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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Records and Reports

Comparison of FDA, EPA, OECD GLP Records & Reports
Topic FDA EPA OECD
Final Report for
each Study
58.185
(a) A final report shall be prepared for each nonclinical laboratory study
792.185
(a) A final report shall be prepared for each study
Section II
9.1.1. A final report should be prepared for each study. In the case of short term studies, a standardised final report accompanied by a study specific extension may be prepared.
Content of
Final Report

58.185
(a) A final report shall be prepared for each nonclinical laboratory study and shall include, but not necessarily be limited to, the following:

  1. Name and address of the facility performing the study and the dates on which the study was initiated and completed.
  2. Objectives and procedures stated in the approved protocol, including any changes in the original protocol.
  3. Statistical methods employed for analyzing the data.
  4. The test and control articles identified by name, chemical abstracts number or code number, strength, purity, and composition or other appropriate characteristics.
  5. Stability of the test and control articles under the conditions of administration.
  6. A description of the methods used.
  7. A description of the test system used. Where applicable, the final report shall include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used
    for identification.
  8. A description of the dosage, dosage regimen, route
    of administration, and duration.
  9. A description of all circumstances that may have affected the quality or integrity of the data.
  10. The name of the study director, the names of other scientists or professionals, and the names of all supervisory personnel, involved in the study.
  11. A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.
  12. The signed and dated reports of each of the individual scientists or other professionals involved in the study.
  13. The locations where all specimens, raw data, and the final report are to be stored.
  14. The statement prepared and signed by thequality assurance unit as described in Sec. 58.35(b)(7).
792.185
(a) A final report shall be prepared for each study and shall include, but not necessarily be limited to, the following:
  1. Name and address of the facility performing the study and the dates on which the study was initiated and was completed, terminated, or discontinued.
  2. Objectives and procedures stated in the approved protocol, including any changes in the original protocol.
  3. Statistical methods employed for analyzing the data.
  4. The test, control, and reference substances identified by name, chemical abstracts service (CAS) number or code number, strength, purity, and composition, or other appropriate characteristics.
  5. Stability, and when relevant to the conduct of the study, the solubility of the test, control, and reference substances under the conditions of administration.
  6. A description of the methods used.
  7. A description of the test system used. Where
    applicable, the final report shall include the number of animals or other test organisms used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification.
  8. A description of the dosage, dosage regimen, route of administration, and duration.
  9. A description of all circumstances that may have affected the quality or integrity of the data.
  10. The name of the study director, the names of other scientists or professionals and the names of all supervisory personnel, involved in the study.
  11. A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.
  12. The signed and dated reports of each of the individual scientists or other professionals involved in the study, including each person who, at the request or direction of the testing facility or sponsor,
    conducted an analysis or evaluation of data or
    specimens from the study after data generation was
    completed.
  13. The locations where all specimens, raw data, and the final report are to be stored.
  14. The statement prepared and signed by the quality
    assurance unit as described in Sec. 792.35(b)(7).

Section II
9.2 Content of the Final Report
The final report should include, but not be limited to, the following information:

  1. Identification of the Study, the Test Item and Reference Item
    1. A descriptive title;
    2. Identification of the test item by code or name (IUPAC, CAS number, biological parameters, etc.);
    3. Identification of the reference item by name;
    4. Characterisation of the test item including purity, stability and homogeneity.
  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 Principal Investigator(s) and the phase(s) of the study delegated, if applicable;
    5. Name and address of scientists having contributed reports to the final report.
  3. Dates
    Experimental starting and completion dates.
  4. Statement
    A Quality Assurance Programme statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the Study Director and Principal Investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.
  5. Description of Materials and Test Methods
    1. Description of methods and materials used;
    2. Reference to OECD Test Guideline or other test guideline or method.
  6. Results
    1. A summary of results;
    2. All information and data required by the study plan;
    3. A presentation of the results, including calculations and determinations of statistical significance;
    4. An evaluation and discussion of the results and, where appropriate, conclusions.
  7. Storage
    The location(s) where the study plan, samples of test and reference items, specimens, raw data and the final report are to be stored.
Reports of
Individual
Scientists or
Other
Professionals
58.185
(a)
(12) The signed and dated reports of each of the individual scientists or other professionals involved in the study.
792.185
(a)
(12) The signed and dated reports of each of the individual scientists or other professionals involved in the study, including each person who, at the request or
direction of the testing facility or sponsor, conducted an
analysis or evaluation of data or specimens from the
study after data generation was completed.
Section II
9.1.2. Reports of Principal Investigators or scientists involved in the study should be signed and dated by them.
Signining of
the Final
Report
58.185(b)
The final report shall be signed and dated by the study director.
792.185
(b) The final report shall be signed and dated by the study director.
Section II
9.1.3. The final report should be signed and dated by the Study Director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with these Principles of Good Laboratory Practice should be indicated.
Corrections &
Additions to
the Final
Report
58.185
(c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible.
792.185
(c) Corrections or additions to a final report shall be in the form of an amendment by the study director. The amendment shall clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and shall be signed and dated by the person responsible. Modification of a final report to comply with the submission requirements of EPA does not constitute a correction, addition, or amendment to a final report.
Section II
9.1.4. Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the Study Director.
Reformatting
of the Final
Report
    Section II
9.1.5. Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report.
Copies of the
Final Report
  792.185
(d) A copy of the final report and of any amendment to it shall be maintained by the sponsor and the test facility.
 
Storage &
Retrieval of
Records &
Data
58.190
(a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained.
792.190
(a) All raw data, documentation, records, protocols, specimens, and final reports generated as a result of a study shall be retained. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, and biological fluids, do not need to be retained after quality assurance verification. Correspondence and other documents relating to interpretation and evaluation of data, other than those documents contained in the final report, also shall be retained.

Section II
10.1. The following should be retained in the archives for the period specified by the appropriate authorities:

  1. The study plan, raw data, samples of test and reference items, specimens, and the final report of each study;
  2. Records of all inspections performed by the Quality Assurance Programme, as well as master schedules;
  3. Records of qualifications, training, experience and job descriptions of personnel;
  4. Records and reports of the maintenance and calibration of apparatus;
  5. Validation documentation for computerised systems;
  6. The historical file of all Standard Operating Procedures;
  7. Environmental monitoring records.
Archives 58.190
(b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations.
792.190
(b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents of specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations.
Section II
3.4. Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration.
Archivist 58.190
(c) An individual shall be identified as responsible for the archives.
792.190
(c) An individual shall be identified as responsible for the archives.
 
Authorization
to Enter
Archives
58.190
(d) Only authorized personnel shall enter the archives.
792.190
(d) Only authorized personnel shall enter the archives.
Section II
10.3. Only personnel authorised by management should have access to the archives. Movement of material in and out of the archives should be properly recorded.
Indexing of
Archive
58.190
(e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval.
792.190
(e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval.
Section II
10.2 Material retained in the archives should be indexed so as to facilitate orderly storage and retrieval..
Record
retention
period

58.195

  1. Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter.
  2. Except as provided in paragraph (c) of this section, documentation records, raw data and specimens pertaining to a nonclinical laboratory study and required to be made by this part shall be retained in the archive(s) for whichever of the following periods is shortest:
    1. A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and Drug Administration. This requirement does not apply to studies supporting investigational new drug applications (IND's) or applications for investigational device exemptions (IDE's), records of which shall be governed by the provisions of paragraph (b)(2) of this section.
    2. A period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted to the Food and Drug Administration in support of an application for a research or marketing permit.
    3. In other situations (e.g., where the nonclinical laboratory study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued.

792.195
(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this subchapter.

(b)

  1. Except as provided in paragraph (c) of this section, documentation records, raw data, and specimens pertaining to a study and required to be retained by this part shall be retained in the archive(s) for a period of at least ten years following the effective date of the applicable final test rule.
  2. In the case of negotiated testing agreements, each
    agreement will contain a provision that, except as
    provided in paragraph (c) of this section,
    documentation records, raw data,and specimens pertaining to a study and required to be
    retained by this part shall be retained in the archive(s)
    for a period of at least ten years following the
    publication date of the acceptance of a negotiated
    test agreement.
  3. In the case of testing submitted under section 5,
    except for those items listed in paragraph (c) of this
    section, documentation records, raw data, and
    specimens pertaining to a study and required to be
    retained by this part shall be retained in the archive(s)
    for a period of at least five years following the date on
    which the results of the study are submitted to the
    agency.
Section II
10.1. In the absence of a required retention period, the final disposition of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry
of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation.
Retention of
Wet
Specimens
58.195
(c) Wet specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids), samples of test or control articles, and specially prepared material, which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. In no case shall retention be required for longer periods than those set forth in paragraphs (a) and (b) of this section.
792.195
(c) Wet specimens, samples of test, control, or reference substances, and specially prepared material which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. Specimens obtained from mutagenicity tests, specimens of soil, water, and plants, and wet specimens of blood, urine, feces, biological fluids, do not need to be retained after quality assurance verification. In no case shall retention be required for longer periods than those set forth in paragraph (b) of this section.
 
Retention of
Master
Schedule,
Copies of
Protocols, &
Records of QA
Inspections
58.195
(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by Sec. 58.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a) and (b) of this section.
792.195
(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by Sec. 792.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraph (b) of this section.
 
Retention
Training
records & Job
Descriptions
58.195
(e) Summaries of training and experience and job descriptions required to be maintained by Sec. 58.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraphs (a) and (b) of this section.
792.195
(e) Summaries of training and experience and job descriptions required to be maintained by Sec. 792.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraph (b) of this section.
 
Retention of
Equipment
Records & Reports
58.195
(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by Sec. 58.63(b) and (c), shall be retained for the length of time specified in paragraph (b) of this section.
792.195
(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by Sec. 792.63 (b) and (c), shall be retained for the length of time specified in paragraph (b) of this section.
 
Retention of
True Copies of
Records
58.195
(g) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.
792.195
(i) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.
 
Retention of
Records When
a Facility Goes
Out of Business
58.195
(h) If a facility conducting nonclinical testing goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The Food and Drug Administration shall be notified in writing of such a transfer.
792.195
(g) If a facility conducting testing or an archive contracting facility goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The EPA shall be notified in writing of such a transfer.
Section II
10.4. If a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor(s) of the study(s).
Waiver of
Retention of
Retention
Requirements
  792.195
(h) Specimens, samples, or other non-documentary materials need not be retained after EPA has notified in writing the sponsor or testing facility holding the materials that retention is no longer required by EPA. Such notification normally will be furnished upon request after EPA or FDA has completed an audit of the particular study to which the materials relate and EPA has concluded that the study was conducted in accordance with this part.