79C3C34C52B45572883A05D425EB0F82
V-24, Decree on the Procedure for Submission of the Documents to the Lithuanian Bioethics Committee to Issue Favorable Opinion to Conduct a Clinical Trial on Medicinal Products or Approval to Conduct Biomedical Research by the Sponsor of the Clinical Trial on Medicinal Product or Other Type of Biomedical Research (2016)
https://leaux.net/URLS/General/Lithuania_V-24_Decree_on_the_Procedure_for_Submission_of_the_Documents_2016.pdf
http://leaux.net/URLS/ConvertAPI Text Files/2BF8B438B298B693ECA97BF71BBCABD1.en.txt
Examining the file media/Synopses/2BF8B438B298B693ECA97BF71BBCABD1.html:
This file was generated: 2020-12-01 07:06:22
| 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
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): DIRECTOR OF THE LITHUANIAN BIOETHICS COMMITTEE
p.(None): ORDER
p.(None): ON THE DIRECTOR OF THE LITHUANIAN BIOETICS COMMITTEE DECEMBER 31, 2014
p.(None): D. ORDER NO. V-24 "ON DOCUMENTS TO BE PROVIDED BY A CLINICAL TRIAL FOR AN INVESTIGATION OR OTHER BIOMEDICAL
p.(None): THE CUSTOMER, ITS AUTHORIZED REPRESENTATIVE OR THE MAIN INVESTIGATOR, IN ORDER TO OBTAIN CONSENT TO A CLINICAL MEDICINAL PRODUCT
p.(None): PROCEDURES FOR SUBMISSION TO THE LITHUANIAN BIOETETICS COMMITTEE OF A TEST CERTIFICATE OR PERMIT FOR PERFORMANCE OF A BIOMEDICAL INVESTIGATION OF A PREPARATION
p.(None): DESCRIPTION OF APPROVAL ”
p.(None): 2016 January 15 No. V-3 Vilnius
p.(None): Documentation to be provided by a clinical trial or other biomedical application
p.(None): the sponsor, his authorized representative or the principal investigator in order to obtain approval to conduct a clinical trial
p.(None): submission of a study certificate or a permit to perform a biomedical study to the Lithuanian Bioethics Committee
p.(None): description of the procedure approved by the Director of the Lithuanian Bioethics Committee in 2014. 31 December by order no. V-24 “On
p.(None): Documentation to be provided by a clinical trial or other biomedical study
p.(None): the sponsor, his authorized representative or the principal investigator in order to obtain approval to conduct a clinical trial
p.(None): the submission of a certificate or permission to perform a biomedical study of a medicinal product in Lithuania
p.(None): approval of the description of the procedure to the Bioethics Committee ":
p.(None): 1. I amend point 6 to read as follows:
p.(None): „6. In cases where the opinion of the regional ethics committee (s) for biomedical research is required, the Lithuanian
p.(None): additional sets of required documents (originals or copies) shall be submitted to the Bioethics Committee for
p.(None): Regional Ethics Committee (s) for Biomedical Research and, where
p.(None): the conclusion of the Service for Health Care Activities under the Ministry of Health - additional required
p.(None): a set of documents (originals or copies) for State accreditation of health care activities
p.(None): service under the Ministry of Health. "
p.(None): 2. I amend point 7 to read as follows:
p.(None): „7. Documents are submitted to the Lithuanian Bioethics Committee by applying directly to the Lithuanian Bioethics Committee (Vilnius
p.(None): g. 16, LT-01402, Vilnius) at the time set by the Lithuanian Bioethics Committee, which can be obtained by phone (8 ~ 5) 212 45
p.(None): 65, electronically via the Public Electronic Services Portal (Electronic Government Gateway website
p.(None): www.epaslaugos.lt) or remotely (by sending by e-mail, signing with a secure electronic signature,
p.(None): by post or courier). "
p.(None): Director
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| opinion | philosophical differences/differences of opinion |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
Applicable Type / Vulnerability / Indicator Overlay for this Input