Collaborating with external parties (universities, hospitals, etc.) have their own unique challenges that must be handled appropriately to ensure compliance with all applicable laws and regulations. Regulatory Affairs helps with determining what agreements, permissions, and procedures are needed to collaborate with external parties. Please see the FAQs below for more detail.
When should I get Regulatory Affairs involved?
It is highly recommended to engage with the Regulatory Affairs and Clinical Trials team early on in the study design process. The Regulatory Affairs and Clinical Trials team can identify possible challenges that may need to be addressed prior to submitting funding proposals and/or submitting to the IRB for review. Thees challenges can both delay the start of the study and add unexpected costs.
Do I need a clinical trial agreement?
A clinical trial agreement is a type of agreement between multiple institutions, organizations, and individuals who are involved in clinical trial to properly define the responsibilities of each party. Depending on the Georgia Tech's involvement and the specifics of the clinical trial, a clinical trial agreement may be needed. Each scenario is unique and will need to be properly assessed. When planning clinical trial with multiple external parties, please contact our office as soon as possible so we can assess the situation and get the process started.
What is needed for receiving materials?
Depending on what is being received at Georgia Tech, certain agreements (DUA, MTA), approvals (IRB, BSMC), and possibly clearance from the CDC and/or FDA may be needed. If a Georgia Tech study team is receiving data, specimens, or investigational medical products (e.g., drugs, biologics, medical devices), please contact our office as soon as possible so we can help ensure that all requirements are met.
What is needed for sending materials?
Depending on what is being sent from Georgia Tech to another institution, certain agreements (DUA, MTA), approvals (IRB, BSMC), and possibly clearance from the CDC and/or FDA may be needed. If a Georgia Tech study team is sending data, specimens, or investigational medical products (e.g., drugs, biologics, medical devices, etc.), please contact our office as soon as possible so we can help ensure that all requirements are met.
Please note that the Office of Exchange Agreements has a standard process in place for sending GT-owned investigational medical devices to external institutions, in which an MTA with very specific language is drafted and sent to the receiving institution.
What if I am only collaborating by conducting data analysis and/or helping with the manuscript?
If a Georgia Tech study team is only collaborating with data analysis and/or helping with drafting the manuscript, certain agreements and IRB approval may be needed depending on the specifics of what will be accessed/received by the Georgia Tech study team. Please contact our office as soon as possible so we can help ensure that all requirements are met.
What is needed with international collaboration?
The FDA has very specific laws, regulations, guidance, and procedures that must be followed if importing or exporting an investigational product (e.g., drugs, biologics, medical devices) to or from a foreign country. Additionally, certain agreements, approvals, and controls may need to be in place to ensure that all of the applicable local and FDA laws and regulations are being complied with. Therefore, please contact our office as soon as possible so we can help ensure that all requirements are met.