Authentication and Audits

The Case Report Transformer should perform the following actions:

• Record the transaction in the audit log using ATNA

The Case Report Transformer may perform any of the following actions:

• Resolve local value sets into the expected value sets using a Concept Map, as defined by SVCM
• Validate any codes used in the case report form
• Resolve local identifiers for location using a canonical identifier, as defined by mCSD
• Validate any location identifiers against a facility directory, as defined by mCSD

Transformation Options

For Case Report Transform should be able perform three options for the Submit Case Report transaction. These options are defined for differing maturity levels of a Case Report Submitter. These options have the following expected actions:

FHIR Naive

This Case Report Submitter submits a tabular data set, associated to a Questionnaire resource, to the Case Report Transformer as a CSV file. The method of transmission is unspecified and a case Report Transformer may choose to accept other variants of tabular data (e.g. excel spreadsheet).. The Case Report Transformer must:

1. Retrieve a ConceptMap, using SVCM, which associates the column names in the tabular data to a Questionnaire item
2. Receive a tabular data from a Case Report Submitter
3. For each row of tabular data:
   1. Map the data row into a QuestionnaireResponse using a ConceptMap to map column names of the tabular data into QuestionnaireItems (Need Vlad's details)
   2. ​Extract relevant resouces into a Composition resource into a QuestionnaireResponse using Definition Based Extract as defined within the corresponding Questionnaire resource (the equivalent of the $extract operation)
   3. Create a Provenance resource linking the QuestionnaireResponse to the extracted Composition resource
4. Convert the submitted tabular data into a Binary resource (do we need?)
5. Create a Provenance resource linking the Binary resource (as an entity) to the Composition resources generated
6. Submit the ?Binary?, QuestionnaireReponse, Composition and Provenance resources to the Case Report Submitter as a Transaction Bundle

FHIR Aware

In this transaction, the Case Report Submitter submits one or more a Case Report form as a QuestionnaireResponse resources to the Case Report Transformer. The Case Report Submitter may submit this as a an individual QuestionnaireResponse resouce or as multiple QuestionnaireResponses resouces within a Transaction Bundle. The Case Report Transformer must:

1. For each QuestionnaireResponse:
   1. ​Extract relevant resouces into a Composition resource using Definition Based Extract as defined within the corresponding Questionnaire resource (the equivalent to the SDC $extract operation)
   2. Create a Provenance resource linking the QuestionnaireResponse to the extracted Composition resource
2. Submit the QuestionnaireResponse, Composition and Provenance resources to the Case Report Submitter as a ?Transaction Bundle?

FHIR Native

In this transaction, the Case Report Submitter submits one or more Case Report forms as a Composition resources to the Case Report Transformer. The Case Report Submitter may submit this as a an individual Composition resource or multiple Composition resources within a Transaction Bundle. The Case Report Transformer is not expected to modify the message received from the Case Report Submitter. The Case Report Transformer must:

1. Submit the Composition resources to the Case Report Submitter as a ?Transaction Bundle?