MAIN CATEGORY | SUBCATEGORY | SUBCATEGORY | SUBCATEGORY | SUBCATEGORY | |
---|---|---|---|---|---|
REQUIREMENTS | |||||
 | Recipient | Recipient categorization | Roles | ||
Status | Authorized vs. non-authorized | ||||
Internal vs. external | |||||
Recipient background | Professional background | Academic staff | |||
Healthcare professionals | |||||
Office staff | |||||
Researchers | |||||
Other background | Organizations | ||||
Patients | |||||
Students | |||||
Recipient qualifications | Human-subjects training | ||||
Recipient relation to CDW | Affiliation | ||||
Reciprocity | |||||
Reuse | Reuse purpose | Research purposes | General research | ||
Clinical trials | |||||
Epidemiological studies | |||||
Feasibility check for research | |||||
Health services research | |||||
(Non-)human subject research | |||||
Observational studies | |||||
Personalized treatments | |||||
Health care purposes | Audit | ||||
Care management | |||||
Clinical care coordination | |||||
Clinical quality improvement | |||||
Facilitating organ, eye or tissue donation and transplantation | |||||
Public health reporting | |||||
Other reuse purposes | Grant application support | ||||
Marketing | |||||
Reuse setup | Clear documentation provided | ||||
Dissemination plan provided | |||||
Feasibility assessment provided | |||||
Funding provided | |||||
Process details provided | |||||
Reuse risk mitigation | Data protection | ||||
HIPAA compliance | |||||
IRB authorization | |||||
No contacting data subjects | |||||
No reidentification | |||||
No resharing without approval | |||||
Reuse values | Ethical soundness | Responsibleness | Compliance | ||
Privacy | |||||
Responsible reuse | |||||
Patient-centricity | Clinical relevance | ||||
Patients first | |||||
Non-competitiveness | Business issues | ||||
Collaboration principles | |||||
Non-profit | |||||
Scientific soundness | Good research conduct | ||||
Innovation | |||||
Merits | |||||
Appropriateness | Appropriateness of requests | ||||
Appropriateness of results | |||||
Mission consistent with CDW | |||||
Reputation | |||||
Formal requirements | Data reuse documents | Data access/ sharing/ use agreement | |||
Data collaboration agreement | |||||
Ethical agreements | |||||
Honorary/ substantive contract | |||||
Participation agreement | |||||
Term license agreement | |||||
General policies and regulations | Ethics | Consent | |||
IRB approval | |||||
Laws | General laws | ||||
Specific laws | |||||
Other general policies and regulations | FAIR principles | ||||
Statewide policy guidance | |||||
Local policies and regulations | Information governance | ||||
Data access policies | |||||
Data identifying/ access/ sharing/ publishing protocols | |||||
Data management policies | |||||
Privacy/ security policies | |||||
Protocol review guidelines | |||||
Research policy | |||||
SOPs | |||||
Fees | |||||
STRUCTURES AND PROCEDURES | |||||
 | Review bodies | Governance bodies | Board of directors | ||
Clinical committee | |||||
Department head | |||||
Director of professional services | |||||
Executive board | |||||
IRB | |||||
Project review committee | |||||
Privacy board | |||||
Privacy and security committee | |||||
Policy advisory groups | |||||
Use and access committee | |||||
Working groups | |||||
Scientific review bodies | Academic staff | ||||
Data analysts | |||||
Health information research unit | |||||
Research committee | |||||
Scientific peer-review | |||||
Patient review bodies | Patient-led oversight committee | ||||
Review values | General values | Appropriate competency | |||
Fine-grained control | |||||
Holistic governance | |||||
Reducing bias | Empirical evaluation | ||||
No conflict of interest | |||||
Objective review | |||||
Transparent review | |||||
Reducing investment | Effective review | ||||
Timely review | |||||
Managing competitiveness | Collaboration | ||||
Community before individual | |||||
ACCESS | |||||
 | Access limitations | Limited data | Aggregated data set | ||
De-identified data set | |||||
Limited data set | |||||
Limited location | Remote access | ||||
View only | |||||
Virtual access | |||||
Limited time |