Page Comparison

Problem Statement:

Consent statements in caTissue OpenSpecimen are not coded or structured in terms of an ontological standard. Searching for types of consent in caTissue OpenSpecimen is problematic and is usually only completed by searching for text terms in the statement itself. A new method for categorizing and editing consent in caTissue OpenSpecimen is needed.

Possible Mitigations:

• Usage of a consent ontology
• Integration with IRB systems
• Link consent to an external management system
• Utilize existing consent ontologies where possible, RPMS being a possible choice. Permission concepts for procedures exist in SNOMED-CT and in LOINC however they are procedural based more than for generalized research usage. If none are acceptable a new group of concept types could be proposed and added to caTissueOpenSpecimen.

Possible Implementations:

• Integrate with local IRB management systems to insert consent statements into caTissue OpenSpecimen at the time of automated patient registration and protocol construction.
• Create a more robust consent management and statement statement editor within caTissueOpenSpecimen
• Add consent ontology (RPMS) to permissible values

...

Initial break down of functional requirements:

1. As a caTissue OpenSpecimen administrator I need to map consent statements that are not mapped by the researcher.
   1. Create admin UI to add mappings to unmapped consent statements.
2. As a caTissue OpenSpecimen administrator I need to add new consent types when required.
   1. Create admin UI to update/add/delete consent categories. (RPMS standards and local categories.)
3. As a researcher, I need to search by types of consent and consent responses.
   
   1. Update database to support linking consent tier statements to RPMS standard categories.
4. As a PI, I need to select standard statements when possible.
   1. Update consent UI to support selection of existing standard terminologies.
5. As a PI, I need to enter consent statements that are not currently in caTissueOpenSpecimen.
   1. Continue functionality of entering consent statements, but allow for the PI to map text to the standard ontology.
6. PLEASE ADD MORE REQUIREMENTS AND COMMENT ON THE DOCUMENT IN THE COMMENTS SECTION

...