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 contract.
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:
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:
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: 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, 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:
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:
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 extent possible.
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:
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.
Examples of research program activities for which SOPs could be established include:
Glossary of Terms used in this textNOTE
This text has been taken from Journal of Occupational Medicine / Volume 33 No. 12 / December 1991