Investigator Initiated Trial Agreement Template

Investigator initiated trial agreements (IITAs) are becoming increasingly popular in the world of clinical research. These agreements allow investigators to propose and conduct their own clinical trials, often with the support and resources of a larger organization or pharmaceutical company. However, to ensure that both parties are on the same page and that all legal and ethical considerations are taken into account, it is important to have a proper investigator initiated trial agreement template in place.

An investigator initiated trial agreement template should include several key elements. First, it should clearly define the roles and responsibilities of all parties involved in the trial. This includes the investigator, the sponsoring organization or company, any subcontractors or vendors, and any regulatory bodies or ethics committees involved in the approval process.

The template should also outline the scope of the trial, including the research objectives, the patient population to be included, and the specific interventions or treatments to be studied. It should also include any exclusion criteria or limitations that apply to the trial, as well as any safety monitoring or adverse event reporting requirements.

Another important element of the investigator initiated trial agreement template is the financial and intellectual property provisions. This should include details on how the trial will be funded, how any profits or royalties will be shared, and how any intellectual property resulting from the trial will be assigned or shared.

Finally, the template should address any legal considerations, such as liability, indemnification, and dispute resolution procedures. This can help to ensure that all parties are protected in case of any legal or ethical issues that may arise during the course of the trial.

Overall, a well-crafted investigator initiated trial agreement template is essential for ensuring that all parties involved in a clinical trial are clear on their roles, responsibilities, and obligations. By clearly outlining the scope, financial considerations, and legal provisions of the trial, these agreements can help to ensure that the research is conducted ethically, safely, and with the utmost attention to detail.