Clause 22 Non-Interventional Studies of Marketed Medicines

(13.4) Non-interventional studies that are prospective in nature and involve the collection of patient data must be conducted for a scientific purpose. They must comply with the following criteria:

• there must be a written study plan (observational plan/protocol) and written contracts between the health professionals and/or the healthcare organisations, institutes, academic faculties etc where the study will take place and the pharmaceutical company sponsoring the study, which specify the nature of the services to be provided and the payment for those services

• in countries where ethics committees are prepared to review such studies, the study protocol must be submitted to the ethics committee for review

• any remuneration must be reasonable and reflect the fair market value of the work

• the study must not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine

• the company’s scientific service must certify the protocol and supervise the conduct of the study

• the study results must be analysed and summaries made available within a reasonable period of time to the company’s scientific service, which shall maintain records of such reports; the summary report should be sent to health professionals who participated in the study. If the study results are important for the assessment of benefit/risk, the summary report should be immediately forwarded to the relevant competent authority

• representatives may only be involved in an administrative capacity and such involvement must be supervised by the company’s scientific service which will also ensure that the representatives are adequately trained for the role; such involvement must not be linked to the promotion of any medicine.

To the extent applicable, companies are encouraged to comply with Clause 22.1 for all other types of non-interventional studies, including epidemiological studies and registries and other studies that are retrospective in nature.

Companies must publish the summary details and results of non-interventional studies of marketed medicines in a manner consistent with their parallel obligations with respect to clinical trials, as set out in Clause 4.6.