I. Organization and Personnel
A. Organizational Structure
The organization or individual conducting the research 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 adminstrative
aspects of the organization and its related research activities.
The relationship, roles and responsibilities of the organizations and/or individuals
sponsoring or conducting the study should be carefully defind in writing.
For example, this should include delinating the roles and responsibilites to be
assumed by the study sponsor and the contractor(s) in communicating various aspects of the
study as well as data ownership, archiving etc.
Personnel engaged in epidemiologic research and related 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
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/professional supplies, shall be available to ensure timely
completion of all studies. 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 III-K protocol).
For the purposes of ensuring and documenting the contractor`s conformance with the
guidelines of 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
completiong of the study, to inspect the contractor`s facilities, including equipment,
technical records, and records relating to the work conducted under the sponsor`s
Each study shall have a written protocol. This protocol must be approved before study
begins (see section IV: Review and Approval).
The protocol should include the following:
- A Descriptive title.
- The names, titles, degrees, addresses, and affiliations of the study director, principal
investigator, and all co-investigators.
- The name(s) and address(es) of the sponsor(s).
- An abstract of the protocol.
- The proposed study tasks and milestones, including study approval data (data protocol
signed by all signatories), study start date (first date that the protocol is
implemented), periodic progress review dates, and completion date.
- A statement of research objectives, specific aims, and rationale:
The 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 unanswered questions, will attempt to corroborate or confirm previous findings,
or will be routine epidemiologic surveillance.
- A critical review of the relevant literature to evaluate applicable findings.
For example, the literature review should encompass animal and human experiments,
clinical studies, vital statistics, and previous epidemiologic studies. The literature
review should be of sufficient depth to identify potential cofounders and effect modifiers
and to determine areas where new knowledge is needed.
- A description of the research methods, including:
1. The overall research design and strategy and reasons for choosing the proposed study
For example, case control, cohort, cross-sectional, nested case control or other
2. The data sources for exposure, health status, and risk factors.
For example, questionnaries, biological measurements, exposure/work history record
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 persons, morbidity
or mortality cases, and referent groups.
4. Projected study size, and if appropriate, statistical power.
5. The methods to be used in assembling the study data.
This should include a description of, or reference to, methods used to control,
measure, or reduce various forms of error - eg, bias due to selection, misclassification,
interviewer, or confounding - and its impact on the study. Pretesting procedures for
research instruments and any manuals and formal training to be provided to interviewers,
abstractors, coders, or data entry personnel should be described or referenced.
6. Procedures for handling the data in the analysis.
This should include a description of procedures for defining or categorizing exposure
and health outcome variables for purposes of analysis. It should also include 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 of planned comparisons and methods for analyzing
and presenting 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 assessing biological plausibility, internal and external
consistency of the findings, and casual inference. The statistical tests to be applied to
the data and procedures for obtaining point estimates and condience intervals of measures
of occurence or association should also be described.
- A description of plan for protecting human subjects.
This should include information about whether study subjects will be placed at risk as
a result of the study, under what circumstances informed consent will be required, and
provisions for maintaing confidentiality of information on study subjects. (See
section IV: Review and Approval; section V: Study Conduct; section VI: Communication; and
section VII: Archiving)
- A description of, or reference to, quality assurance and quality control procedures for
all phases of the study. As appropriate, include certification and/or qualifications of
any supporting laboratory or research groups (see section VIII: Quality Assurance).
- A description of plans for disseminating and communicating study results (see section
- Resources required to conduct the study.
Describe, for example, time, personnel, and equipment required to conduct the study,
including a brief description of the role of each of the personnel assigned to the
- The bibliographic references.
- Addenda, as appropriate.
For example, correspondence, collaborative agreements, institutional approvals, and
samples of the informed consent forms, questionnaries, and representative sampes of other
documents to be used in the study.
- A dated protocol review and approval sign-off sheet for the study director, principal
investigator, co-investigators, and all reviewers (see section IV: Review and Approval).
- Dated amendments to the protocol.
IV. Review and Approval
Review of study protocols and final reports should encompass all aspects of a study
outlined in the guidelines for Good Epidemiology Practices (see section III: Protocol and
section V-D: Study Conduct). All reviews shoud be conducted in a timely fashion. It may be
appropriate to involve worker or community representatives in the planning and review of
the protocol and study results.
A. Scientific Review
The study protocol shall receive appropriate scientific review by qualified person(s)
who are not part of the investigative team to ensure that the study is designed to address
that objectives of the research and that the protocol is written according to Guidelines
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 abstract, summary and conclusions are supported by the
underlying data, methods, and analysis (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:
- Obligations to research subjects.
For example, protecting the welfare of study subjects; the need for, and content or,
communications and informed consent; protecting privacy; and maintaining
- Obligations to society.
For example, avoiding conflicts of interest; avoiding partiality; disseminating the
study`s findings; data sharing; and pursuing responsibilities with due diligence.
- Obligations to funders and employers.
For example, specifying obligations in contractual form of how research is to be
conducted and how it may involve ethical, technical, adminstrative, or legal
responsibilities; presenting methods and alternatives; and protecting privileged
- Obligations to colleagures.
For example, promoting and preserving public confidence in epidemiologic research
while not over or underestimating the methods or results or epidemiologic inquiry;
reporting methods and results; and disseminating the study`s findings.
C. Administrative Review
The adminstrative 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 complete 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 accordance with the
GEPs. Any deviations from the GEPs shall be explained and documented (see section VIII:
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, interpretation 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 properly
documented and authorized by the principal investigator.
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 Subjects
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 procedures.
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 participate in the study.
Written consent shall include at a minimum:
- Purpose of the research or study.
- Name(s), address(es), and phone number(s) of personnel available to answer questions
about the research and the rights of study subjects.
- Expected duration of subject`s participation.
- Eligibility requirements for study participation.
- Possible benefits to the study subject or other of study results.
- Statement on the voluntary nature of participation in the study and the right of the
study subject to discontinue participation at any time.
- Statement of confidentiality of records identifying the study subject, including
reasonable exceptions to absolute confidentiality, eg, sharing of information with the
study subject`s personal physician or as required by court order.
- Description of any foreseeable risks or discomforts to the study subject.
- Statement of availability of results.
B. Data Collection and Verification
All data collected for the study should be recorded directly, accurately, promptly, and
legibly. The individual(s) responsible for the integrity of the data, computerized and
hard copy, shall be identified.
All procedures used to verify and promot the quality and integrity of the data shall be
outlined in writing (see 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 the data enteries shall be documented.
All data management and statistical analysis programs and packages used in the analysis
should be documented. All 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
presents the study objectives, methods, results and the principal investigator`s
interpretation of the findings.
The final report shall include at a minimum:
- A descriptive title.
- An abstract.
- Purpose (objectives) of the research as stated in the protocol.
- The names, titles, degrees, addresses and affiliations of the study director, principal
investigator, and all co-investigators.
- Name(s) and address(es) of sponsor(s).
- Dates on which the study was initiated and completed.
- Introduction with background, purposed, and specific aims of the study.
- 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 operations of the data, and
d. statistical methods used in data analyses.
- A description of circumstances that may have affected the quality or integrity of the
data (see section VIII: Quality Assurance).
- A summar and analyses of the data.
Include sufficient tables, graphs, and illustrations to present the pertinent data and
to reflect the analyses performed.
- A statement of the conclusions drawn from the analyses of the data.
- A discussion of the implication of study results.
Cite prior research in support of an in contrast to present findings. Discuss possible
biases and limitations in present research.
- A statement describing the location where all source data and the final report stored
(see section VIII: Archiving).
- A dated study review sign-ff sheet for the study director, principal investigator,
co-investigators, and reviewers and/or auditors (see section IV: Review and Approval and
section VIII: Quality Assurance).
Each organization shall predetermine procedures under which communications of the
intent, conduct, results, 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 be documented in the form of a company standard operating procedure, in
the study protocol, or through contractual agreement.
Government agencies shall be informed of study results in a manner that complies with
applicable regulatory requirements.
Scientific peers shall be informed of study results by publication in the scientific
literature or presentations at scientific conferences, workshops, or symposia, to the
All study subjects shall be informed of the study results and any interpretation of the
study findings and conclusions, to the extent possible. Study subjects may be informed in
person, through meetings, video tapes, letters, newsletters, summary reports, or other
appropriate communcation. Information about study results shall be provided in language
appropriate for the audience.
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
material that by their general nature or not retained in the study archive.
Access to the archives shall be controlled and limited to authorized personnel only.
Special procedures may be necessary to ensure that access to confidential information is
limited and that the confidentiality of information about study subjects is protected (see
section III-I: Protocol).
At a minimum the study archive should contain, or refer to, the following:
- Study protocol and copies of all approved modifications.
- A final report of the study.
- 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.
- Documentation adequate to identify and locate all computer programs and statistical
procedures used, including version numbers where appropriate (see section V-C: Study
- 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.
- 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
measurement instruments, calibration information and procedures.
- Original documents for the following research materials shall be included in the
1. Laboratory / research notebooks.
2. Coder modification notebooks.
3. Signed and dated copies of the research protocol and final report.
VIII. Quality Assurance
Written procedures shall be established to ensure the quality of the data used in a
study (see section III-J: Protocol and section V: Study Conduct). These procedures shall
addres 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 less than annually, review study
compliance with the written quality assurance 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 preceeding sections of these guidelines
as well as monitor conformance with established standard operating procedures (SOPs) (see
Appendix 1: Standing Operating Procedures).
Standard Operating procedures
The Guidelines for Good Epidemiology Practices address 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, accuracy, and
validity are ensured when SOPs are designed to clearly reflect each facility`s research
procedures. It should be the responsibility of a designated individual to develop and
continuously review and update SOPs pertaining to his area of responsibility. Signatures
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 dates of such revisions. The manual of SOPs
should be readily available to all research and administrative personnel.
- A statement of the purpose of the standard operating procedure.
- A detailed description of the procedure.
- The person responsible or the training level required to perform the procedure.
- The date of issue (effective date).
- The issue number / revision number.
- Sigature or preparer.
- Authorizing / reviewing signature of management.
Examples of research program activities for which SOPs could be established include:
- Procedures for collecting raw data.
- Procedures for validating the completeness of the study population.
- Procedures for coding death certificates.
- Procedures for assessing error rates in data abstraction and coding.
- Security procedures for ensuring the integrity of the raw data and computer records.
- Procedures for archive management.
- Procedurs for standard industrial hygiene sampling and analytic methods.
- Procedures for scientific review.
- Required composition of scientific review boards.
- Procedures for data analysis.
- Procedures for communications.
Glossary of Terms used in this text
This text has been taken from Journal of Occupational Medicine / Volume 33 No. 12 / December 1991