About this service
A clinical trial agreement is the legal framework that binds the sponsor, the investigating clinic and the researcher: who funds and manages the trial, who conducts it at the site, how risk is allocated and who answers to the participant if harm occurs. The Law of Georgia on Drugs and Pharmaceutical Activities imposes only a clear statutory minimum on this relationship — the sponsor's insurance obligation before the trial starts and the sanction regime for conducting a trial without a permit — while the remaining terms are left to the parties' agreement. It is precisely in this division, where the statute ends and freedom of contract begins, that the principal legal risk of every research project is hidden.
The sponsor's mandatory obligation: insurance for the duration of the trial
Under Article 5¹ of the law, before a clinical trial begins the sponsor — the person, company, institution or organisation responsible for initiating, managing or funding the trial — must arrange insurance of the trial's risk and liability for the period of the trial's conduct. The insurance must provide for reimbursement or compensation of the treatment costs of a participating person, to the extent those costs were needed for his or her participation in the trial. This requirement is an imperative norm: it cannot be altered or removed by contract. The agreement must therefore be drafted so that the insurance clauses genuinely secure coverage of those costs, make clear who pays the premium, who pursues reimbursement and how the parties deal with the insurer after treatment.
In negotiation practice this is exactly the clause that becomes contested: the investigating site asks that the policy directly cover its own costs related to a participant's treatment, while the sponsor seeks to keep the insurance no broader than the statutory floor. The law does not resolve this dispute — it only sets the lower limit below which an agreement becomes unlawful.
The permit sanction regime and its reflection in the agreement
Conducting a clinical trial of a pharmacological product without a permit is unlawful activity: under Article 37² of the law, conducting a clinical trial without a permit triggers a fine of GEL 4 000, and the same act committed repeatedly — a fine of GEL 8 000. The same sanction regime extends to the manufacture, export or import of a pharmaceutical product subject to special control and to operating without an authorised pharmacy, so the contractual allocation of risk must cover all of these boundaries and not merely the act of conducting the trial.
It is essential that the agreement expressly stipulates who is responsible for obtaining the permit, who assembles and files the permit documentation, within what deadlines, and how the risk of a fine is shared if the sanction results from a given party's neglect. The doubled amount of the repeated fine shows that the state does not forgive non-observance even after a first instance — and that risk is priced in the contract.
What remains to the parties' agreement
Beyond insurance and permits, the law leaves the content of the agreement to the parties. In practice this means the negotiation covers the trial budget and payment schedule, the legal fate and usage rights of the data obtained, the conditions for publishing results, the limits of the parties' liability to each other, the duration of the agreement and the manner of its termination or suspension. Because all of this is settled by agreement, well-formulated clauses build the architecture of the entire project, while vague formulations later cost a party the most — at the moment of dispute.
Participant rights and trial standards
The agreement cannot diminish the guarantees the participant holds by law. The rights of patients and healthy volunteers participating in a clinical trial are protected by Georgian legislation, and the trial is conducted in accordance with the standards and guidelines for preclinical and clinical trials approved by the minister. A healthy volunteer may undergo a bioequivalence study of a medicinal product, a pharmacokinetic study of a pharmacological product developed in Georgia, and a study that is permitted on a market under the control of a foreign or international regulator and that involves healthy volunteers.
A clinical trial of a pharmacological product intended as a progressive therapy medicinal product is admissible if the product is manufactured under a standard of good manufacturing practice recognised by the Government of Georgia, at an enterprise holding the authority to manufacture biological medicinal products. Conducting trials using the specific products and means defined by law is impermissible — this restriction must equally be reflected in the contract terms, since a clause consenting to its breach would itself be unlawful.
Frequently asked questions
Is insurance arranged by the sponsor mandatory?
Yes. Article 5¹ of the law obliges the sponsor, before the trial begins, to arrange insurance of the trial's risk and liability for the period of its conduct, covering reimbursement or compensation of a participant's treatment costs. This obligation cannot be cancelled or weakened by agreement.
What fine threatens a trial conducted without a permit?
Article 37² of the law provides a fine of GEL 4 000, and for the same act committed repeatedly — GEL 8 000. The sanction attaches directly to the conduct of the trial, which is why allocating the permit risk is one of the agreement's central clauses.
Can the agreement restrict a participant's rights?
No. The rights of participating patients and healthy volunteers are protected by Georgian legislation and cannot be reduced by the parties' agreement. The imperative insurance requirement is part of those guarantees.
Who sets the trial's remaining terms — budget, data, publication?
These matters are not determined by the statute and rest on agreement: within freedom of contract, the sponsor and the investigating centre themselves define the rules of funding, data ownership and publication of results.
How We Help on Legal.ge
We analyse the legal anatomy of a clinical trial agreement: we determine which clauses extend the law's imperative requirements and which are subject to the parties' agreement; we structure the insurance provisions so that reimbursement of a participant's treatment costs is genuinely secured; we allocate permit and fine risk between the parties; and we prepare the draft agreement for negotiations. Contact us whether you are a sponsor, an investigating centre or a researcher — and receive an agreement built to survive the entire life of the trial.