Standard Efficacy Report +

Summary Template
3/23/05
The following template may be used as a guide by testing laboratories in formatting and
summarizing efficacy study reports.
Template With Summary
Study Title
Product Identity
Data Requirement
Author
(name)
(corporate title)
Study Completion Date
(Date final report is signed by study director.)
Testing Facility
(include address)
Laboratory Project Number (Study File)
Page 1 of X
Page 2 of 13
Test Facility Name
Project No: ######
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this study on the basis of its
falling within the scope of FIFRA section 10(d)(1)(A), (B), or (C).
Company:
Company Agent: Date:
(typed name)
Title Signature
Alternate No.1:
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling within the scope of FIFRA section
10(d)(1)(A), (B), or (C) has been removed to a confidential appendix, and is cited by cross-
reference number in the body of the study.
Company:
Company Agent: Date:
(typed name)
Title Signature
Page 3 of 13
Test Facility Name
Project No: ######
GOOD LABORATORY PRACTICE COMPLIANCE STATEMENT
This study meets the requirements of 40 CFR 160.
(Alternative No.1: This study meets the requirements of 40 CFR 160 with the following
exceptions: if any exceptions during study)
(Alternative No.2: This study does not meet the requirements of 40 CFR 160. A detailed list
of exceptions must be included.)
SUBMITTER: [Insert Corporate Name]
(Signature) DATE:
Typed Name
Title
SPONSOR: [Insert Corporate Name]
(Signature) DATE:
Typed Name
Title
STUDY DIRECTOR:
(Signature) DATE:
Typed Name
Title
Page 4 of 13
Test Facility Name
Project No: ######
TABLE OF CONTENTS
Title Page.................................................................................................. 1
Statement of Confidentiality Claims................................................ 2
Good Laboratory Practice Compliance Statement............................... 3
Study Materials....................................................................................... #
Study Method #
Study Acceptance Criteria #
Data Analysis #
Study Retention. #
Study Results. #
Study Conclusion................................................................... #
Figure 3 - #: Test Results......................................................... #
Appendix 1 (other relevant information, e.g. protocol). #
Table of Contents......................................................................... 4
Efficacy Study Summary......................................................................... 5
Quality Assurance Statement 6
Study Personnel................................................................. 7
Study Report.......................................................................................... 8
Controls. #
: Control Results.................................................... # Figure 1
Figure 2: Neutralization Results.............................................. #
Page 5 of 13
Test Facility Name
Project No: ######
EFFICACY STUDY SUMMARY
STUDY TITLE: (Title of study performed including test method name)
LABORATORY PROJECT #: (Lab identification number assigned to study.)
GUIDELINE: (EPA Guideline #and label claim being supported by testing)
TESTING FACILITY: (Name of testing laboratory)
STUDY DATES:
STUDY INITIATION DATE: (Date the protocol is signed by study director)
STUDY COMPLETION DATE: (Date final report is signed by study director)
GLP COMPLIANCE: (Description of compliance with 40CFR160)
TEST SUBSTANCE:
DESCRIPTION: (Product use-pattern, as per label, and form)
% ACTIVE INGREDIENT: (Ingredient(s) name and percent claimed on label)
DILUTION: (Product dilution used in testing, include dilution instructions)
TEST CONDITIONS:
SOIL LOAD: (Organic load used in testing)
WATER: (Water type and hardness used in testing)
CONTACT TIME: (Contact time of disinfectant used in testing)
TEMPERATURE: (Temperature used in testing)
OTHER: (Describe other modifications to test, e.g. surface, additional
organisms, re-use.)
TEST RESULTS: (form - Positive carriers/total carriers, log reduction, etc.)
Test Organism
Identification
#
Test Results
(form)
Lot ##### Lot ##### Lot #####*
*60 day old Sample
CONTROL RESULTS: (Statement verifying that all controls met specifications of
method and/or protocol, reference the appropriate pages in the
study report)
CONCLUSION: (Did study meet EPA Guideline? Under what conditions?)
__________ ____________ __________________ __________________
__________ ____________ __________________ __________________
__________ ____________ __________________ __________________
__________ ____________ __________________ __________________
Page 6 of 13
Test Facility Name
Project No: ######
QUALITY ASSURANCE STATEMENT
Study Title:
Study #:
In accordance with the Good Laboratory Practice Standards (EPA 40 CFR 160), quality
assurance audits of this study were conducted and reported to management and the study director
as listed below:
Date Reported to Date Reported to
Audit Date Phase Audited Study Director Management
(Signature)
Typed Name Date
QA Title
Page 7 of 13
Test Facility Name
Project No: ######
STUDY PERSONNEL
STUDY DIRECTOR: (Signature)
Typed Name
Corporate Title
[Other scientists or professionals involved in the study must sign the report. The names of the
supervisory personnel involved in the study should be included in the final report. Names of
laboratory personnel may be included in the final report.]
Page 8 of 13
Test Facility Name
Project No: ######
STUDY REPORT
STUDY TITLE: (Brief title of the study.)
SPONSOR: (Name, Corporation Name, and address.)
TEST FACILITY: (Corporation Name and test facility address.)
TEST SUBSTANCE IDENTIFICATION
TEST SUBSTANCE NAME: (Include code number or CAS number, active
ingredient, EPA Reg. #as applicable)
LOT/BATCH NUMBER(S): (Test substance lot/batch numbers, manufacture date,
expiration date. Clearly identify the 60-day-old sample.)
DESCRIPTION OF TEST SUBSTANCE: (Describe test substance as received [i.e.
color, clarity, viscosity, concentration], container [market or otherwise as applicable],
storage conditions, and expiration date.)
CHEMICAL CHARACTERIZATION: (The identity, solubility, stability, strength,
purity, and chemical composition "was/was not" provided. Reference where the
information may be found in the submission. May be attached as an appendix if provided
to the testing facility).
STUDY INITIATION DATE: (Date the protocol signed by study director.)
EXPERIMENTAL START DATE: (First date the test substance applied to the test system.)
EXPERIMENTAL END DATE: (Last date data was collected from the system.)
STUDY COMPLETION DATE: (Date the study director signs the final report.)
STUDY OBJECTIVE: (To determine the "name of test" or "name of test substance" against
the test strains at "insert test conditions, i.e. soil, hard water, temperature, as stated in the
approved protocol)
TEST METHOD: (Official name of the test method used, i.e. AOAC Use Dilution, with the
complete citation for its publication, as stated in the approved protocol)
TEST SYSTEM/STRAINS: (Describe the test organisms, whether viral, bacterial, or fungal
strains, as stated in the approved protocol. Include source of strains.)
Page 9 of 13
Test Facility Name
Project No: ######
STUDY MATERIALS
MEDIA
(Identify each type of culture media used in the study, including neutralizing media. If using
non-standard media or modified media, describe in detail).
REAGENTS
(Identify each reagent [soil load, diluents, hard water, stains] and concentrations used in the
study. If using non-standard or modified reagents, describe in detail)
EQUIPMENT
(Identify all critical equipment used in the study.)
TEST METHOD
PREPARATION OF TEST SUBSTANCE
(Describe the preparation of the test substance. Describe in detail the dilution or special handling
required, i.e. mix x parts test substance with y parts diluent, specify by weight or by
volume).
PREPARATION OF TEST SYSTEM/STRAINS
(Describe the preparation of the test strains prior to the mixture with the test system: e.g.
dilution, spectrophotometry, pellicle removal, thawing, preparation of cell lines, addition of soil
load, drying on carriers/slides/Petri dishes)
EXPOSURE CONDITIONS
(Describe the procedure used to expose the test system to the test substance: contact time, time
variance, temperature, mixing procedure, specific quantities of all materials, and methods of
transferring liquids/carriers.)
TEST SYSTEM RECOVERY
(Describe the procedure used to neutralize and recover the test system/strain. Include time
periods, temperatures, incubation conditions, enumeration method)
PROTOCOL CHANGES
PROTOCOL AMENDMENTS
(List all Protocol Amendments [planned changes that occurred after the protocol was signed by
sponsor and Study Director] that occurred during the study. All protocol amendments must be
properly documented and may be attached along with the protocol to the final report for further
clarification.)
Page 10 of 13
Test Facility Name
Project No: ######
PROTOCOL DEVIATIONS
(List all Protocol Deviations [unforeseen circumstances/unplanned changes] that occurred during
the study. Unplanned changes are those that were not anticipated by the Sponsor or the Study
Director and thus did not go through the amendment process.)
CONTROLS
PREPARATION OF CONTROL(S)
(Describe all controls conducted in the study. Include but not limited to neutralization, sterility,
time zero, and viability. Describe the procedure, dilutions, contact times, recovery methods,
enumeration, carrier counts, neutralization, incubation parameters, and temperatures.)
STUDY ACCEPTANCE CRITERIA
STUDY REQUIREMENTS
1) List requirements for control, neutralization, strain quantification.
2) Performance criteria (To be determined by referenced published sources, i.e. EPA
documents, standard methods, or prior agreement with the agency.)
DATA ANALYSIS
CALCULATIONS
(Describe the mathematical transformation, calculations or operations performed on the raw
data.)
STATISTICAL ANALYSIS
(Describe the statistical methods used to analyze the data.)
STUDY RETENTION
Data Retention
(Describe the data retention process for your facility [final report, protocol, raw data], included
the location of the storage unit.)
Page 11 of 13
Test Facility Name
Project No: ######
Specimen Retention
(Describe the retention of the specimens for your facility, including location).
STUDY RESULTS
Control and Neutralization Results (Tables 1-2)
(Present and discuss the performance of the neutralization and carrier count controls based upon
the Study Acceptance Criteria, Method reference [AOAC, ASTM], and the EPA Guidelines.)
Study Results (Table 3 - #)
(Present and discuss the performance of the test substances based upon the Study Acceptance
Criteria and the Method Reference [AOAC, ASTM.])
STUDY CONCLUSION
(Discuss the performance of each test substance lot based upon the EPA Guidelines.)
REPORT SUBMITTED BY:
Study Director Study Completion Date
Page 12 of 13
Test Facility Name
Project No: ######
TABLE 1: Carrier Control Results
(Control Results will vary according to the Protocol. An example of Carrier Control Counts is
provided.)
TEST ORGANISM
DATE
PERFORMED
RESULT
(cfu/carrier)
TABLE 2: Neutralization Results
(Neutralization Results will vary according to the Protocol.)
NEUTRALIZATION CONFIRMATION
SAMPLE DATE INOCULUM No.
ID ORGANISM PERFORMED (cfu/mL) SUBCULTURE RESULTS
TUBES TESTED
Page 13 of 13
Test Facility Name
Project No: ######
TABLE 3: Test Results
(Tables of Test Results will vary with each study. Format to be based on data required and
expectations of sponsor.)
TEST ORGANISM
IDENTIFICATON
#
TEST RESULTS
(form)
Lot ##### Lot ##### Lot #####*
* 60day old sample