79C3C34C52B45572883A05D425EB0F82
V-405, Decree on the Procedure for Keeping a Record of Biomedical Research, Collecting, Storage, and Providing Information on Biomedical Research (2010)
https://leaux.net/URLS/General/Lithuania_V-405_Decree_on_the_Procedure_for_Keeping_a_Record_of_Biomedical_Research_Collecting_Storage_and_Providing_Information_on_Biomedical_Research_2010.pdf
http://leaux.net/URLS/ConvertAPI Text Files/0E994BB8A85B124AA2A09373E44A04B4.en.txt
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This file was generated: 2020-12-01 07:02:34
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Drug Usage
Searching for indicator drug:
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p.(None): STATEMENT OF THE MINISTER OF HEALTH OF THE REPUBLIC OF LITHUANIA
p.(None): ON APPROVAL OF THE DESCRIPTION OF THE PROCEDURE FOR ACCOUNTING, STORAGE AND PROVISION OF INFORMATION ON BIOMEDICAL RESEARCH
p.(None): 2010 May 6 No. V-405 Vilnius
p.(None): Pursuant to the Law on Ethics of Biomedical Research of the Republic of Lithuania (Official Gazette Valstybės žinios, 2000, No. 44-1247) 13
p.(None): paragraph 3 of this Article,
p.(None): t v i r t i n u Accounting, storage and provision of information on biomedical research
p.(None): description of the procedure (attached).
p.(None): MINISTER OF HEALTH RAIMONDAS ŠUKYS
p.(None): APPROVED
p.(None): Minister of Health of the Republic of Lithuania
p.(None): 2010 May 6 by order no. V-405
p.(None): DESCRIPTION OF ACCOUNTING, STORAGE AND PROVISION OF INFORMATION ON BIOMEDICAL RESEARCH AND INFORMATION ABOUT IT
p.(None): I. GENERAL PROVISIONS
p.(None): 1. A description of the procedures for the accounting and collection, storage and provision of information on biomedical research
p.(None): (hereinafter - the description of the procedure) is intended to determine the documents submitted for receipt by the Lithuanian Bioethics Committee
p.(None): authorization to perform a biomedical research (hereinafter - biomedical research documents) and consent to perform
p.(None): the clinical trial certificate (hereinafter referred to as the clinical trial dossier),
p.(None): accounting, storage and collection and provision of information on them, as well as information on clinical trials
p.(None): adverse events and reactions observed in drug trials; and
p.(None): the procedure for accounting, accumulation and storage of other information related to research.
p.(None): 2. This description of the procedure has been prepared in accordance with the Law on Ethics of Biomedical Research of the Republic of Lithuania
p.(None): (Official Gazette Valstybės žinios, 2000, No. 44-1247; 2007, No. 125-5093) and taking into account the
p.(None): Minister 2006 May 31 order no. V-435
p.(None): “On the Procedure for Authorization, Conduct and Control of Clinical Trials on Medicinal Products
p.(None): description ”(Official Gazette Valstybės žinios, 2006, No. 62-2292), the right of the Republic of Lithuania to receive information from the state and
p.(None): Law on Municipal Institutions and Bodies (Official Gazette Valstybės žinios, 2000, No. 10-236; 2005, No. 139-5008),
p.(None): the Law on Public Information (Official Gazette, 1996, No. 71-1706; 2000, No. 75-2272; 2006, No. 82-3254),
p.(None): European Commission
p.(None): recommendations for the approval of a publicly available list of fields in the Eudra CT clinical trials database,
p.(None): 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
p.(None): recommendations no. 2008 / C168 / 02 of 4 February 2009, other acts.
p.(None): 3. The main terms used in this description of the procedure are defined by the biomedical regulations of the Republic of Lithuania
p.(None): in the Law on Research Ethics and the Minister of Health of the Republic of Lithuania in 2006. May 31 in the order
p.(None): No. V-435.
p.(None): II. ACCOUNTING AND INFORMATION ON BIOMEDICAL INVESTIGATION DOCUMENTS AND CLINICAL MEDICINAL PRODUCT INVESTIGATION DOCUMENTS
p.(None): PROCEDURES FOR THEIR COLLECTION AND STORAGE
p.(None): 4. Lithuanian Bioethics Committee, having received all biomedical research or clinical drug
p.(None): investigation documents, forms a file, which is filled in with the documents related to the investigation during the respective investigation.
p.(None): 5. The file contains the 2006 file. May 31 Order No. of the Minister of Health of the Republic of Lithuania V-435 “On
p.(None): Procedures for the Authorization, Conduct and Control of Clinical Trials on Medicinal Products
p.(None): The documentation relating to the clinical trial of the medicinal product is set out in Annex 2. Also
p.(None): the following documents are additionally kept in the file:
p.(None): 5.1. the conclusion (s) of the regional ethics committee (s) for biomedical research;
p.(None): 5.2. independent expert opinion (if any);
p.(None): 5.3. a certificate of consent to conduct a clinical trial of the medicinal product;
p.(None): 5.4. a declaration of the end of the clinical trial of the medicinal product;
p.(None): 5.5. a summary of the clinical trial report of the medicinal product;
p.(None): 5.6. all other documents related to the investigation.
p.(None): 6. The file shall contain the documents that must be submitted by the client and / or the principal of the biomedical research
p.(None): researcher to obtain a permit for a biomedical research. The following documents are also additionally kept in the file:
p.(None): 6.1. the conclusion (s) of the regional ethics committee (s) for biomedical research;
p.(None): 6.2. independent expert opinion (if any);
p.(None): 6.3. permission to perform biomedical research;
p.(None): 6.4. a summary of the biomedical research performance report;
p.(None): 6.5. all other documents related to the investigation.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): (hereinafter - the description of the procedure) is intended to determine the documents submitted for receipt by the Lithuanian Bioethics Committee
p.(None): authorization to perform a biomedical research (hereinafter - biomedical research documents) and consent to perform
p.(None): the clinical trial certificate (hereinafter referred to as the clinical trial dossier),
p.(None): accounting, storage and collection and provision of information on them, as well as information on clinical trials
p.(None): adverse events and reactions observed in drug trials; and
p.(None): the procedure for accounting, accumulation and storage of other information related to research.
p.(None): 2. This description of the procedure has been prepared in accordance with the Law on Ethics of Biomedical Research of the Republic of Lithuania
p.(None): (Official Gazette Valstybės žinios, 2000, No. 44-1247; 2007, No. 125-5093) and taking into account the
p.(None): Minister 2006 May 31 order no. V-435
p.(None): “On the Procedure for Authorization, Conduct and Control of Clinical Trials on Medicinal Products
p.(None): description ”(Official Gazette Valstybės žinios, 2006, No. 62-2292), the right of the Republic of Lithuania to receive information from the state and
p.(None): Law on Municipal Institutions and Bodies (Official Gazette Valstybės žinios, 2000, No. 10-236; 2005, No. 139-5008),
p.(None): the Law on Public Information (Official Gazette, 1996, No. 71-1706; 2000, No. 75-2272; 2006, No. 82-3254),
p.(None): European Commission
p.(None): recommendations for the approval of a publicly available list of fields in the Eudra CT clinical trials database,
p.(None): 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
p.(None): recommendations no. 2008 / C168 / 02 of 4 February 2009, other acts.
p.(None): 3. The main terms used in this description of the procedure are defined by the biomedical regulations of the Republic of Lithuania
p.(None): in the Law on Research Ethics and the Minister of Health of the Republic of Lithuania in 2006. May 31 in the order
p.(None): No. V-435.
p.(None): II. ACCOUNTING AND INFORMATION ON BIOMEDICAL INVESTIGATION DOCUMENTS AND CLINICAL MEDICINAL PRODUCT INVESTIGATION DOCUMENTS
p.(None): PROCEDURES FOR THEIR COLLECTION AND STORAGE
p.(None): 4. Lithuanian Bioethics Committee, having received all biomedical research or clinical drug
p.(None): investigation documents, forms a file, which is filled in with the documents related to the investigation during the respective investigation.
p.(None): 5. The file contains the 2006 file. May 31 Order No. of the Minister of Health of the Republic of Lithuania V-435 “On
p.(None): Procedures for the Authorization, Conduct and Control of Clinical Trials on Medicinal Products
p.(None): The documentation relating to the clinical trial of the medicinal product is set out in Annex 2. Also
p.(None): the following documents are additionally kept in the file:
p.(None): 5.1. the conclusion (s) of the regional ethics committee (s) for biomedical research;
p.(None): 5.2. independent expert opinion (if any);
p.(None): 5.3. a certificate of consent to conduct a clinical trial of the medicinal product;
p.(None): 5.4. a declaration of the end of the clinical trial of the medicinal product;
p.(None): 5.5. a summary of the clinical trial report of the medicinal product;
p.(None): 5.6. all other documents related to the investigation.
p.(None): 6. The file shall contain the documents that must be submitted by the client and / or the principal of the biomedical research
p.(None): researcher to obtain a permit for a biomedical research. The following documents are also additionally kept in the file:
p.(None): 6.1. the conclusion (s) of the regional ethics committee (s) for biomedical research;
p.(None): 6.2. independent expert opinion (if any);
p.(None): 6.3. permission to perform biomedical research;
p.(None): 6.4. a summary of the biomedical research performance report;
p.(None): 6.5. all other documents related to the investigation.
p.(None): 7. Documents included in the file shall be kept for 10 years from the date of receipt and registration
p.(None): Declaration of completion of the clinical trial (informing about the last subject
p.(None): last visit) or a notification of the end of the biomedical study was received.
p.(None): 8. In the absence of authorization for a biomedical study or consent to a clinical trial on a medicinal product
p.(None): certificate, documents submitted for authorization or consent to conduct a clinical trial of a medicinal product
p.(None): investigation certificate, filed in the file and kept for 5 years from the date of their registration.
p.(None): 9. At the end of the storage period of the documents of the biomedical research and clinical medicinal product, the following
p.(None): 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.
p.(None): 57-1982).
p.(None): III. ADVERSE REACTIONS AND ADVERSE REACTIONS DETECTED DURING CLINICAL INVESTIGATIONS OF MEDICINAL PRODUCTS
p.(None): CONSEQUENCES OF REACTIONS ACCOUNTING, ACCUMULATION AND STORAGE PROCEDURES
p.(None): 10. Information on adverse events and the consequences of adverse reactions shall be reported in accordance with the Authorizations
p.(None): to perform clinical trials of medicinal products with a description of the procedure for the issue, performance and control of trials.
p.(None): 11. Reports of adverse reactions observed in a clinical trial
...
Orphaned Trigger Words
p.(None): IV. PROCEDURE FOR THE PROVISION OF INFORMATION ON BIOMEDICAL (CLINICAL TREATMENT)
p.(None): 15. The Lithuanian Bioethics Committee provides only information on the ongoing biomedical (clinical medicinal product) research
p.(None): information which is not a lawful state, official, professional, commercial or bank secret under the law, or
p.(None): private information.
p.(None): 16. Applications of persons may be submitted orally (by telephone or when the person arrives directly at the Lithuanian Bioethics
p.(None): Committee) shall be sent by post or courier or by electronic means
p.(None): measures if it is possible to identify the applicant, indicating the purposes of such a request. Lithuanian bioethics
p.(None): The Committee shall provide the following information relating to biomedical (Phase II-IV clinical trials) studies:
p.(None): 16.1. the name of the biomedical (clinical medicinal product) study;
p.(None): 16.2. the number of the protocol of the biomedical (clinical medicinal product) study;
p.(None): 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
p.(None): and number;
p.(None): 16.4. the place (s) where the biomedical (clinical medicinal product) study will be performed;
p.(None): 16.5. the clinical trial phase of the medicinal product;
p.(None): 16.6. the names of the customer and the customer's representative.
p.(None): 17. The Lithuanian Bioethics Committee shall publish publicly available reports on permits issued
p.(None): biomedical studies or approvals for Phase II-IV clinical trials of medicinal products,
p.(None): providing the information specified in Paragraphs 16.1–16.6 of this Description of Procedure. Lithuanian Bioethics Committee on
p.(None): shall publish the certificate of consent to conduct a clinical trial of a medicinal product issued only when it is issued by the State
p.(None): permission of the Medicines Control Service under the Ministry of Health of the Republic of Lithuania to perform a clinical trial
p.(None): examination of the medicinal product.
p.(None): 18. All other information relevant to the biomedical (clinical medicinal product) study
p.(None): provided upon submission of a written request by the applicant to the Lithuanian Bioethics Committee and specifying such a request
p.(None): goals. Before providing such information to the applicant, the biomedical (clinical)
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| drug | Drug Usage |
| opinion | philosophical differences/differences of opinion |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
Applicable Type / Vulnerability / Indicator Overlay for this Input