Commission Directive 2009/9/ECShow full title

C. FIELD STUDIES

Particulars concerning field studies shall be sufficiently detailed to enable an objective judgement to be made. They shall include the following:

1.

a summary;

2.

name, address, function and qualifications of the investigator in charge;

3.

place and date of administration, identity code that can be linked to the name and address of the owner of the animal(s);

4.

details of the trial protocol, giving a description of the methods, apparatus and materials used, details such as the route of administration, the schedule of administration, the dose, the categories of animals, the duration of observation, the serological response and other investigations carried out on the animals after administration;

5.

in the case of control animals, whether they received a placebo or no treatment;

6.

identification of the treated and control animals (collective or individual, as appropriate), such as species, breeds or strains, age, weight, sex, physiological status;

7.

a brief description of the method of rearing and feeding, stating the nature and quantity of any additives contained in the feed;

8.

all the particulars on observations, performances and results (with averages and standard deviation); individual data shall be indicated when tests and measurements on individuals have been carried out;

9.

all observations and results of the studies, whether favourable or unfavourable, with a full statement of the observations and the results of the objective tests of activity required to evaluate the product; the techniques used must be specified and the significance of any variations in the results explained;

10.

effects on the animals’ performance;

11.

the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;

12.

the nature, frequency and duration of observed adverse reactions;

13.

occurrence and course of any intercurrent disease;

14.

all details concerning veterinary medicinal products (other than the product under study) which have been administered either prior to or concurrently with the test product or during the observation period; details of any interactions observed;

15.

an objective discussion of the results obtained, leading to conclusions on the safety and efficacy of the product.