clinical trials will be tested accurately and reliably (Ezzelle et al., 2008). Although GCLP is a robust set of guidelines governing the conduct of endpoint assays for clinical trials, there are no specific statements regarding the management of external proficiency testing programs. "
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    ABSTRACT: The EQAPOL Contract was awarded to Duke University to develop and manage global proficiency testing programs for flow cytometry-, ELISpot-, and Luminex bead-based assays (cytokine analytes), as well as create a genetically diverse panel of HIV-1 viral cultures to be made available to National Institute of Health (NIH) researchers. As a part of this contract, EQAPOL was required to operate under Good Clinical Laboratory Practices (GCLP) that are traditionally used for laboratories conducting endpoint assays for human clinical trials. EQAPOL adapted these guidelines to the management of proficiency testing programs while simultaneously incorporating aspects of ISO/IEC 17043 which are specifically designed for external proficiency management. Over the first two years of the contract, the EQAPOL Oversight Laboratories received training, developed standard operating procedures and quality management practices, implemented strict quality control procedures for equipment, reagents, and documentation, and received audits from the EQAPOL Central Quality Assurance Unit. GCLP programs, such as EQAPOL, strengthen a laboratory's ability to perform critical assays and provide quality assessments of future potential vaccines.
    Journal of immunological methods 10/2013; DOI:10.1016/j.jim.2013.09.012 · 1.82 Impact Factor
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