Document GKOJbMabney5bqok9Y6yw588n

CMA INTEROFFICE MEMORANDUM February 10, 1992 TO: CHEMSTAR Panel Managers FROM : Sandra Tirey, SUBJECT: Guidelines fj ir Good Epidemiology Practices for Occupational and Environ mtal Epidemiologic Research The "Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research," developed by CMA's Epidemiology Task Group, were published in the December 1991 issue of the Journal of Occupational Medicine (Volume 33, No. 12, PP 1221-9). A copy is attached. The Guidelines for Good Epidemiology Practices (GEPs) propose minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The GEPs address the process of conducting individual epidemiologic studies and do not prescribe specific research methods. The GEPs are analogous to the good laboratory practices (GDPs) for toxicologic research. Because the GEPs are now part of the peer-reviewed scientific literature, please consider using the GEPs the next time a CHEMSTAR panel proposes conducting an epidemiologic study. If you have any questions, please give me a call at ext. 1274, cc: (with attachments) R. Ondocsin L. Spurlock G. Strickland (w/o attachments) M. Mullins CORPORATE SAFETY MAR 9 1992 ANO HEALTH OEPT. GENC 00.53d8 r e Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research ce 99 JP ry 9- 30k The Chemical Manufacturers Association's Epidemiology Task Group The Guidelines for Good Epidemiology Practice* (GEPs) for Occupational and Environmental Epidemiologic Research ad dress the conduct of studies generally undertaken to answer questions about human health in relationship to the workplace or the environment. The GEPs propose minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The GEPs address the process of conducting individual epidemio logic studies and do not prescribe specific research methods. The Guidelines for Good Epidemiology Practices propose minimum practices and procedures in the following areas: I. Organisation and Personnel II. Facilities. Resource Commitment, and Contractors III. Protocol IV. Review and Approval V Study Conduct VI. Communication VII. Archiving VIII. Quality Assurance During the divilopmmt of the QuidoUna* for Good Epidemiology Practicaa. tha following raaaarohara warn mnmbara of CMA't Epide miology Tank Group William J. Ballajr. MPH. Chavroa Corporation: Claudia Barnar. BS. Exxoa Biomadlcal Sclasoaa. Inc: lames 1. Collina, PhD. Monaanto Company; Balph K. Cook. MD. MTH. Tha Dow Cham* ical Company: Barbara J. Ohio*. PhD. Tanano Ian; Harry Eaohanbaeh. MS. Grmca Spaelalt; Chaaloala Company; WUUam E. Payarwaathar, PhD. MPH. E. I. du Pont da Namoura and Co. Inc. (Chairman, Epidemiology Taak Group); Lorralna Lucan, PhD, Amarlean Cyanamld Company; M. Garald On. PhD, BAST Corporation: Qnrhard K. Raabo, Dr PH. MB. Mobil Corporation: Robert Schnattar. PhD, Exxon Blomadical Sciancaa, Inc: Sandra Salanakaa, PhD, Union Carbido Chamloala * Plaatica Company Inc: M. Jana Tata. Dr PH. Union Carblda ChamIrala A Plaatica Company Inc; William Thar. MD. Exxon Biomedical Scitncaa. Inc: Sandra L. Tlrny. MS. Chemical Manufacturer! Aaaociatlon. Addreaa correapondanca to Dr William E. Payarwaathar, E. L du Pont da Namoura and Co. N-11810-HH. 1007 Market Street. Wilming ton. DE 1969S. COM. 1730/91/3312-1381*00.00/0 Copyrifhi (. by American College of Occupational Medicine Although the Ouidelinee for Good Epidemiology Practices will not guarantee good epidemiology, they do provide a useful framework for ensuring that all reaaarch ieauea are adequately addraeaad. Thin framework ie proposed an a first step in improving epidemiologic research practices through adher ence to sound scientific reaaarch principlaa. Appendices provide an overview of standard operating procedurea, a gloaaary of terms used in the Guidelines, and suggested references on occupational epidemiology methods. Epidemiologic studies provide unique, valuable infor mation about the relationship between human health and ezpoeure to substances in the environment and the workplace. While the contributions of toxicology and epidemiology are complementary, there is general agreement that reliable human evidence (epidemiologic studies) should take precedence over animal data (tox icological studies) in public policy and regulatory deci sion making. However, because of the nonexperimental nature of occupational and environmental epidemiologic studies, scientific controversy often surrounds the inter pretation and significance of epidemiologic study re sults. In addition, controversy frequently concerns the quality of the data used, the appropriateness of the study design, and the process used to conduct the study. The nonexperimental nature of the epidemiologic stud ies cannot be changed, but the value of such research can be improved. The Ouidelinee for Good Epidemiology Practices address those issues---data quality, study de sign. and etudy conduct--that are under the control of the investigator. Goals for the GuMeHnas for Good EpkJemiolofly Practice* The Ouidelinee for Oood Epidemiology Practices (OEPs) address the conduct of studies generally under Journal of Occupati nal Medicino/Volumo 33 No. 12/Docombor 1991 1221 GENC 00534? taken to answer questions about human health in rela tionship to the workplace or the environment. The GEPs propose minimum practices and procedures that should be considered to help ensure the quality and integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The GEPs address the process of conducting individual epi demiologic studies and do not prescribe specific research methods. Although Guidelines for Good Epidemiology Practices will not guarantee good epidemiology, they will provide a framework within which these issues might be ad dressed. The Guidelines have the following goals: 1. To provide a framework to assist researchers in adhering to good epidemiologic research princi ples. 2. To promote sound epidemiologic research by en couraging quality data collection and analysis. 3. To facilitate the continued development of im proved epidemiologic research methodology. 4. To provide a framework for evaluating epidemio logic studies. 5. To improve the acceptance of studies that use sound scientific methods. 6. To improve the utility of epidemiologic studies in the formulation of public policy. 7. To improve public confidence in epidemiology as a scientific discipline. 8. To facilitate the conservation of technical re sources by promoting careful study design and planning of study conduct. EPA's position that the study itself can be conducted and submitted to EPA in accordance with the GLP standards." The GLPs are directed primarily at experimental laboratory research, often involving the use of animals or cell culture systems. The GLPs address issues that confront researchers conducting experimental toxico logical research. The Guidelines for Good Epidemiology Practices were developed in part to provide an alter native to the GLPs that would appropriately address the issues confronted by epidemiology researchers con ducting nonexperimental studies. Scope ind Application The Guidelines for Good Epidemiology Practices can be applied to all types of occupational and environmental epidemiologic research. Epidemiologic studies often evolve through a number of stages that might include proposals, feasibility studies, and measurement instru ment validation studies that precede the development of a protocol. The GEPs should encompass all activities that begin with protocol development. Clearly, large complex studies will benefit from the careful planning and thorough documentation implicit in these guidelines. Adherence to the spirit of the guide lines will be beneficial for those activities preceding protocol development as well as more informal investi gations such as health hazard assessments/evaluations or small cluster investigations. Even in circumstances of immediate public health concern, the guidelines will provide a useful framework to ensure that all research issues are adequately addressed. Alternative Guidelines A number of other organisations have also become interested in developing or applying guidelines to epi demiologic research.1'1 The Oftloe of Management and Budget (OMB) published "Guidelines for Federal Sta tistical Activities" in which they defined "statistics" as the quantitative results of a survey or study collected for the purposes of reporting population characteris tics.' The Environmental Protection Agency (EPA) re cently modified both the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA) good laboratory practice standards (GLPs) to specifically include epidemiology.41 In re sponse to comments. EPA states that "all studies, in cluding epidemiologic studies . .. [should] be performed under GLP standards. EPA recognises that in such studies data used may not have been generated in conformance with ... GLP standards. However, it is Fufthsr Development of the Guidelines lor GEPs The current document is a first step In developing a framework for improving epidemiologic research prac tices through adherence to sound scientific research principles. The guidelines emphasize data quality and integrity and adequate documentation of research meth ods. These guidelines should evolve based on the expe riences gained through their application to studies. A Special Sote to Headers; As an aid to readers, a glossary of terms is provided In Appendix 2. These definitions reflect the use of the terms in this document. In an effort to be concise and clear, some sections of the guidelines for GEPs include examples and/or further explanation of the issue. Examples or elaborates text appear in italic*. 1222 Guidelines for Good Epidemiology Practicea/The CMA Epidemiology Task Group GENC 005370 Guidelines for Good Epidemiology Practices for Occupational and Environmental Epidemiologic Research I. Organization and Personnel A Organizational Structure The organization or individual conducting the re search shall be fully responsible for the operation and performance of the research. The organization shall be a legal entity with a governing body that sets policy and that is fully responsible for the administrative aspects of the organization and its related research activities. The relationship, roles, and responsibilities of the organizations and/or individuals sponsoring or conduct ing the study should be carefully defined in writing. For example, this should include delineating the roles and responsibilities to be assumed by the study spon sor and the con tractor(s) in communicating various aspects of the study as well as data ownership, ar chiving, etc. 8. Personnel Personnel engaged in epidemiologic research and re lated activities shall have the education, training, and/ or experience necessary to competently perform the assigned functions. The organization shall maintain a current summary of training and experience of these personnel. A job description for each individual engaged in or supervising activities shall be maintained and updated periodically. II. Facilities, Resource Commitment, and Contractors A. Facilities Adequate physical facilities shall be provided to all those engaged in epidemiologic research and related activities. Sufficient resources, eg, office space, relevant equipment, and office/profeasional supplies, shall be available to ensure timely completion of all studies. Suitable storage facilities shall be available to maintain research materials in a aafe and secure environment. B. Resource Commitment Sufficient commitment shall be made at the beginning of each study to ensure its timely and proper completion (see section I1I(L): Protocol). C. Contractors For the purposes of ensuring and documenting the contractor's conformance with the Guidelines for Good Epidemiology Practices, it is recommended that the study sponsor have the right during the course of the study, and for a reasonable period following completion of the study, to inspect the contractor s facilities, in cluding equipment, technical records, and records re lating to the work conducted under the sponsor s con tract. III. Protocol Each study shall have a written protocol. This proto col must be approved before the study begins (see section IV: Review and Approval). The protocol should include the following: A. A descriptive title. B. The names, titles, degrees, addresses, and affili ations of the study director, principal investiga tor. and all co-inveetigators. C. The name(s) and addreas(es) of the sponsor(s). D. An abstract of the protocol. E. The proposed study tasks and milestones, includ ing study approval data (date protocol signed by all signatories), study start date (first date that the protocol is implemented), periodic progress review dates, and completion date. F. A statement of research objectives, specific aims, and rationale. The statement should identify the immediate purpose of the investigation. For example, it might aIso indicate whether the study will be exploratory data analysis, hypothesis testing, or a combination of both as well as whether the proposed study will address previously unan swered Questions, will attempt to corroborate or confirm previous findings, or will be routine epidemiologic surveillance. G. A critical review of the relevant literature to evaluate applicable findings. For example, the literature review should en compass animal and human experiments, clini cal studies, vital statistics, and previous epi demiologic studies. The literature review should be of sufficient depth to identify poten tial confoundera and effect modifiers and to determine areas where new knowledge is needed. H. A description of tbe research methods, including: 1. The overall research design and strategy and reasons for choosing the proposed study de sign. For example, case-control, cohort, cross-sec tional. nested case-control, or other hybrid designs. Journal of Occupational MacMgM^VoiUfna 33 No. 12/Dacambor 1991 1223 GENC 005371 2. The data source* for exposure, health statu*, and risk factors. For example, questionnaires, biological measurement*, exposure/work history rec ord reviews. or exposure/disease registries. 3. Clear definitions of health outcomes, exposure, and other measured risk factors as well as selection criteria, as appropriate, for exposed and nonexposed persona, morbidity or mortal ity cases, and referent groups. 4. Projected study size and. if appropriate, statis tical power. 5. The methods to be used in assembling the study data. This should include a description of, or ref erence to, methods used to control, measure, or reduce various forms of error--eg, bias due to selection, misclassiflcation, inter viewer, or confounding--and its impact on the study. Pretesting procedures for re search instruments and any manuals and formal training to be provided to interview ers, abstractors, coders, or data entry per sonnel should be described or referenced. 6. Procedures for handling the data in the analy sis. This should include a description of proce dures for defining or categorizing exposure and health outcome variables for purposes of analysis. It should also includs provisions for assessing dose-response relationships and treatment of potentially confounding and effect modifying variables. 7. Methods for data analysis. This should include procedures to control, If possible, sources of bias and their influence on results and a description ofplanned com parisons and methods for analyzing and pre senting results. 8. Major limitations of the study design, data sources, and analytic methods. 9. Criteria for interpreting the results. This should include a brief discussion of the characteristics of the proposed study design, including limitations, that will influence the discussion of the results. It also should state criteria for mrmrfnir biological plausibility, internal and external consistency ofthe find ings, and causal inference. Tbs statistical tests to be applied to the data and proce dures for obtaining point estimates and con fidence intervals of measures of occurrence or association should also be described. I. A description of plans for protecting human sub jects. This should include information about whether study subjects will be placed at risk as a result of the study, under what circumstances in formed consent will be required, and provisions for maintaining confidentiaiity of information on study subjects. (See section IV: Review and Approval: section V: Study Conduct: section VI: Communication; and sec tion VII: Archiving.) J. A description of, or reference to, quality assur ance and quality control procedures for all phases of the study. As appropriate, include certification and/or qualifications of any supporting labora tory or research groups (see section VIII: Quality Assurance). K. A description of plans for disseminating and com municating study results (see section VI: Com munication). L. Resources required to conduct the study. Describe, for example, time, personnel, and equipment required to conduct the study, in cluding a brief deecription of the role of each of the personnel assigned to the research project. M. The bibliographic references. N. Addenda, as appropriate. For example, correspondence, collaborative agreements, institutional approvals, and sam ples of ths informed consent forms, question naires, and representative samples ofother doc uments to be used in the study. O. A dated protocol review and approval sign-off shoet for ths study director, principal investiga tor, co-lnvestigators. and all reviewers (see sec tion IV: Review and Approval). P. Dated amendments to ths protocol. IV. Review and Approval Review of study protocols and final reports should encompass all aspects of a study outlined in the Guide lines for Good Epidemiology Practices (see section III: Protocol and section V(D): Study Conduct). All reviews should be conducted in s timely fkshion. It may be appropriate to involve worker or community represent atives in the planning and review of the protocol and study results. A. Scientific Review The study protocol shall receive appropriate scientific review by qualified peraon(s) who are not part of the investigative team to ensure that the study is designed to address the objectives of the research and that the protocol is written according to Guidelinss for Good Epidemiology Practices. The nature and circumstances of this review shall be documented (see section III: Protocol). The scientific aspects of the completed study shall receive appropriate technical review to ensure that the 1224 Guideline* for Good Epidemiology Practice*/The CMA Epidemiology Task Group abstract, summary, and conclusions are supported by the underlying data, methods, and analyses (see section V; Study Conduct). B, Ethical Review The ethical aspects of each study protocol shall be reviewed by an institutional review board or other comparable review procedure. This review should consider- 1. Obligations to research subjects. For example, protecting the welfare of study subjects: the need for. and content of. commu nications and informed consent; protecting pri vacy; and maintaining confidentiality. 2. Obligations to society. For example, avoiding conflicts of interest; avoiding partiality; disseminating the study's findings; data sharing; and pursuing responsi bilities with due diligence. 3. Obligations to funders and employers. For example, specifying obligations in contrac tual form of how research is to be conducted and how it may involve ethical, technical, adminis trative. or legal responsibilities; presenting methods and alternatives; and protecting privi leged information. 4. Obligations to colleagues. For example, promoting and preserving public confidence in epidemiologic research while not over- or underestimating the methods or results of epidemiologic inquiry; reporting methods and results; and disseminating the study's findings. C. Administrative Review The administrative aspects of the study protocol shall receive appropriate review and written approval by sponsors, contractors, and associated third parties to ensure that sufficient resources are available to com* plete the study in a timely and proper fashion. Reports shall include a statement that the study was completed in accordance with the protocol. Including any approved modifications to the protocol, and in ac cordance with the QEPs. Any deviations (Tom the OEPs shall be explained and documented (see section VU: Quality Assurance). V. Study Conduct While the study director shall be responsible for the overall research program, the principal Investigator shall be responsible for the individual research project, including the day-to-day conduct of the study, interpre tation of the study data, and preparation of a final report. These responsibilities extend to all aspects of the study including periodic reporting of study progress as well as quality assurance. In some situations, the study director and the principal investigator may be the same person. To ensure the proper conduct of the study, personnel shall adhere to sound research principles and practices established according to the protocol. A protocol must be approved before the study begins. The study shall be conducted in accordance with the protocol: all deviations from the protocol shall be prop erly documented and authorized by the principal inves tigator. If a decision is made not to complete a research project, the reasons for that decision shall be put in writing, dated, and signed by the responsible party. ie, the individual who makes the decision to terminate the study. A. Protection of Human Subiects Procedures for protecting human subjects shall be followed (see section III(I): Protocol and section IV(B): Review and Approval). Confidential information about study subjects shall be protected using established pro cedures. If stipulated by the study protocol and/or required by an institutional review board, each study subject shall be informed about the purpose of the study and any risks associated with participating in the study. Written consent, if required, shall be obtained from each study subject before he/she participates in the study. Written consent shall include at a minimum: 1. Purpose of the research or study. 2. Name(s), address(es), and phone number(s) of personnel available to answer questions about the research and the rights of study subjects. 3. Expected duration of subject's participation. 4. Eligibility requirements for study participation. 5. Possible benefits to the study subject or others of study results. 6. Statement on the voluntary nature of participation in the study and the right of the study subject to discontinue participation at any time. 7. Statement of confidentiality of records identifying the study subject, including reasonable exceptions to absolute confidentiality, eg, sharing of infor mation with the study subject's personal physician or as required by court order. 8. Description of any foreseeable risks or discomforts to the study subject. 9. Statement of availability of results. 8. Data Collection and Verification All data collected for the study should be recorded directly, accurately, promptly, and legibly. The individ ual^) responsible for the integrity of the data, comput erized and hard copy, shall be identified. Journal of Occupational Medicine/Volume 33 No. 12/Decambar 1991 GENC 005373 All procedure* used to verify end promote the quality and integrity of the data (hall be outlined in writing (tee section VIII: Quality Assurance). An historical file of these procedures shall be maintained, including all revisions and the dates of such revisions. Any changes in data entries shall be documented- C Analysis 14. A statement describing the location where all source data and the final report are stored, (see section VIII: Archiving). 15. A dated study report review sign-off sheet for the study director, principal investigator, co-investi gators. and reviewers and/or auditors (see sec tion IV: Review and Approval and section VIII: Quality Assurance). All data management and statistical analysis pro grams and packages used in the analyses should be documented. AU dated versions used in research shall be kept with accompanying documentation (see section VII: Archiving). D. Study Report Completed studies shall be summarized in a final report that accurately and completely preeenta the study objectives, methods, results, and the principal investigator's interpretation of the findings. The final report shall Include at a minimum: 1. A descriptive title. 2. An abstract. 3. Purpose (objectives) of the research as stated in the protocol. 4. The names, titles, degrees, addressee and affilia tions of the study director, principal investigator, and all co-investigators. 5. Name(s) and addrsss(ss) of sponsor(s). 6. Dates on which the study was initiated and com pleted. 7. Introduction with background, purpose, and spe cific aims of the study. 8. A description of the research methods, including: a. the selection of study subjects and controls, b. the data collection methods used, c. the transformations, calculations, or opera tions on the data, and d. statistical methods ueed in data analyaee. 9. A description of oircumstanoee that may have affected the quality or integrity of the data (see section VIII: Quality Assurance). 10. A summary and analyaee of the data. Include sufficient table*, graphs, and iliustrationa to preeeat the pertinent date and to re flect the analyaee performed. 11. A statement of the conclusions drawn from the analyses of the data. 12. A discussion of the implication of study results. Cite prior research in support ofand in contract to present findings. Discus* possible biases and limitntione in present research. 13. References. VI. Communication Each organization shall predetermine procedures un der which communications of the intent, conduct, re sults. and interpretations of an epidemiologic study will occur, including what function individual! associated with the research must fulfill. These individuals should include the principal investigator, study director, and/ or the sponsor. This procedure may be documented in the form of a company standard operating procedure, in the study protocol, or through contractual agree ment. Government agencies shall be Informed of study re sults in a manner that complies with applicable regula tory requirements. Scientific peers shall be informed of study results by publication in the scientific literature or presentations at scientific eonferencee, workshop#, or symposia, to the extent poeeible. All study subjects shall be informed of the study rseulta and any interpretation of the study findings and conclusions, to the extent poeeible. Study subjects may be informed in person, through meetings, video tapes, letters, newsletters, summary reports, or other appro priate communication. Information about study results shall be provided in language appropriate for the audi ence. VI Archiving There shall be physically secure archives for the orderly storage and expedient retrieval of all study related material. An index shall be prepared to identify the archived contents, to identify their location, and to identify by name and location any materials that by their general nature are not retained in the study archive. Access to the archives shall be controlled and limited to authorised personnel only. Special procedures may be necessary to ensure that access to confidential infor mation is limited and that the confidentiality of infor mation about study subjects is protected (see section m(I): Protocol). At a minimum, the study archive should contain, or refer to, the following: A. Study protocol and copies of all approved modifi cations. B. A final report of the study. 1238 Guidailnas for Good EpidamioJogy Practfcaa/Tha CMA Epidemiology Task Group GENC 005374 C. All source data and. where feasible, specimens, A printed sample of the master computer data file(s) with reference to the location of the machine readable master. If the data include any employee medical rec ords subject to the Access to Employee Medical Records Regulation (29 CFR 1910.20), the rec ords shall be retained according to the provi sions of this rule. D. Documentation adequate to identify and locate all computer programs and statistical procedures used, including version numbers where appropri ate (see section V(C): Study Conduct). E. Copies of computer printouts, including relevant execution code, that form the basis of any tables, graphs, discussions, or interpretations in the final report. Any manually developed calculations shall be documented on a work sheet and similarly retained. F. Correspondence pertaining to the study, standard operating procedures, informed consent releases, copies of all relevant representative material, copies of signed institutional review board and other external reviewer reports, and copies of all quality assurance reports and audits. Include, for example, questionnaires, name, make and model numbers of relevant measure ment instruments, calibration information and procedures. G. Original documents for the following research ma terials shall be included in the archives; 1. Laboratory/research notebooks. 2. Coder modification notebooks. 3. Signed and dated copies of the protocol and final report. research VIII. Quality Assurance Written procedures shall be established to ensure the quality of the data used in a study (see section HI(J): Protocol and section V: Study Conduct). These proce dures shall address data collection and completeness, coding and computer input, storage and retrieval, and data validation and analysis. Any deviations from the GEPs shall be explained and documented in the final report (see section IV(C): Review and Approval). An individual who is net part of the investigative team should be assigned as a study quality assurance auditor. This individual shall, no less than annually, review study compliance with the written quality assur ance procedures. The study quality assurance auditor shall prepare a written summary of the audit. The principal investigator should respond In writing to the audit report, including any remedial actions taken. Quality assurance activities shall address the preced ing sections of these guidelines as well as monitor con formance with established standard operating proce dures (SOPs) (see Appendix 1: Standard Operating Procedures). appendices Appendix l; Standard Operating Procedures Appendix 2: Glossary of Terms Used in the Guidelines for Good Epidemiology Practices Appendix 3: Suggested References on Occupation, Epidemiology Methods Appendix 1 Standard Operating Procedures The Guidelines for Good Epidemiology Practices ad dress the conduct of epidemiologic studies rather than the management of epidemiologic research programs. Many of the suggested guideline requirements can be fulfilled by reference to standard operating procedures for the research program. Standard operating procedures (SOPs) are written, detailed descriptions of routine procedures involved in performing epidemiologic studies. Reproducibility, ac curacy, and validity are ensured when SOPs are de signed to clearly reflect each facility's research proce dures. It should be the responsibility of a designated individual to develop and continuously review and up date SOPs pertaining to his area of responsibility. Sig natures of approval from the department s managing personnel or appropriate designees should be obtained for all new and updated versions. Significant changes in established SOPs should be maintained, including all revisions and the dates of such revisions. The manual of SOPs should be readily available to all research and administrative personnel. Standard operating procedures should include; 1. A statement of the purpoee of the standard operating procedure. 2. A detailed description of the procedure. 3. The person responsible or the training level required to perform the procedure. 4. The date of issue (effective date). 5. The issue number/revision number. 8. Signature of preparer. 7. Authorizing/reviewing signature of manage ment. Examples of research program activities for which SOPs could be established include: 1. Procedures for collecting raw data. 2. Procedures for validating the completeness of the study population. 3. Procedures for coding death certificates. 4. Procedures for assessing error rates in data abstraction and coding. Journal of Occupational Madicina/Voiuma 33 No. 12/Dacambar 1991 1227 5. Security procedures for ensuring the integrity of the raw data and computer records. 6. Procedures for archive management. 7. Procedures for standard industrial hygiene sam pling and analytic methods. 8. Procedures for scientific review. 8. Required composition of scientific review boards. 10. Procedures for data analysis. 11. Procedures for communications. Appendix 2 Glossary of Terms Used in the Guidelines for Good Epidemiology Practices The definitions below reflect the use of theee terms in the Guidelines for Good Epidemiology Practices. These terms may have additional or different meanings in another context. Descriptive Studies--a description of the population under study and the occurrence of disease or disea#related phenomena in populations. The latter may be presented as incidence or prevalence rates according to baaic group characteristics such as age, sex, race, and/ or geographic area.4 Epidemiologic Surveiljanc#--periodic scrutiny of a de fined population using epidemiologic techniques to de tect changee and trends in the distribution of morbidity, mortality, or disease risk factors within that population. Exploratory Data Analysis--analysis of a data set with out a predetermined hypothesis, sometimes referred to as a descriptive study. This can be done with or without tests for statistical significance. Exploratory data analysis can be used to generate hypotheeee, to suggest the most appropriate analytical techniques, to set prior ities for future research, and to help focus subsequent analyses. A study may be a hybrid design and combine both exploratory data analysis sad tssts of ths null hypothesis. Hypothesis Tseting Study--sa analytic study that, through the use of tests of statistical significance, seeks to refute specific predetermined null hypotheeee; the process of answering a specific a priori question or group of questions. A study may be a hybrid design and combine both exploratory data analysis and tsete of the null hypothesis. Legai Entity--legal existence. An entity, other than a natural person, who has sufficient existence in legal contemplation that it can function legally, be sued or sue. and make decisions through agents as in the law of corporations. Hull Hypothec!*--ths study qusetion stated in a null fashion so that it can be tested for statistical signifi cance, eg, tested to determine whether the results might occur by chance alone.7 Principel Investigator ths research invsstigator who has direct responsibility for the initiation, conduct, analysis, and interpretation of a specific study or inves tigation. Qumiity Assurance--the overall program that ensures conformance to established performance standards. The quality assurance process encompasses all aspects of the research operation from the protocol to the final report. Scientific Review---critical evaluation of a scientific study or investigation at any stage of development by peers of ths principal investigator. Standard Operating- Procedure (SOP)--any standard method or process, for conducting or accomplishing a routine research procedure not unique to a specific study. Study--epidemiologic research relating to the distri bution and determinants of health-related outcomes in specified populations and the application of this research to control of health problems. Study Director--the research director, manager, or administrator who is responsible for managing the re search program and who provides oversight of studies or investigations conducted within the research pro gram. Appndix3 Suggested Bibliography on Occupational Epidemiology Methods Breslow N, Day N. Statistical Methods in Cancer Research. Volume 1: The Analytic of Case-Control Stud ioe. Lyon, Prance; 1ARC; I960. Breelow N, Day N. Statistical Methods in Cancer Research. Volume S: The Doaign and Analysis of Cohort Studies. Lyon, Prance: IARC; 1967, Checkoway H, Pearce N, Crawford-Brown D. Research Methoda in Occupational Epidemiology. New York: Ox ford University Press; 1969. Friedman G. Primer of Epidemiology. 3rd ed. New York: McGraw-Hill Book Company; 1967. Kleinbaum D, Kupper L. Morgeastern H. Epidemio logic Reeearch Principle* and Quantitative Methods. Belmont, Calif: Lifetime Learning Publications; 1982. Lilisafeld A, Lilisnfsld D. Foundations of Epidemiol ogy. 2nd sd. New York: Oxford University Press; 1980. Misttinen O. Theoretical Epidemiology: Principlee of Occurrence Reeearching in Medicine. Nsw York: John Wiley 6 Sons, Inc.; 1966. Monson R. Occupational Epidemiology. 2nd sd. Boca Raton, Fla: CSC Prase. Inc.; I960. Rothman K. Modern Epidemiology. Boston: Little Brown 4 Co.; 1966. Schleeaelman J. Case-Control Studies: Design. Con duct, Analysis Nsw York: Oxford University Press; 1968. 1228 GuidoNnot for Good Epidemiology Practicea/Tha CMA Epidemiology Tuk Group fliftftncts 1, IntGrmftncy SUgulRtory Lmon Group: lipidomioioffy Worl Group- Gmdtlines for documentation of epidemiolofic studies. Am J gpide&iol 1981.114609-618, 2 Federsl policy for the protection of human subjecu. F*der*J fofUttr November 10, 1988:63.45660. 3 Office of Management and Budfet. guidelines for federsl ita* tiftjcsi activities, Federsi Ae^zster January 20, 1988:53-1548. 4. Federal Insecticide, Fungicide. vd Rodanticidt Act (FIFRA)ood laboratory prsctlce atandsrda. Fadenl Rtf,,ter Auguat n 1989,84.34062. 5. Toxic Substance* Control Act (TSCA); food laboratory practice itendard*. Federal lUfilter Auguat 17. 1988:84.34034. 6. Friedman G. Primer of Epidemiology 3rd *d. Now York McGraw-Hill Book Company; 1987 7 Lut JM. A Dictionary of Epidemiology. 2nd od. Now York Oxford Unlvorttty Prooo: 1988. Manuscript Reviewers The Editor gratefully acknowledges the valuable contributions of the following individuals who served the Journal of Occupation*! Medicine in the review of manuscripts between October 1. 1990, and September 30, 1991. Thome* J Albin. MA. MS Thomas 3. Armstrong, PhD Mahmoud A. Ayoub. PhD CbsrlM E. Becker MD Avon Blsir. PhD Steven N Blur PED Msrgit Bleecker. MD. PhD Grogory G. Band. PhD. MPH Pearli# Boyd Irvin Brodor. MD Stuart M. Brooks. MD C. Ralph Bunchor. ScD Joaoph M. Cannolla. MD Ralph R. Cook. MD Robart Crapo. MD Roy L. DeHart. MD Elizabeth Dalxall. ScD David C. Deubner. MD Mary V. DiGangi. MD Bortram D. Dlnman. MS Kelly J Donham. DVM Alan M. Ducatman. MD Philip A. Edaiman. MD John Erfurt. BA William Fayarwaatbar. PhD, MPB Robart 0 Faldman. MD Arthur L. Frank. MD, PhD Howard Frumkin. MD David H. Garabrant. MD James 0. Gibb*. PhD Thomas Golaskawaki, EdD Robart A. Gayar. MD Elizabeth E. Graach. MD Raginald M. Griffin. PhD Taa L. Guidotti, MD Nortln M. Hadlar. MD Philip Harbar. MD. MPH Jamea A. Hathaway. MD David Haadartan. MD Gary D. Herrin. PhD C. John Hodgson. MD Richard W. Homing. Dr PH Alan B. Jonaa, PhD Meryl Karol. PhD Bruce W. Karrh, MD W. Monroe Kaysarling, PhD Susan Kinne, PhD Paul Kotin. MD Wayne M. farther. BCD Richard J. Levine. BCD Robert Lewy. BCD Jamas C. Lockay. BCD Wendy D. Lynch, PhD Thomas J. ICarrlott C. G. Toby BCethiss. BCD Metises McDiermid. BCD. MPH Alan A. McLean. BCD W. K. C. Morgan. BCD Lisa Morrow. PhD Royoe Moaar. Jr.. BCD Carolyn NesdJsman. PhD Richard K. Olney, MD Gilbert S. Omenn. MD Sidney Pall. PhD John M. Paten. BID Robart Reger PhD David B. Robbins. BCD Thomas G. Robins. BID Howard E. Rocketts. PhD Linda Roaanstock. BCD Julia Royster. PhD Larry H. Royster. PhD David A- Sarltz. PhD Teresa Schnorr PhD Michael SUvamain. BID Michael Smoianeky. PhD Stover Snook. PhD Kyle Stennlnnd. PhD Nancy Busman. PhD Barbers C. Tilley. PhD Sally W. Vernon, PhD Donald BC. Vickery. BCD Julian A. Waliar. BCD W. Dixon Ward. PhD Konnatb X. Warner. PhD Donald E. Waeeerman. BCSEE. MBA Roberta F. White. PhD Myron L. Wolharsht. PhD C. Craig Wright, MD Journal of Occupati nal Medicine/Volume 33 No. 12/December 1991 1229 6ENC 005377