Document peYdLooG6407Qex0awQMLxoQD

r Guidelines lor Good Epidemiology Practices lor Occupational and Environmental Epidemiologic Research The Chemical Manufacturers Association's Epidemiology Task Group Tbs Guidelines for Oood Epidemiology Practices (GEPs) for Occupational mad Eaviroomoatml Epidemiologic Research addreet the conduct of ttudlee generally undertaken to answer questions about human health in relatiooahip to the workplace or the environment. The QEPe propone minimum praetloee and proeeduree that thould he conaidered to help ensure the quality end integrity of data used in epidemiologic research and to provide adequate documentation of the research methods. The QEPe address the process of conducting individual epidemio logic studies and do not proscribe specific research methods. The Guidelines for Good Epidemiology Practices propane minimum practices and procedures in the following areas: I. Organisation and Personnel II. Facilities, Resource Commitment, and Contractors HI. Protocol TV. Review and Approval V. Study Conduct VI. Communication VII. Archiving VIII, Quality Aasuranoe During the development of the Otildeilnee tss Oood Bptdemtolegy prectlces, tbo following reseerehen wsra memben of CMA's fpjdo miolocy Tut Group: William J. Salley. MPH, Chevron CacporaUaa; Claudio Berner. BS. Xxxea Biomedical Bdeoo**, loo; lames J. Oollioa. PhD. Moneanto Company. Balph B. Cook. HD, MPH. Tho Dow Chessieal Company Barbara J. Divla*. PhD. Tozaoo lam Barry lhthoabaoh. MS. Oraoo Specialty Chomloalo Oompaey: William I. Payarwootkor. PhD. MPH. B. L da Foot do Bemoan aad Go. lao. (fhklrmi* Epidemiology Taak Group): Lomiao Lucas. PhD. tmofiooa Cyaaamid Company: M. Ooraid On. PhD. SASP Oorporatloa: Oarhard K. Baaha, Dr PH. MS. Mobil Corporatios: Bobert Sehnatter, PhD. Kzxoa Momodieal Seiancoa. Inc, Sandra Salanskaa, PhD, Unioa OarMda Chimioali a Plastic* Company Ino: M. Jana Tota, Dr PH. Union ChrMda ChemMal* k piaotiea Company lar. William Thar. MD. liana Blomadiaal Sst*Doo. toe: Sandra L. Tiroy. MS. Chamieal Manuikotaroco dmoBlatloa Addreee oorraopondoaoo to Dr William 1. Fay*1 anther. B. L da Pont do Nemour* and Co. H-11S10-HB. 1007 Markot Street. WUadafton. DE 19MB. aooaiTM/ti/Mia-imiaaa.oo/o Cooynpht C by Aaenaas Cell*** el Oooopotioail Means* Although tbo Ouidollnoo for Oood Epidemiology Practice* will not guarantee good epidemiology, they do provide a uneful framework for ensuring thnt all raaoarch iaauaa are adequately addraaaad. This framework is proponed as n first stop in improving apidomiologic research praeticaa through adhoraneo to sound acisntific raaoarch principlaa. Appandleaa provida an overview of standard op*rating proooduraa. a gloaaary of terms used In tbo Ouidslins*. and suggaatad rafsronoaa on oooupational epidemiology mothods. Epidomiologic studio* provida unique, valuabl* infor mation about the relationship between human health aad expoeur* to subetancee in the environment and the workplace. While the contributions of toxicology aad epidemiology are complementary, there is general agreement that reliable human evidence (epidemiologic etudiee) should take precedence over animal data (tox icological studiee) in public policy aad regulatory deci sion making. However, because of the noaexperimental nature of oooupational aad environmental epidemiologic etudiee, scientific controversy often surround* the inter pretation and significance of epidemiologic study re sults. la addition, controversy frequently concerns the quality of the data used, the appropriateness of the study design, end the process used to conduct the study. The nonexperimentel nature of the epidemiologic stud ies nannot bo changed, but the value of such research can be improved. The Guidelines for Good Epidemiology Practices sddrem those issues--data quality, study de sign, and study oonduct--that are under the ooutrol of tho Investigator. Goals tor At GuMaftwe lor Good Epidemiology Pfiettcee The Guidelines for Good Epidemiology Practices (GEPa) address the oonduct of studies generally under 90k Joumel of Occupational Madicina/Voiuma 33 No. 12/Dacambar 1991 1221 GENC 00526 taken to answer queetion* about human haalth in relationahip to tha workplaca or the environment. The QEPa propoaa minimum practices and procedure* that ahouid be conaidered to help enaure the quality and integrity of data uaed in epidemiologic reaearch and to provide adequate documentation of the reaearch method*. The OEP* addreaa the proceaa of conducting individual epi demiologic itudie* and do not preacribe apeciflc reaearch method*. Although Guideline* for Good Epidemiology Practice* will not guarantee good epidemiology, they will provide a framework within which thee# iaauee might be addreeaed. The Guideline* have the following goal*: 1. To provide a framework to aaeiat researcher* in adhering to good epidemiologic reaearch princi ple*. 2. To promote eound epidemiologic reaearch by en couraging quality data collection and analyaia. 3. To facilitate the continued development of im proved epidemiologic research methodology. 4. To provide a framework for evaluating epidemio logic etudies. 6. 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 aa a scientific discipline. 8. To facilitate the conservation of technical re sources by promoting careful study design and planning of study conduct. EPA* position that the study itself can be conducted and submitted to EPA in accordance with the GLP standards." The GLP* are directed primarily at experiments laboratory research, often involving the use of animals or cell culture systems. The GLP* 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 GLP* that would appropriately addreaa the issues confronted by epidemiology researcher* con ducting nonexperimental studies. Scope sod 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 deveiopmont. 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 aa well as more informal invss gationi such as health hazard asseeaments/evaluatio or small cluster investigations. Even in circumstance* of immediate public health ooncern, the guidelines will provide a useful framework to ensure that all research issues are adequately addressed. Aftamitiva Guideline* A number of other organisations have also beoome interested in developing or applying guidelines to epi demiologic research.1'* The Offiee of Management and Budget (OMB) published "Guidelines for Federal Sta tistical Activities" in which they defined "statistics" aa the quantitative results of a survey or study collected for the purposes of reporting population characteris tic*.* The Environmental Protection Agency (SPA) re cently modified both the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA) good laboratory practice standards (GLP*) to specifically include epidemiology.44 In re sponse to comments, EPA states that "all studies, in cluding epidemiologic studies ... [should] be performed under GLP standards. EPA recognise* that in such studies data uaed may net have been generated In conformance with ... GLP standards. However, it is Further Development of Km Guideflnes for GBPe The current document is a first step in developing a framework for improving epidemiologic research prac tices through adherence to sound scisntific research principles. The guidelines emphasize data quality and integrity and adequate documentation of research meth ods. Thane guidelines should evolve based on the expe riences gained through their application to studies. A Special Mott to Headers; As an aid to readers, a glossary of terms la provided in Appendix 2. These definitions refleot tha use of tha terms in this document. In an effort to be concise and dear, some sections of the guidelines for GEPs indude examples and/or further explanation of the issue. Examples or slaborativs text appear in itmUeo. 1222 Quldoflnot for Good Epidemiology Pmctteoe/Tho CMA Epidemiology T$k Guideline* for Good Epidemiology Practice* for Occupational and Environmental Epidemiologic Research L 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 rales tad responsibilities to he assumed by the study spon sor aad the controctor(s) in communicating various aspects of tbs study as wall as data ownership, ar chiving. ate. B. 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 bo maintained and updated periodically. V. 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 offioe/profeeaional supplies, shall be available to ensure timely completion of all studio*. Suitable storage facilities shall be available to maintain research materials in a safe 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 Ill(L): Protocol). C. Contractors For the purposes of ensuring and documenting the contractor's conformance with the Guidelines for Good Epidemiology Practice*. 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, technics^ records, and records re lating to the work conducted under the sponsor's con tract. M f^e*t a ti He rlWwwW 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-investigators. C. The name(s) and address(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. 77># statement should identify the immediate purpose of the investigation. For example, it might also 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 oonllrm previous findings, or will be routine epidemiologic surveillanoe. G. A critical review of the relevant literature to evaluate applicable findings. For example, the literature review should en compass animal and human experiments, elinioal studies, vital statistics, and previous epidsmioJogie studies. The literature review should be of sufficient depth to identify poten tial oanlbundert and effect modifiers and to determine areas where new knowledge is H. A description of the research methods, including: 1. The overall research design and strategy and reasons for choosing tbs proposed study de sign. For example, eaae-oontrol. cohort, cross-sec tional, nested case control, or other hybrid designs. Journal of Occupational MatfkftMfYohiina 33 No. 12/D#ca<nb*r 1931 1223 9. The data source# for exposure, health status, and risk factor*. for example, questionnaires, biological measurements, exposure/ work history rec ord reviews, or exposure/disease registries. 3. Clear definition* of health outcome#, exposure, and other meaeured risk factors ae veil ae 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. 6. 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, misclassiOoatlon, 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 categorising exposure and health outcome variables tor purposes of analysis. It should also include provisions for assessing dose-response relationships and treatment of potentially oonfounding and effect modifying variables. 7. Methods for data analysis. This should include procedures to oontrol, if possible, sources of Idas and their influence on results and a description of planned com parisons and methods fbr analysing 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 tbs results. It also should state criteria fbr assessing biological plausibility, internal and external consistency ofthe find ings, and causal inference. The statistical tests to be applied to the data and proce dures fbr obtaining point estimates and con fidence intervale of measures of oeourrenoe or association should also be described. I. A description of plans tor protecting human sub jects. This should Include informstion shout whether study subjects will be pieced at risk as a result of the study, under what circumstances in formed consent will be required, and previsions fbr maintaining confidentiality of information on study subjects. (See eection IV: Review and Approval: section Study Conduct; section VI: Communication; and sec tion VII: Archiving.) J. A deecription of, or reference to, quality aeeurance and quality control procedures for all phases of the etudy. As appropriate, include certification and/or qualifications of any supporting labora tory or research groups (see eection VLL1: Quality Assuranoe). K. A deecription of plans for disseminating and com municating study results (see section VI: Com munication). L. Resources required to oonduct the study. Describe, fbr example, time, personnel, and equipment required to oonduct the study, in cluding a brief deecription of the role of each of the personnel assigned to tbs research project. M. The bibliographic references. N. Addenda, as appropriate. For example, correspondence, ooUsborative agreements, institutional approvals, and sam ples of tha informed consent forms, question naires, and representative samplsa ofother doc uments to be used in the study. O. A dated protocol review and approval sign-off sheet for the study director, principal investiga tor, oo-investigators, and all reviewers (see ms tion IV: Review and Approval). P. Dated amendments to the protocol. W RI1auMIaVhi M^^a^ AIfsJJuJNmJiVbMI Review of study protocols and final reports should encompass all aspects of a study outlined In the Guide lines tor Good Epidemiology Practices (see section HI: Protocol and section V(D): Study Conduct). All reviews should be conducted in a timely fashion. It may be appropriate to Involve worker or oommunity representativee in the planning and review of the protocol and etudy results. A SarntMc Review The study protocol shall receive appropriate scientific review by qualified pereon(s) who are not part of the Investigative team to ensure that the study is designed to sddress the objectives of the research and that the protoool Is written according to Guidelines tor Good Epidemiology Practices. The nature and circumstances of this review shall be documented (see section ID: Protoool). The scientific aspects of the completed study shall receive appropriate technical review to ensure that the 1224 OuidgfinM for Good Epidemiology Practical/Th# CMA Epidemiology Task GENC 005272 r ibttrftct, summary, and conclusion* are supported by tba underlying data, method*, and analyses (see section V: Study Conduct). 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. 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 exempie, protecting the welfere of study subjects; the need for, end content of, commu nications end informed consent; protecting pri vacy; and maintaining confldentislity. 8. Obligations to society. 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. For exempie, a voiding conflicts of internet; evoiding pertielity: dieeemlneting the etudy'e A. Protection of Human Subjects findings; dote shmring; end pursuing responsi bilities with due diligence. 3. Obligations to funders and employers. Procedures for protecting human subjects shall be followed (see section 111(1): Protocol and section IV(B): Review and Approval). Confidential information about For exempie, specifying obiigetions in contrac study subjects shall be protected using established pro tual form ofhow reseerch into be conducted end cedures. how it mey involve ethica/, technicel, edmlnis- If stipulated by the study protocol and/or required by tretive, or legel responsibilities: presenting an institutional review board, each study subject shall methods and alternatives; and protecting privi be informed about the purpose of the study and any leged informetion. risks associated with participating in the study. Written r 4. Obligations to colleagues. oonsent. if required, shall be obtained from each study For exempie, promoting and preserving public confidence in epidemiologic reseerch while not subject before he/sbe participates in the study. Written consent shall include at a minimum: over- or underestimsting the methods or results 1. Purpose of the research or study. of epidemiologic inquiry: reporting methods end 8. Name(s), address(ee), and phone number(s) of results; end dissemineting the study 's findings. personnel available to answer questions about the research and the rights of study subjects. C. Administrative Review 8. Expected duration of subject's participation. 4. Eligibility requirements tor study participation. The administrative aspects of the study protocol shall receive appropriate review and written approval by sponsors, contractors, and associated third parties to 6. Possible benefits to the study subject or others of study results. 6. Statement on the voluntary nature of participation ensure that sufficient resource* are available to com plete the study in a timely and proper thshion. in the study and the right of the study subject to discontinue participation at any time. Reports shall include a statement that the study was 7. Statement of confidentiality of records Identifying completed in accordance with the protocol, including the study subject, including reasonable exceptions any approved modifications to the protocol, and In ac to absolute confidentiality, eg, sharing of infor cordance with the QEP*. Any deviations from the OKPs mation with the study subject's personal physician shall be explained and documented (see section VIII: or as required by oourt order. Quality Assurance). e 5. Description of any foreseeable risks or discomforts to the study subject. 1 V. Study Conduct 9. Statement of availability of results. i While the study director shall be responsible for the . mb uaacnon vn vemcnon overall research program, the principal investigator shall be responsible for the individual research project. All data oollectad tor the study should be recorded Including the day-to-day conduct of the study, interpre directly, accurately, promptly, and legibly. The individ U tation of the study data, and preparation of a final uals) responsible for the Integrity of the data, comput report. These responsibilities extend to all aspects of erized and hard copy, shall be identified. P Journal of Occupational Madicina/Vohwna 33 No. 12/Dacambar 1991 1225 GENIC 005273 All procedure uMd to verify aad proraoto tho quality and integrity of tho data shall bo outlinod la writing (mo ooctioa VUI: Quality Assurance). Aa historical file of thoM procedure# shall bo aaiataiaod, iacludlnf all revisions aad tho datM of such revisions. Any changes la data sntrios shall bo documented. C. Analysis 14. A statomoat describing tho location whore all source data and tho final report are stored, (see section VUI: Archiving). 18. A dated study report review sign-off sheet for the study director, principal investigator, eo-investi gators, and reviewers and/or auditors (see sec tion IV: Beview and Approval and section VUI: Quality Assurance). All data management and statistical analysis pro grams and packages used in the analysoo should be documented. All dated versions used in research shall be kept with accompanying documentation (see section VH: Archiving). D. Study Report Completed studies shall bo summarised in a final report that accurately and completely preeents the study objectives, methods, results, aad the principal investigator's interpretation of the findings. The final report shall include at a minimum: 1. A descriptive title. S. Aa 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 address(os) of sponeor(s). 6. Dates on which tho study was initiated and com pleted. 7. Introduction with background, purpose, and spa cifle alma of the study. VL Communication Each organisation shall predetermine procedures un der which communications of the intent, conduct, re sults. and interpretations of an epidemiologic study will occur, including what function individuals associated with the research must fulfill. These individuals should include the principal investigator, study director, and/ or the sponsor. This procedure may ha 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 compliao with applicable regula tory requirements. Scientific peers shall be informed of study results by publication in the scientific literature or presentations at scientific oonferenoee. workshops, or symposia, to the extent possible. All study subjects shall be informed of the study results and any Interpretation of the study findings aad ooneiusiona, to the extent possible. Study subjects mMtfk be Informed in person, through meetings, video tape^^ letters, newsletters, summary reports, or other appro priate communication. Information about study results hall be provided in language appropriate for the audi ence. 8. A description of the research methods, including: a. the Mlection of study subjects and controls, b. the data collection methods used, c. the transformations, calculations, or opera tions on the data, aad d. statistical methods used in data analyses 9. A description of circumstances that may have affected the quality or integrity of the data (see section VIII: Quality Assuranoe). 10. A summary and snslysss of the data. Include sufllefent tables, graphs; and illustra tions to present the pertinent dete and to re flect the ens(yss> performed. 11. A statement of the conclusions drawn from the analyses of the data. 18. A discussion of the implication of study results. C/to prior research in support ofand in contrast to proooat Hading*. Discuss possible hisses sad limitationa la proooat research. V*. ArdMng Thera aball be physically secure archives for the orderly storage aad expedient retrieval of all study related material. An index shall be prepared to identify the archived oontente, to Identify their location, and to identity by name and location any materials that by their general nature are not retained in the study archive. Aooees to tho arohivee shall bo controlled and limited to authorlaad personnel only. Special procedures may be neoeeeary to ensure that aecees to confidential Infor mation in aad that the confidentiality of infor mation about study subjects is protected (see section IH(I): Protocol). At a tho study archive should contain, or refer to, tho following: A. Study protoool and oopiea of all approved modifi cations. 13. References. B. A final report of the study. 1238 M Quidofinoa lor Qood Epidemiology Practice*/!*# CMA Epidemiology Task G GENC 005274 C. All source date and, where feasible, epecimeas. A printed sample of the master computer data flle(s) with reference to the location of the machine readable master. If the date include may employee medical rec ords subject to the Access to Employee Medical Records Regulation (89 CFR 1910.80), 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, cop ies 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. 8. Coder modification notebooks. 3. Signed and dated copies of the protocol and final report. research m Quality Assurance Written procedures shall be established to ensure the quality of the data used in a study (see section m(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 not part of the Investigative team should be assigned as a study quality assurance auditor. This individual shall, no lees then annually, review study compliance with the written quality assur ance procedures. The study quality sasuranoe auditor shall prepare a written summary of the audit. The principal investigator should respond in writing to the audit report, including any remedial notions taken. Quality assurance activities shall address the preced ing sections of these guidelines as well as monitor oonforaance with established standard operating proce dures (SOP*) (see Appendix l: Standard Operating Procedures). APPENOICES Appendix 1: Standard Operating Procedures Appendix 8: Glossary of Terms Used In the Guidelines for Good Epidemiology Practices Appendix 3: Suggested References on Occupation. Epidemiology Methods Appendix 1 Standard Operatng 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 datss of such revisions. The manual of SOPs should bo readily available to all research and administrative personnel. Standard operating procedures should include: 1. A statement of the purpose of the standard operating procedure. 8. A detailed description of the procedure. 8. 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. 6. Signature of preparer. 7. Authorising/reviewing signature of manage ment. Exampise of research program activities for which SOPs oould be established include: 1. Procedures for collecting raw data. 8. Procedures for validating the completeness of the study population. 8. Procedures for coding death certificates. 4. Procedures for assessing error rates in date abstraction and ooding. Journal f Occupational Medicine/Volume 33 No. 12/December 1M1 1227 6. Security procedure* for ensuring the integrity of the rev date and computer records. 6. Procedures for archive management. 7. Procedures for standard industrial hygiene sam pling and analytic methods. 8. Procedure* for scientific review. 9. Required composition of scientific review boards. 10. Procedures for data analysis. 11. Procedures for communications. <tppendix2 Glossary of Tetms Used in the Guidelines for Good Epidemiology Practices Ths definitions below reflect the use of theee terms in th* Guideline# for Good Epidemiology Practices. These terms may have additional or different meaning* in snothsr context. Doocriptire Studies--s description of the population under study and the occurrence of diseas* or dieesse related phenomena in populations. Th* latter may be presented as incidence or prevalence rates according to basic group characteristics such sa ags, sex, race, and/ or geographic area.* Epidemiologic fiorveii/anoe--periodic scrutiny of a de fined population using epidemiologic technique* to de tect changes end trends in th* distribution of morbidity, mortality, or disease risk factor* within that population. Exploratory Dota Aaalyaia--analysis of a data sat with out s predetermined hypothesis, sometimes referred to sa s descriptive study. This can b* don* with or without taste for statistical significance. Exploratory data analysis can be used to generate hypotheses, to suggest th* most appropriate analytical techniques, to set prior ities for future research, and to help focus subsequent analyses. A study may be a hybrid design end oombine both exploratory data analysis and taste of ths null hypothesis. Hypothesis Tooting Study--an analytic study that, through ths use of teste of statistical significance, seeks to refute specific predetermined null hypotheses; ths 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 tests of tbs Bull hypothesis. Logoi 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. Null Hypothesis--ths study question stated in a null fashion so that it can bo tested for statistical signifi cance. eg. tested to determine whether the rooults might occur by chance alone.7 Principal Investigator--the research investigator who has direct responsibility for the initiation, conduct, analysis, and interpretation of a specific study or invest tigstion. | Quality Assurance--tbs overall program that ensures conformance to established performance standards. The quality assurance process encompass** all aspects of the research operation from the protocol to the final report. Scientific RsWew--critical evaluation of a scientific study or Investigation at any stags 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 pacified populations and the application of this research to control of health problema. 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. AppandteS Suggested Bfeiognphy on Occupational Epideniciogy Methods Breelov N, Day N. Statistical Mathoda in Cone Research. Volume 1: The Anolyoia of Coaa-Control StudIda. Lyon, Prance; IARC; I960. Breelow N, Day N. Statistical Mathoda in Cancer Rooearch. Volume S; The Daaign and Analytia of Cohort Studied. Lyon, France: IARC; 1967. Checkoway H, Pearce N. Crawford-Brown D. Research Mathoda in Occupational Epidamiology. Mew York: Ox ford University Freer. 1969. Friedman G. Primer of Epldomiology. 3rd ed. New York: MoGraw-Hill Book Company, 1967. Klelnbeum D, Supper L, Morgenstern H. Epidemio logic Research Prinoipleo and Quantitative Mathoda. Belmont, Calif. Lifetime learning Publications; 1968. Lilienfeld A, Lillenfeld D. Foundations of Epidemiol ogy. Sad ed. Mew York: Oxford University Press; 1960. Mietttasa 0. Theoretical Epidemiology: Principled of Occurrence Researching in Medicine. Mew York: John WUey * Bona. Inc.; 1966. Moaaon B. Occupational Epidemiology. Sad ed. Boca Eatoa. Fla: CBC Prase, Inc.; I960. W/itKmm K_ Modern Epidemiology. Boston: Little Brown 4 Co.; 1906. Schleeselman J. Coao Control Studloa: Daaign. Conduet, Aaalyaia. Mew York: Oxford University Press: 1668. 1228 Guidefine* for Good Epidemiology Practicee/The CMA Epidemiology Task 6EHC 005276 1. Interagency Regulatory Liaison Group; Epidemiology Work group. Guideline* for documentation of epidemiologic studies. Am J jpidomioi. 19*1:114:809-611. g. Federal policy for tho protection of human subject*. Federal gtgigur November 10. 1986:53:46660. 3. Office of Management and Budget: guideiinee for federal atatieticai activitiee Federal Register. January 90. 1966:53:1649. 4- Federal tneacticide. Fungicide, and Bodenticide Act (PIPRa); food laboratory practice etandard*. Federal Register August 17. 19*9:34:34069 9. Tonic Subetancee Control Act (TBCA); good laboratory practice ttandards. Federal Register. August 17. 19*9:34 34034. 8- Friedman 0. Frimer at EpUamtoiagf. 3rd ed. New York: McGraw-Hill Book Company; 19*7. 7. Last JM. A Dictionary of Epidemiology Bad ed. New York: Oxford University Frees: 19**. Manuscript Reviewers The Editor freteftilly acknowledge* the valuable contributions of the following individual* who nerved the Journal of Occupational Madicina in the review of manuscripts between October 1. 1990. nnd September 30, 1991. Thome* J. Alhm. MA. MS Themes J Armstrong. PhD Mnhmoud A. Ayouh. FhD Charlee E. Becker. MD Aaron Blair. FhD Steven N Blair. FED Margit Bleacher. MD. PhD Gregory 0. Bond. PhD. MPH Pearli* Boyd Irvin Broder. MD Stuart M. Brooks. MD C. Ralph Buncher. ScD Joseph M. Cannetla. MD Balph R. Cook. MD Robert Crapo. MD Boy L. DeHart. MD Elisabeth Delisll. ScD David C. Deubner. MS Mary V. DiOangt. MD Bertram D. Dinman. MD Kelly J. Donham. DVM Alan M. Ducatman. MD Philip A. Edelman. MD John ErfUrt. BA William Fayerwaathar. PhD. MPH Robert 0. Feldman. MD Arthur U Frank. MD. FhD Howard Frumkin. MD David H. Onrahrnot. MD Jams* O Oitaha. PhD Thomaa Qolaeeawuki. EdD Robert A. Ooyer. MD Elisabeth E. Oreech. MD Reginald M. Griffin. PhD Tee L. Guidotti. MD Nortin M. Hadlar. MD Philip Harder. MD, MPH James A. Hathaway. MD David Handenon. MD Gary D. Herrin. PhD C. John Hodgson. MD Richard W. Homing. Dr PH Alnn 1. Jooe*. PhD Meryl Enrol, PhD Bruo* W. Karrh. MD W. Monro* Keyeeriing, PhD Susan Kins*. PhD Paul Kotin. MD Wayne M. Ladner MD Richard 1. Levine. MD Robert Lewy. MD Jamee E. Imotay. MD Wendy D. Lyaofc. PhD Thomna J Marriott C. 0. Toby Mntblne MD Melissa McDiannid. MD, MPH Alan A. McLean. MD w. E, C. Morgan. MD Lie* Marrow. PhD Royoe Menu. Jr.. MD Carolyn Needletnen, PhD Richard K. Olnay, MD Gilbert S. Omenn. MD Sidney Pell. PhD John M. Fetor*. MD Robert Reger. PhD David B. Robbine. MD Thomas G. Bobina. MD Howard R. Rocketts. PhD Linda Bneensteek, MD Julia Royster. PhD Larry H. Royster. PhD David A. Savitt, PhD Teresa Sobnorr. PhD Miobael Silvereteia. MD Michael Bomlenefey, PhD Stover Snook. PhD Kyla Stennland. PhD Haaoy tiusmaa. PhD Barbara C. TUley. PhD Sally W. Vernon. PhD Donald M Vickery. MD Julian A. Waller. MD W. Dixon Ward, PhD Kannetb E. Warner. PhD Donnld E. Weeeermnn. MSEE. MBA Roberta P. White. PhD Myron L. Wolbarmbt. PhD C. Craig Wright. MD Journal of Occupati nal Madieina/Voluma 33 No. 12/Dacambar 1991 1229 GENC 005277