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There is no intent to convey in this Sequence further details of the often complex consent and approval process. Further information about the protocol and ethics committee may be found in the Clinical Trials Modules, if present.

There is no identification of an individual responsible for the approval or granting consent, since in the case of a clinical trial or research subject granting informed consent, the presence of this information would breach de-identification requirements.

Multiple Sequence Items may be present; for example a Study may be approved for distribution for conducting multiple explicitly named protocols.

Whether or not the Instances have been adequately de-identified for any particular purpose of distribution is not defined by the Attributes in the Consent for Clinical Trial Use Sequence (0012,0083). Other Attributes address this, such as Patient Identity Removed (0012,0062), De-identification Method (0012,0063), De-identification Method Code Sequence (0012,0064) and Burned In Annotation (0028,0301). See also Annex E “Attribute Confidentiality Profiles (Normative)” in PS3.15.

It is possible that the list of Defined Terms for Distribution Type (0012,0084) may be extended in future for other purposes, not necessarily related to the conduct of clinical trials or research.