Headlines from ‘good epidemiological practices’ for the Study protocol
The design of the study must be described in its entirety, and in sufficiently detailed manner, in a study protocol. The authorisations required in any field, including the protection of nominative data, must be obtained before field work begins.
The study protocol must include all the elements necessary to the understanding and implementation of the study. It is not possible to draw up an exhaustive list of every item which must be included in an epidemiological study protocol, for it must always be adapted to a particular context. It is possible, however, to list the information most frequently included in a protocol, while stressing that this list is by no means exhaustive and that the items which comprise it are not necessarily always present in every protocol:
1) A title describing the aim of the study;
2) The names, addresses, titles, functions and experience in epidemiology and the fields covered by the planned study of the study director and the other members of the team responsible for the study;
[3) The names, addresses and titles of sub-contractions, where applicable;]
4) The name, addresses and titles of the person in charge of the automatic processing of study data, and the categories of staff responsible for actually processing the data and of those who will have access to it, even for quality controls;
5) A summary of any commitments or activities of members of the team responsible for the study that might be a source of conflicting interests, and the justification of the conditions in which their participation in the study remains possible without infringing these recommendations;
6) The identity or identities of the financier(s) of the study and the reasons for their financial involvement;
7) A summary clearly explaining the objectives of the study, the main features of this design and strategy and the statistical analysis plan;
The overall objectives are
8) The origin and nature of the nominative data to be collected, why this is necessary and its relevance to the objective of the study;
9) A statement of the research hypotheses and how they can be tested (and how accurately) by the methods set forth in the study protocol;
Ho1:
Ho2:
[10) If the study is a preliminary study as defined above, an explicit statement to this effect and an explanation of the reasons for which these particular study methods were adopted;]
11) A sufficiently complete review of the relevant literature, made and presented in such a way that a third party is able to assess the context and significance of the proposed study and the methodological problems to be taken into account or given special considerations;
12) The results of any pilot study already undertaken, or if the study concerned is a pilot study, the criteria on the basis of which the decision will be taken to embark on a subsequent full-scale study;
13) A complete and sufficiently accurate description of the methodology of the proposed study, including its conception and the overall strategy, subject selection procedures and data input and verification procedures;
14) Reference to the size of the sample population to be studied, including reference to their limitations;
16) A description of the methods used to gather all the data needed for the study, and the methods used for studying any biases;
17) A description of the statistical methodology used for data analysis;
18) A description of the main limitations inherent in or resulting from the design of the study, the origin of the data and the statistical methods used;
19) A description of the criteria used to interpret the results the results of the study and assess their potential accuracy;
20) A description of the procedures followed to protect subjects against any risks, for example to protect their rights under the Law on Information processing and freedom, and the quality control procedures used to protect confidentiality and the integrity of the data and ensure the quality of data collection;
21) A description of all the residual or inevitable risks that the proposed study could involve for the subjects. Be sure to check in time, if permission for animal experiments is needed.
22) A description of the quality control and verification procedures envisaged;
23) The study schedule, including the starting date for data collection, the dates of the proposed control points and the completion date of the study;
24) A description of the proposed conditions for communicating the results of the study:
25) A description of the proposed conditions for the filing of the data and other documents obtained or produced in the course of the study, including an accurate description of the data and documents filed away and the criteria on the basis of which third parties will be allowed access to the data of document;
26) A complete and reasonably detailed account of the budget required for the whole study and its publication;
27) A statement naming the individual(s) or entity(ies) to whom the documents related to the study will belong, before and after filing.
