Table 3

List of common clinical information released in the Health Canada Public Release of Clinical Information database

CTD/eCTD module	Types of information	Description	Additional information for researchers
2.5	Clinical overview	Overview of product development rationale, biopharmaceutics, pharmacokinetics, efficacy, safety and benefit/risk conclusions.	Provides factual summary of clinical information and conclusion of critical analysis of the results, discussion and interpretation of clinical findings on pertinent studies.
2.7.1	Summary of biopharmaceutics and associated analytical methods	Summary of all in vitro or in vivo biopharmaceutic studies including their background/overview, methods, results and conclusion.	Provide a tabular listing of all corresponding (ie, biopharmaceutic, pharmacological, clinical efficacy, clinical safety) studies. Provide detailed factual summary of all studies included in the submission.
2.7.2	Summary of clinical pharmacology studies	Summary of all in vitro or in vivo PK and PD studies including their background/overview, methods, results and conclusion.
2.7.3	Summary of clinical efficacy	Summary of all clinical studies conducted to evaluate efficacy (dose–response, comparative efficacy, long-term efficacy, and efficacy studies in population subsets), including their background/overview, methods, results and conclusion.
2.7.4	Summary of clinical safety	Summary of data relevant to safety in the intended patient population, including results from individual CSRs and other relevant reports.
5.3.1	Reports of biopharmaceutic studies	CSRs of studies evaluating rate and extent of release of the active substance from the medicinal product.	Provide a tabular listing of all corresponding biopharmaceutic, pharmacological, clinical efficacy, clinical safety) studies. Contain CSRs, protocol and amendments, statistical analysis plans, sample case report forms and individual adverse event narrative files. Maybe useful for: Incorporating unreported results and unpublished trials into a systematic review and/or meta-analysis. Critically appraising integrity of methods and results from corresponding published trials.
5.3.2	Reports of studies pertinent to pharmacokinetics using human biomaterials	Clinical study reports of in vitro or ex vivo studies using materials derived from human sources to evaluate PK properties of drug substances.
5.3.3	Reports of human PK studies	in vivo PK studies.
5.3.4	Reports of human PD studies	Reports of studies with a primary objective of determining the PD effects of a drug product.
5.3.5	Reports of efficacy and safety studies	Reports of all clinical studies of efficacy and/or safety carried out with the drug, including all completed and all ongoing studies of the drug in proposed and non-proposed indications.
5.3.6	Reports of postmarketing experience	Reports that summarise marketing experience, including all significant safety observations, for all products that are currently marketed.	Provides postmarketing data from that have been marketed in other regions.

CSR, Clinical Study Report; CTD, Common Technical Document; eCTD, Electronic Common Technical Document; PD, pharmacodynamic; PK, pharmacokinetics.