The most negotiated study clauses of clinical trial agreement are given as below:
1. Study subject injury clause:
This clause discusses how the subject or trial participant will be reimbursed in case of any injury during the study trials. The main area of tension within this clause is whether the sponsor will reimburse for the injury or not.
· Some reimbursements are covered but with some negotiation as what and how much is going to be covered.
· There are all areas of negotiations between sites and sponsors to determine that how cause is going to be determined and who is going to determine it and them what are the monetary reimbursements that the injured trial participant is going to be getting.
· Treatments for the injuries are also necessary to reimbursed.
The study subject injury reimbursement should be included in clinical trial agreement and should be made a priority by the sites.
2. Confidentiality clause:
This clause defines that what information coming out of the clinical trials should be considered confidential and what obligations that both sponsor and study site have maintain that confidentiality.
· The main area of tension within this clause lies within the sponsor’s desire to maintain the confidentiality of any information generated from the study for submission and application with FDA and other authorities. This information should be kept confidential.
· Site also has its desire to maintain the academic freedom to publish and share information for the public welfare and to promote research.
3. Publication rights clause:
This is one of the most negotiated clauses in CTA because there is important information for the sponsor and sites. This clause addresses the guidelines for the publications of clinical trial results, timing to perform publication, processes and width of the information that can be published and the methods used for the publication. According to this clause, it’s the sponsor’s goal to protect the confidential information because he has invested a lot of money.
4. Intellectual property clause:
This section addresses what the sites and sponsors are considering intellectual property of either to sponsor and to site. The sponsors want to maintain the ownership of the intellectual property and inventions as result of study. This CTA is to create the balance and to determine between what belongs to the sponsor and to sites.
5. Identification clause:
In clinical trial agreement, identification talks about the sponsor to hold harmless the site when they are participating in the trials and when things go wrong. This section talks about the managing risk for the sponsor and when sponsors are actually going to hold harmless the site.