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SCHEDULES

[F1SCHEDULE 12AU.K.Further provision as to the performance of pharmacovigilance activities

Textual Amendments

PART 9U.K.Post-authorisation safety studies

Format of the study protocolU.K.

30.  The study protocol for a non-interventional post-authorisation safety studies must be submitted in the following format—

(a)title: informative title including a commonly used term indicating the study design and the medicinal product, substance or drug class concerned, and a sub-title with a version identifier and the date of the last version;

(b)name of holder;

(c)responsible parties including a list of all collaborating institutions and other relevant study sites.

(d)abstract, which must consist of a stand-alone summary of the study protocol, including the following subsections—

(i)title with subtitles including version and date of the protocol and name and affiliation of the main author,

(ii)rationale and background,

(iii)research question and objectives,

(iv)study design,

(v)population,

(vi)variables,

(vii)data sources,

(viii)study size,

(ix)data analysis, and

(x)milestones;

(e)amendments and updates, namely any substantial amendment and update to the study protocol after the start of data collection, including a justification for the amendment or update, the date of the change, and a reference to the section of the protocol where the change has been made.

(f)milestones, namely a table with planned dates for the following milestones—

(i)start of data collection,

(ii)end of data collection,

(iii)any study progress report as referred to in regulation 198(2),

(iv)any interim report of study results, if applicable, and

(v)final report of study results;

(g)rationale and background, namely a description of any safety hazard, the safety profile or the risk management measures that led to the study being imposed as an obligation for a UKMA(GB) [F2or a UKMA(UK)(Category 1)];

(h)research question and objectives in accordance with the decision of the licensing authority in imposing the study as an obligation;

(i)research methods, namely a description of the research methods, including—

(i)study design,

(ii)setting, namely the study population defined in terms of persons, place, time period, and selection criteria, including the rationale for any inclusion and exclusion criteria: where any sampling from a source population is undertaken, a description of the source population and details of sampling methods must be provided and where the study design is a systematic review or a meta-analysis, the criteria for the selection and eligibility of studies must be explained,

(iii)variables,

(iv)data sources, namely strategies and data sources for determining exposures, outcomes and all other variables relevant to the study objectives: where the study will use an existing data source, such as electronic health records, any information on the validity of the recording and coding of the data must be reported and in the case of a systematic review or meta-analysis, the search strategy and processes and any methods for confirming data from investigators must be described,

(v)study size, namely any projected study size, precision sought for study estimates and any calculation of the study size that can minimally detect a pre-specified risk with a pre-specified interpretative power,

(vi)data management,

(vii)data analysis,

(viii)quality control, and

(ix)limitations of the research methods;

(j)protection of human subjects, namely safeguards in order to comply with national requirements for ensuring the well-being and rights of participants in non-interventional post-authorisation safety studies;

(k)management and reporting of adverse events or adverse reactions and other medically important events while the study is being conducted;

(l)plans for disseminating and communicating study results; and

(m)references.]

Textual Amendments