GLP Study Director

2016 ◽  
Author(s):  
Gerald R. Stephenson ◽  
Ian G. Ferris ◽  
Patrick T. Holland ◽  
Monica Nordberg
Keyword(s):  
Study Director

scholarly journals Modification to the AOAC Sporicidal Activity of Disinfectants Test (Method 966.04): Collaborative Study

2006 ◽  
Vol 89 (5) ◽  
pp. 1373-1397 ◽  
Author(s):  
Stephen F Tomasino ◽  
Martin A Hamilton ◽  
H Chan A Garza ◽  
M Buen ◽  
H Chan Myers ◽  
...  
Keyword(s):  
Stainless Steel ◽  
Collaborative Study ◽  
Current Method ◽  
Soil Extract ◽  
Nutrient Broth ◽  
Nutrient Agar ◽  
Garden Soil ◽  
Manganese Sulfate ◽  
Hard Surface ◽  
Study Director

Abstract In an effort to improve AOAC Method 966.04, the Sporicidal Activity of Disinfectants Test, selected modifications to the procedure were evaluated in a collaborative study. Method 966.04 is used to generate efficacy data to support the product registration of sporicides and sterilants. The method is a carrier-based test that provides a qualitative measure of product efficacy against spores of Bacillus subtilis and Clostridium sporogenes. The use of garden soil extract and the lack of standard procedures for the enumeration of spores and neutralization of the test chemicals have been considered problematic for many years. The proposed modifications were limited to the B. subtilis and hard surface carrier (porcelain penicylinder) components of the method. The study included the evaluation of a replacement for soil extract nutrient broth and an establishment of a minimum spore titer per carrier, both considered crucial for the improvement and utilization of the method. Additionally, an alternative hard surface material and a neutralization confirmation procedure were evaluated. To determine the equivalence of the proposed alternatives to the standard method, 3 medium/carrier combinations, (1) soil extract nutrient broth/porcelain carrier (current method), (2) nutrient agar amended with 5 g/mL manganese sulfate/porcelain carrier, and (3) nutrient agar amended with 5 g/mL manganese sulfate/stainless steel carrier were analyzed for carrier counts, HCl resistance, efficacy, quantitative efficacy, and spore wash-off. The test chemicals used in the study represent 3 chemical classes and are commercially available antimicrobial liquid products: sodium hypochlorite (bleach), glutaraldehyde, and a combination of peracetic acid and hydrogen peroxide. Four laboratories participated in the study. The results of the spore titer per carrier, HCl resistance, efficacy, and wash-off studies demonstrate that amended nutrient agar in conjunction with the porcelain is comparable to the current method, soil extract nutrient broth/porcelain. The nutrient agar method is simple, inexpensive, reproducible, and provides an ample supply of high quality spores. Due to the current use of porcelain carriers for testing C. sporogenes, it is advisable to retain the use of porcelain carriers until stainless steel can be evaluated as a replacement carrier material for Clostridium. The evaluation of stainless steel for Clostridium has been initiated by the Study Director. Study Director recommendations for First Action revisions are provided in a modified method.

Study-Planning with Science and Compliance as the Driving Forces

1991 ◽  
Vol 10 (3) ◽  
pp. 381-386
Author(s):  
Mildred S. Christian
Keyword(s):  
Quality Assurance ◽  
Driving Forces ◽  
Final Report ◽  
Simultaneous Application ◽  
Senior Staff ◽  
Team Members ◽  
Study Planning ◽  
Scientific Principles ◽  
End Times ◽  
Study Director

Science and compliance are not competing forces. Only by simultaneous application of scientific principles and compliance requirements can appropriate, replicable safety evaluations be produced. Our organization has developed a system, identified as Telstar, by which teams that include members from each department are assigned to each study before its initiation and continue to be involved with the study until issue of the final report. This team is identified on the basis of appropriate expertise and experience and representation of appropriate areas. The Telstar team for each study includes the study director/report coordinator, the principal technician, the animal care technician, the data specialist, the information specialist, and the quality assurance auditor. Start and end times are assigned to each study period, including protocol approval, the various phases of study conduct and critical phase audits, specific raw data audits, beginning and ending of the in-life phase meetings, preparation of intermediate and final tables, review of tables, review of report results with senior staff, report writing by the study director, submission of report to senior staff, revision times, submission of report to quality assurance for audit, final review by study director after the quality assurance audit, final review by management (including review of the quality assurance audit results for the report), and report issue. Throughout the study, various team members interact with the study director, and scheduling is checked at twice-weekly management meetings, allowing study design and milestones to be modified if necessary. Use of this project team, with the study director coordinating specialists from each area, results in a quality product that meets all needs.

Use of Total Quality Principles Can Result in Faster, Clearer, and More Accurate Reports That Are of Greater Value to the User

1991 ◽  
Vol 10 (3) ◽  
pp. 393-395
Author(s):  
Gerald A. Nixon
Keyword(s):  
Quality Assurance ◽  
Effective Means ◽  
Clear Understanding ◽  
Total Quality ◽  
Successful Completion ◽  
High Quality ◽  
Quality Principles ◽  
Pertinent Data ◽  
Study Director ◽  
Quality Approach

Successful completion of any study is the timely preparation and distribution of an accurate, understandable, and useful report. The report should include all details of study procedures and results plus conclusions based on thoughtful consideration of the data. Overall, responsibility for a study report should belong to the study director. Contributing scientists and scientific writers should work closely with the study director in establishing timing and format. Review by one or more peers is an effective means of assuring that the report is scientifically valid and that conclusions drawn are sound and accurate. Review by the quality assurance unit (QAU) helps assure that the report accurately reflects the raw data and that all pertinent data are included in the report. However, although the foregoing are necessary, they are not sufficient. It is crucial that the study director and other report contributors have a clear understanding of the expectations and needs of the sponsor before the report is assembled. A total quality approach to planning and preparing the report will result in a high-quality document.

Book Review: Interviewer versus Study Director?

2002 ◽  
Vol 1 (4) ◽  
pp. 491-495
Author(s):  
Jennifer Platt
Keyword(s):  
Study Director

scholarly journals Determination of Fluoride in Wine by Fluoride Selective Ion Electrode, Standard Addition Method: Collaborative Study

2003 ◽  
Vol 86 (6) ◽  
pp. 1203-1207 ◽  
Author(s):  
Bruno E Trombella ◽  
Arthur Caputi ◽  
Daniel Musso ◽  
Anthony Ribeiro ◽  
Timothy Ryan ◽  
...  
Keyword(s):  
Collaborative Study ◽  
Standard Addition ◽  
The United States ◽  
White Wine ◽  
Addition Method ◽  
Relative Standard ◽  
Standard Deviations ◽  
Study Director ◽  
Statistical Results

Abstract The accuracy, precision, and reproducibility of a rapid method for determination of fluoride in wine, using a fluoride selective ion electrode, were established by a collaborative study involving 12 laboratories, 5 in Europe and 7 in the United States. The laboratories assayed 6 Youden pairs of fluo-ride-fortified, red and white wine samples with fluoride concentrations ranging from 0.2 to 3.0 mg/L. The relative standard deviations of repeatability ranged from 1.94 to 4.88%; relative standard deviations of reproducibility ranged from 4.15 to 18.40%. HORRAT values ranged from 0.30 to 0.97. The average recovery was 99.97%. Based on the statistical results of this collaborative study, the Study Director recommends that this method be adopted First Action.

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