Clinical Research Study: Date: Principal Investigator: PI Contact/Requestor: Email: Phone: Study Duration: Definitions: For the purpose of this document the term refers to clinical trials, clinical studies or other research “Study” related activities. The term refers to any computing system, device or application that process or stores “Technology” information (e.g. computer applications, computers, servers, mobile devices and clinical devices), that is provided by the Study sponsor for use in the Study. Study Description: General Technology 1. Does the Study require the use of data center servers to be located at UCDHS? (either existing or a new server implementation) 2. Does the require a Technology dependency with any UCDHS production information system (e.g., Epic, Clarity, labs, radiology, pharmacy, etc.)? Security 3. Is unencrypted PII/PHI stored or processed on/by the propose Technology or elsewhere? Note: if yes please describe (within the Study Description above) the encryption algorithm and bit strength to be used. 4. Is PII/PHI stored/transmitted to an outside party (outside of UCDHS)? 5. Is there a requirement for removable media (e.g., flash/thumb drives, CD/DVDs, external hard drives, etc.) between UCDHS laptops/desktops and the proposed Technology? Networking 6. Will the Technology need to connect to any UCDHS wired or wireless networks? (All exceptions for Guest wireless Study use will be considered on a case-by-case basis) 7. Will the Technology require customer or vendor provided Wi-Fi networks (“hotspot”) or other networking requirements/equipment not provided and supported by UCDHS? Clinical Engineering Note: Clinical Engineering requires a separate review for clinical devices.
Clinical Research Study: Date: Principal Investigator: PI Contact/Requestor: Email: Phone: Study Duration: Definitions: For the purpose of this document the term “Study” refers to clinical trials, clinical studies or other research related activities. The term “Technology” refers to any computing system, device or application that process or stores information (e.g. computer applications, computers, servers, mobile devices and clinical devices), that is provided by the Study sponsor for use in the Study. Study Description: General Technology 1. Does the Study require the use of data center servers to be located at UCDHS? (either existing or a new server implementation) 2. Does the require a Technology dependency with any UCDHS production information system (e.g., Epic, Clarity, labs, radiology, pharmacy, etc.)? Security 3. Is unencrypted PII/PHI stored or processed on/by the propose Technology or elsewhere? Note: if yes please describe (within the Study Description above) the encryption algorithm and bit strength to be used. 4. Is PII/PHI stored/transmitted to an outside party (outside of UCDHS)? 5. Is there a requirement for removable media (e.g., flash/thumb drives, CD/DVDs, external hard drives, etc.) between UCDHS laptops/desktops and the proposed Technology? Networking 6. Will the Technology need to connect to any UCDHS wired or wireless networks? (All exceptions for Guest wireless Study use will be considered on a case-by-case basis) 7. Will the Technology require customer or vendor provided Wi-Fi networks (“hotspot”) or other networking requirements/equipment not provided and supported by UCDHS? Clinical Engineering Note: Clinical Engineering requires a separate review for clinical devices.
Research%20Request%20for%20Exception%20from%20Technology%20Evaluation.docx