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15 - References
16.1.11 - Copies of fully citable and publically available references, e.g. published manuscripts, conference posters and abstracts that pertains directly to the study being reported.
16.1.12 - Copies of fully citable and publically available references relevant to the study being reported.
16.1.8 - Audit Certificates should be any certificate (or statement) issued by the Good Clinical Practice group that performed the audit of the trial according to GCPs; i.e. monitoring of data quality, protocol adherance, informed consent procedures, assuring ethics committee approvals, study drug receipt, distribution and compliance etc. This may be a separate group within the company or could be from an outsourced group that performs such quality checks.
synopsis - Stand-alone document that is used for regulatory or other purposes without the rest of the clinical report.
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