OpenLegislation

Division 10 F1

United Kingdom

Original text. Later amendments are not shown.

Results: comprising the following subsections:

  1. 10.1.

    Participants: numbers of study subjects at each stage of study. In the case of a systematic review or meta-analysis, number of studies screened, assessed for eligibility and included in the review with reasons for exclusion at each stage.

  2. 10.2.

    Descriptive data: characteristics of study participants, information on exposures and potential confounders and number of participants with missing data. In the case of a systematic review or meta-analysis, characteristics of each study from which data were extracted.

  3. 10.3.

    Outcome data: numbers of study subjects across categories of main outcomes.

  4. 10.4.

    Main results: unadjusted estimates and, if applicable, confounder-adjusted estimates and their precision. Where relevant, estimates of relative risk shall be translated into absolute risk for a meaningful time period.

  5. 10.5.

    Other analyses.

  6. 10.6.

    Adverse events and adverse reactions.

Annotations

Textual amendments

F1

Regulation revoked in part (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 9 para. 1(t) (subject to transitional provisions in S.I. 2012/1916, Sch. 33A); 2020 c. 1, Sch. 5 para. 1(1)