STATEMENT OF THE MINISTER OF HEALTH OF THE REPUBLIC OF LITHUANIA
ON APPROVAL OF THE DESCRIPTION OF THE PROCEDURE FOR ACCOUNTING, STORAGE AND PROVISION OF INFORMATION ON BIOMEDICAL RESEARCH
2010 May 6 No. V-405 Vilnius
Pursuant to the Law on Ethics of Biomedical Research of the Republic of Lithuania (Official Gazette Valstybės žinios, 2000, No. 44-1247) 13
paragraph 3 of this Article,
t v i r t i n u Accounting, storage and provision of information on biomedical research
description of the procedure (attached).
MINISTER OF HEALTH RAIMONDAS ŠUKYS
APPROVED
Minister of Health of the Republic of Lithuania
2010 May 6 by order no. V-405
DESCRIPTION OF ACCOUNTING, STORAGE AND PROVISION OF INFORMATION ON BIOMEDICAL RESEARCH AND INFORMATION ABOUT IT
I. GENERAL PROVISIONS
1. A description of the procedures for the accounting and collection, storage and provision of information on biomedical research
(hereinafter - the description of the procedure) is intended to determine the documents submitted for receipt by the Lithuanian Bioethics Committee
authorization to perform a biomedical research (hereinafter - biomedical research documents) and consent to perform
the clinical trial certificate (hereinafter referred to as the clinical trial dossier),
accounting, storage and collection and provision of information on them, as well as information on clinical trials
adverse events and reactions observed in drug trials; and
the procedure for accounting, accumulation and storage of other information related to research.
2. This description of the procedure has been prepared in accordance with the Law on Ethics of Biomedical Research of the Republic of Lithuania
(Official Gazette Valstybės žinios, 2000, No. 44-1247; 2007, No. 125-5093) and taking into account the
Minister 2006 May 31 order no. V-435
“On the Procedure for Authorization, Conduct and Control of Clinical Trials on Medicinal Products
description ”(Official Gazette Valstybės žinios, 2006, No. 62-2292), the right of the Republic of Lithuania to receive information from the state and
Law on Municipal Institutions and Bodies (Official Gazette Valstybės žinios, 2000, No. 10-236; 2005, No. 139-5008),
the Law on Public Information (Official Gazette, 1996, No. 71-1706; 2000, No. 75-2272; 2006, No. 82-3254),
European Commission
recommendations for the approval of a publicly available list of fields in the Eudra CT clinical trials database,
Having regard to the opinion of the European Commission no. Article 57 of the rules adopted pursuant to Regulation (EC) No 726/2004 and implementing them
recommendations no. 2008 / C168 / 02 of 4 February 2009, other acts.
3. The main terms used in this description of the procedure are defined by the biomedical regulations of the Republic of Lithuania
in the Law on Research Ethics and the Minister of Health of the Republic of Lithuania in 2006. May 31 in the order
No. V-435.
II. ACCOUNTING AND INFORMATION ON BIOMEDICAL INVESTIGATION DOCUMENTS AND CLINICAL MEDICINAL PRODUCT INVESTIGATION DOCUMENTS
PROCEDURES FOR THEIR COLLECTION AND STORAGE
4. Lithuanian Bioethics Committee, having received all biomedical research or clinical drug
investigation documents, forms a file, which is filled in with the documents related to the investigation during the respective investigation.
5. The file contains the 2006 file. May 31 Order No. of the Minister of Health of the Republic of Lithuania V-435 “On
Procedures for the Authorization, Conduct and Control of Clinical Trials on Medicinal Products
The documentation relating to the clinical trial of the medicinal product is set out in Annex 2. Also
the following documents are additionally kept in the file:
5.1. the conclusion (s) of the regional ethics committee (s) for biomedical research;
5.2. independent expert opinion (if any);
5.3. a certificate of consent to conduct a clinical trial of the medicinal product;
5.4. a declaration of the end of the clinical trial of the medicinal product;
5.5. a summary of the clinical trial report of the medicinal product;
5.6. all other documents related to the investigation.
6. The file shall contain the documents that must be submitted by the client and / or the principal of the biomedical research
researcher to obtain a permit for a biomedical research. The following documents are also additionally kept in the file:
6.1. the conclusion (s) of the regional ethics committee (s) for biomedical research;
6.2. independent expert opinion (if any);
6.3. permission to perform biomedical research;
6.4. a summary of the biomedical research performance report;
6.5. all other documents related to the investigation.
7. Documents included in the file shall be kept for 10 years from the date of receipt and registration
Declaration of completion of the clinical trial (informing about the last subject
last visit) or a notification of the end of the biomedical study was received.
8. In the absence of authorization for a biomedical study or consent to a clinical trial on a medicinal product
certificate, documents submitted for authorization or consent to conduct a clinical trial of a medicinal product
investigation certificate, filed in the file and kept for 5 years from the date of their registration.
9. At the end of the storage period of the documents of the biomedical research and clinical medicinal product, the following
documents shall be destroyed in accordance with the Law on Documents and Archives of the Republic of Lithuania (Official Gazette, 1995, No. 107-2389; 2004, No.
57-1982).
III. ADVERSE REACTIONS AND ADVERSE REACTIONS DETECTED DURING CLINICAL INVESTIGATIONS OF MEDICINAL PRODUCTS
CONSEQUENCES OF REACTIONS ACCOUNTING, ACCUMULATION AND STORAGE PROCEDURES
10. Information on adverse events and the consequences of adverse reactions shall be reported in accordance with the Authorizations
to perform clinical trials of medicinal products with a description of the procedure for the issue, performance and control of trials.
11. Reports of adverse reactions observed in a clinical trial
reactions to the investigational medicinal product or adverse events are reported to the appropriate clinical pharmacy
product study file.
12. Upon receipt of the annual safety report for a clinical trial of a medicinal product, receive this during that period
The notifications to the Document Expert Commission of the Lithuanian Bioethics Committee referred to in Item 11 of the Description of Procedure
are destroyed by a decision on the destruction of documents, or a decision is made on their further processing
and the annual safety report shall be kept in the study file of the clinical medicinal product concerned.
13. Upon receipt of the summary of the clinical trial report, the annual trial of the clinical trial
safety report (s) by decision of the Document Experts Commission of the Lithuanian Bioethics Committee
is destroyed by drawing up an act of destruction or a decision is taken on its further
storage.
14. Reports of an investigational medicinal product that is being studied in several clinical medicinal products
adverse reactions to the investigational medicinal product or adverse reactions were observed in
phenomena are grouped into separate files divided by the investigational medicinal product.
IV. PROCEDURE FOR THE PROVISION OF INFORMATION ON BIOMEDICAL (CLINICAL TREATMENT)
15. The Lithuanian Bioethics Committee provides only information on the ongoing biomedical (clinical medicinal product) research
information which is not a lawful state, official, professional, commercial or bank secret under the law, or
private information.
16. Applications of persons may be submitted orally (by telephone or when the person arrives directly at the Lithuanian Bioethics
Committee) shall be sent by post or courier or by electronic means
measures if it is possible to identify the applicant, indicating the purposes of such a request. Lithuanian bioethics
The Committee shall provide the following information relating to biomedical (Phase II-IV clinical trials) studies:
16.1. the name of the biomedical (clinical medicinal product) study;
16.2. the number of the protocol of the biomedical (clinical medicinal product) study;
16.3. the date of issue of the authorization for the biomedical study or the certificate of approval of the clinical trial of the medicinal product
and number;
16.4. the place (s) where the biomedical (clinical medicinal product) study will be performed;
16.5. the clinical trial phase of the medicinal product;
16.6. the names of the customer and the customer's representative.
17. The Lithuanian Bioethics Committee shall publish publicly available reports on permits issued
biomedical studies or approvals for Phase II-IV clinical trials of medicinal products,
providing the information specified in Paragraphs 16.1–16.6 of this Description of Procedure. Lithuanian Bioethics Committee on
shall publish the certificate of consent to conduct a clinical trial of a medicinal product issued only when it is issued by the State
permission of the Medicines Control Service under the Ministry of Health of the Republic of Lithuania to perform a clinical trial
examination of the medicinal product.
18. All other information relevant to the biomedical (clinical medicinal product) study
provided upon submission of a written request by the applicant to the Lithuanian Bioethics Committee and specifying such a request
goals. Before providing such information to the applicant, the biomedical (clinical)
medicinal product) study customer (customer's authorized representative).