Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p23
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 60883–63936

manual (non-electronic) search techniques employed, including hand-searching, and the strategy used to identify any unpublished studies
    (g) a list of inclusion and exclusion criteria used to filter the literature
    (h) the number of studies identified from the search strategy, and number of studies excluded at each stage (Title filter, abstract filter and full-text filter) of filtering
    (i) a list of the publications (includes author, reference and publication details) excluded at the full text screening stage, and for each excluded publication, the reason(s) why it was considered not relevant (e.g. the inclusion criteria that were not met).

Note:

If a completed literature search yields a very large number of articles (e.g. 500) it is suggested using the inclusion and exclusion criteria to filter studies by reading the titles, then read. the abstracts to screen those left, and then finally screen with full-text reading.

The following data sources are not suitable:

     * articles published in newspapers, magazines, or newsletters.
     * books or book chapters. for consumers. or the general public
     * information intended for the general public on the internet, such as Wikipedia.

A relationship between a food or property of food and a health effect cannot be established from animal and in vitro studies alone. However, animal and in vitro studies may be provided in support of a relationship.

     B.2.2 Food-health relationships based on updating existing systematic reviews

Where the proposed food-health relationship is based on an existing systematic review, the application must:

    (a) demonstrate that the food-health relationship described in the existing systematic review is based on the same, or is within the scope of, the proposed food-health relationship
    (b) demonstrate that the existing review includes all relevant data from human studies (i.e. evidence in favour, equivocal evidence and evidence that is not in favour of the food-health relationship) given the time period and search criteria that it used
    (c) include a full copy of the existing systematic review
    (d) describe how the existing systematic review was updated.

Note:

The comparability with the methods of the existing systematic review could be demonstrated by showing that the updating search was done using the same criteria (i.e. points in paragraphs B.2.1 (a)–(f) and B.2.2(a)–(b) above) that were described by the authors. of an existing review. It is important to include the time period covered by an existing review and show how the updated review complements the existing review.

     B.3 Summarising literature for the proposed food-health relationship

The application must summarise the studies in humans for the proposed food-health relationship in tabular form, including objectives, sample size, participant characteristics, measurement methods, control for confounding, results and any adverse effects. If an existing systematic review is being updated, the tabulation must include studies from