Page 30 - eBook Version 8 Book 1 of 2 JUL 2022

Agreement
Alternate Names? Non-Disclosure
Originating Party
Secondary Party
Why?
When is it needed?
When to initiate?
Who can
Confidentiality Disclosure Agreement (CDA)
Facility Use Agreement (FUA)
Agreement (NDA)
N/A
External Sponsor
UTSW – Sponsored Programs Administration (SPA)
External sponsor
Share and protect proprietary information
When working with an external sponsor
During first discussions with the external sponsor. After Children’s Health has been selected as a study site
After Children’s Health been selected as a site
When CH data will be sent to another entity
UTSW - SPA
Clinical Trial Agreement (CTA)
Clinical Trial Contract (CTC)
External Sponsor Institution/entity to send data
UTSW - SPA
Defines scope of work & establishes legal and financial terms
Allows data with PHI to be sent between institutions
When working with an external non- federal sponsor When data will be sent and no other contract is in place
Sponsor UTSW – SPA
Data Use Agreement (DUA)
N/A
Institution/entity to which data will be sent
Sponsor Employer of Investigator
Limited Data Set (LDS) – a type of a DUA
N/A
Institution/entity to send data
Institution/entity to which data will be sent
Allows data containing limited PHI (dates, location [city, state, 5-digit zip code] and ages in years, months, days or hours) to be sent between institutions
When data will be sent and no other contract is in place
When CH data will be sent to another entity
Other institution Employer of Investigator
Materials Transfer Agreement (MTA)
N/A
Institution/entity to send materials
Institution/entity to which materials will be sent
Allows biologic/research materials to be sent between institutions
When materials will be sent and no other contract is in place
When CH materials will be sent to another entity
Other institution Employer of Investigator
Service Order Agreement (SOA)
N/A
Institution requesting CH to perform research services (UTSW –SPA)
CH – Research Administration Finance
Contracts CH to perform research services for a particular study protocol
All studies for which CH will bill for services rendered
Protocol has been sent to PI/Study team
Other institution
VP – Research at CH
Grant Management Order (GMO)
N/A
Entity requesting a % of a CH employee’s time
CH – Research Administration Finance
Contracts for a % of an employee’s time for any amount of studies
When a PI requests personnel support
When personnel support has been requested
Investigator VP – Research at CH
Clinical Trial Coverage Analysis (CTCA)
N/A
UTSW SPA
External sponsor
Sets negotiations for study budget, included in the CTA
Whenever UTSW will contract with external sponsor
Protocol has been sent to PI/Study team
VP – Financial Affairs at UTSW Investigator
Children’s Health (CH) – Director, Research Administration
Protect and indemnify Children’s Health from liability
When working with an industry sponsor (e.g., drug company)
Sponsor
VP – Research at CH
execute?
UTSW Grant Specialist