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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Protocol and Conduct

Comparison of FDA, EPA, OECD GLP Protocol & Conduct
Topic FDA EPA OECD
Requirement
for a Protocol
58.120
(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study.
792.120
(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study.
Section II
8.1.1. For each study, a written plan should exist prior to the initiation of the study. The study plan should be approved by dated signature of the Study Director and verified for GLP compliance by Quality Assurance
personnel as specified in Section 2.2.1.b., above. The study plan should also be approved by the test facility management and the sponsor, if required by national regulation or legislation in the country where the study is being performed.
Protocol
Content
58.120
  1. The protocol shall contain, as applicable, the following information:
    1. A descriptive title and statement of the purpose of the study.
    2. Identification of the test and control articles by name, chemical abstract number, or code number.
    3. The name of the sponsor and the name and address of the testing facility at which the study is being conducted.
    4. The number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.
    5. The procedure for identification of the test system.
    6. A description of the experimental design, including the methods for the control of bias.
    7. A description and/or identification of the diet used in the study as well as solvents, emulsifiers, and/or other materials used to solubilize or suspend the test or control articles before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.
    8. Each dosage level, expressed in milligrams per kilogram of body weight or other appropriate units, of the test or control article to be administered and the method and frequency of administration.
    9. The type and frequency of tests, analyses, and measurements to be made.
    10. The records to be maintained.
    11. The date of approval of the protocol by the sponsor and the dated signature of the study director.
    12. A statement of the proposed statistical methods to be used.
792.120
  1. The protocol shall contain but shall not necessarily be limited to the following information:
    1. A descriptive title and statement of the purpose of the study.
    2. Identification of the test, control, and reference substance by name, chemical abstracts service (CAS) number or code number.
    3. The name and address of the sponsor and the name and address of the testing facility at which the study is being conducted.
    4. The proposed experimental start and termination dates.
    5. Justification forselection of the test system.
    6. Where applicable, the number, body weight, sex, source of supply, species, strain, substrain, and age of the test system.
    7. The procedure for identification of the test system.
    8. A description of the experimental design, including methods for the control of bias.
    9. Where applicable, a description and/or identification of the diet used in the study as well as solvents, emulsifiers and/or other materials used to solubilize or suspend the test, control, or reference substances before mixing with the carrier. The description shall include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.
    10. The route of administration and the reason for its choice.
    11. Each dosage level, expressed in milligrams per kilogram of body or test system weight or other appropriate units, of the test, control, or reference substance to be administered and the method and frequency of administration.
    12. The type and frequency of tests, analyses, and measurements to be made.
    13. The records to be maintained.
    14. The date of approval of the protocol by the sponsor and the dated signature of the study director.
    15. A statement of the proposed statistical method.

Section II
8.2 The study plan should contain, but not be limited` to the following information:

  1. Identification of the Study, the Test Item and Reference Item
    1. A descriptive title;
    2. A statement which reveals the nature and purpose of the study;
    3. Identification of the test item by code or name (IUPAC; CAS number, biological parameters, etc.);
    4. The reference item to be used.
  2. Information Concerning the Sponsor and the Test Facility.
    1. Name and address of the sponsor;
    2. Name and address of any test facilities and test sites involved;
    3. Name and address of the Study Director;
    4. Name and address of the Study Director;
    5. Name and address of the Study Director;
    6. Name and address of the Study Director;
    7. Name and address of the Principal Investigator(s), and the phase(s) of the study delegated by the Study Director and under the responsibility of the Principal Investigator(s).
  3. Dates
    1. The date of approval of the study plan by signature of the Study Director. The date of approval of the study plan by signature of the test facility management and sponsor if required by national regulation or legislation in the country where the study is being performed.
    2. The proposed experimental starting and completion dates.
  4. Test Methods
    Reference to the OECD Test Guideline or other test guideline or method to be used.
  5. Issues (where applicable)
    1. The justification for selection of the test system;
    2. Characterisation of the test system, such as the species, strain, substrain, source of supply, number, body weight range, sex, age and other pertinent information;
    3. The method of administration and the reason for its choice;
    4. The dose levels and/or concentration(s), frequency, and duration of administration/ application; e) Detailed information on the experimental design, including a description of the chronological procedure of the study, all methods, materials and conditions, type and frequency of analysis, measurements, observations and examinations to be performed, and statistical methods to be used (if any).
  6. Records
    A list of records to be retained.
Protocol Amendment 58.120
(b) All changes in or revisions of an approved protocol and the reasons therefore shall be documented, signed by the study director, dated, and maintained with the protocol.
792.120
(b) All changes in or revisions of an approved protocol and the reasons therefor shall be documented, signed by the study director, dated, and maintained with the protocol.
Section II
8.1.2.
a) Amendments to the study plan should be justified and approved by dated signature of the Study Director and maintained with the study plan.
Protocol
Deviation
    Section II
8.1.2.
b) Deviations from the study plan should be described, explained, acknowledged and dated in a timely fashion by the Study Director and/or Principal Investigator(s) and maintained with the study raw data.
Protocol for
Short-term
Studies
    Section II
8.1.3. For short-term studies, a general study plan accompanied by a study specific supplement may be used.
Conduct of a
Study in
Accordance
with the
Protocol
58.130
(a) The nonclinical laboratory study shall be conducted in accordance with the protocol.
792.130
(a) The study shall be conducted in accordance with the protocol.
Section II
8.3.2. The study should be conducted in accordance with the study plan.
Test System
Conformity
with the
Protocol
58.130
(b) The test systems shall be monitored in conformity with the protocol.
792.130
(b) The test systems shall be monitored in conformity with the protocol.
 
Labeling of
Specimens
58.130
(c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data.
792.130
(c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data.
Section II
8.3.1. A unique identification should be given to each study. All items concerning this study should carry this identification. Specimens from the study should be identified to confirm their origin. Such identification should enable traceability, as appropriate for the specimen and study.
Availability of
Gross Findings
to Pathologists
58.103
(d) Records of gross findings for a specimen from postmortem observations should be available to a pathologist when examining that specimen histopathologically.
792.130
(d) In animal studies where histopathology is required, records of gross findings for a specimen from postmortem observations shall be available to a pathologist when examining that specimen histopathologically.
 
Manual
Recording of
Data
58.130
(e) All data generated during the conduct of a nonclinical laboratory study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data.
792.130
(e) All data generated during the conduct of a study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the day of entry and signed or initialed by the person entering the data.
Section II
8.3.3. All data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. These entries should be signed or initialled and dated.
Changes to
Manually
Recorded
Data
58.130
(e) Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change.
792.130
(e) Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change.
Section II
8.3.4. Any change in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the individual making the change.
Automated
Recording of
Data
58.130
(e) In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input.
792.130
(e) In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input.
Section II
8.3.5. Data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries.
Changes to
Data
Recorded by
Automated
Systems
58.130
(e) Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.
792.130
(e) Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified.
Section II
8.3.5. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons having made those changes, for example, by use of timed and dated (electronic) signatures. Reason for changes should be given.