Issuing favourable opinion to conduct clinical drug trial

Following the Law on Ethics of Biomedical Research favourable opinion to conduct clinical drug trial (thereinafter – CDT) is given by the Lithuanian Bioethics Committee (thereinafter – LBC). An approval of the State Medicines Control Agency (thereinafter – SMCA) is also mandatory.

Legal regulations on CDTs. (available in Lithuanian)

Where to apply to obtain favourable opinion to conduct CDT?

Favourable opinion to conduct CDT is issued by the LBC. The Regional Biomedical Research Ethics Committee(s) (thereinafter – Regional Committee) shall submit an opinion on the planned CDT to the LBC. The sponsor of CDT (or the representative of the sponsor) should submit all the required documents (originals documents and their copies) to the LBC. The number of required set(s) of documents depends on the number of Regional Committees to be involved in the evaluation of the CDT. E.g., if the CDT is planned to be conducted only at the research centre(s) located only in the Vilnius district, two sets of documents (original and copy) should be submitted to LBC by the sponsor of CDT (or the representative of the sponsor).

What are the documents to be submitted?

Below you will find the list of the documents to be submitted to the LBC by the sponsor of the CDT in order to obtain a favourable opinion to conduct CDT:

1. Main set of documents:
1.1. Request to grant favourable opinion to conduct CDT
1.2. Application form for authorization of a CDT (form in English in EudraCT database)
1.3. CDT protocol and its amendments.
1.4. Informed Consent Form (requirements in Lithuanian)
1.5. List of competent authorities within the community to which the application form has been submitted and their decision in details.
1.6. Authorization to enable the applicant to act on behalf of the sponsor (if the applicant is not the sponsor)

2. IMP related documents:
2.1. Investigator’s brochure
2.2. Summary of product characteristics (SmPC) (for products with marketing authorization in the community)
2.3. Applicable authorizations to cover trials or products with special characteristics (if available) e.g GMO, radiopharmaceuticals products.

3. Protocol related documents:
3.1. Summary of the protocol in Lithuanian
3.2. Ethical assessment form (form)
3.3. Peer review of the trial when available
3.4. Outline of all active trials with the same IMP

4. List of investigators with their Curriculum vitae (sample form of CV of investigator) (in Lithuanian)

5. Civil responsibility insurance policy of the principal investigator and the sponsor or letter of guarantee of insurance company.

6. Information about any other provisions on insurance or indemnity to cover the liability of the investigator and sponsor.

7. Agreement between the sponsor, the research centre and the principal investigator.

8. Other documents:
8.1. Statement of the head of a health care institution in which the CDT is planned to be conducted about having all the required facilities to conduct all the procedures required by the trial protocol (if this is not provided in the sponsor and the research centre)

Following the Guidelines for good clinical practice, any written information to be given to the research subjects should be submitted for the review of the LBC. It is recommended to follow the guidelines to advertising clinical trial, adopted by the LBC.

In order to facilitate the process of issuing the favourable opinion and avoid typos, we would appreciate receiving these forms also by e-mail ([email protected]) when submitting the application.

Procedure to issue a favourable opinion 

Decision about granting favourable opinion to conduct CDT is made at the meeting of the Group of Experts on Biomedical Research.

Meetings of this group are held once a month. Information about the upcoming meetings can be found on the LBCs web page. More information is also available by contacting the LBC by phone: +370 5 212 45 65 or e-mail [email protected].

The application shall be reviewed in a meeting if all the documents were duly completed and received no later than 20 working days before the date of the next scheduled meeting.

Favourable opinion must be issued or a reasoned refusal to grant it must be given within 60 calendar days from the registration of the documents.

This period may be extended by a 30 days in the case of trial involving medicinal products for gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms. This term might be extended by a further 90 days if consultation with expert is needed. In the case of xenogenic cell therapy, there is no time limit to the authorisation period.

It should be noted that the LBC is acting in accordance with the provision of the Lithuanian legal acts, including the Decree of the Ministry of Health on the Rules of Good Clinical Practice (12 June 1998, No. 320).

State fee for issuing a favourable opinion

There is a fixed state fee for examining the application and issuing favourable opinion to conduct CDT.

Making amendments in the course of the research

Amendments may be made to the conduct of a clinical trial following the requirements set by the LBC and the SMCA, which correspond to the guidelines of the European Commission.

The applicant shall submit a Notification of a Substantial Amendment Form (form in English in PDF; form in English in MS word) and other required documents.

More information about approvals for substantial amendments is available in Lithuanian.

The end of the CDT 

Within 90 days of the end of the CDT the sponsor shall notify the LBC that the clinical trial has ended and submit the Declaration of the End of a CDT (form in English in MS word, form in English in PDF).

The end of the trial in most cases will be the date of the last visit of the last patient undergoing the trial or other date provided in the protocol. 

More information

Specialist Asta Skrickienė, ph. +370 618 69357, e-mail: [email protected]