Follow us on




Q of the week

Q: How Do You Get Shingles?

Get the Answer: 

Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

Lithuania

Legislations

  1. Oviedo Convention on Human Rights and Biomedicine (2002)
  2. Law on Ethics of Biomedical Research, No. VIII-1679 (2007)
  3. Law on Ethics of Biomedical Research, No. VIII-1679 (2000)
  4. Law Amending the Law on Legal Protection of Personal Data, No. X-1444 (2008)
  5. Law on Pharmacy, No. X-709 (2006) (Lithuanian)


Regulations

MOH:

  1. Decree on the Procedure for the Estimation and Covering of Expenses Incurred by Research Subjects, No. 677 (2000)
  2. Decree on the List of the Documents to be Presented by the Sponsor of Biomedical Research and (or) by the Principal Investigator in Order to be Authorized to Conduct Biomedical Research, No. 29 (2001)
  3. Decree on the Procedure to Issue Approvals to Conduct Biomedical Research, No. V-2 (2008)
  4. Health Care Ministry Decree on the Procedure to Issue Approvals to Conduct Clinical Trial on Medicinal Product, No. V-435 (2006)

LBEC:

  1. Decree on the List of Documents to be Presented by the Sponsor of Medical Research and (or) by the Principal Investigator in Order to be Authorized to Conduct Biomedical Trial No. V-21 (2004)
  2. Decree on the Regulation for the Submission of the Documents to the Lithuanian Bioethics Committee to Issue Favourable Opinion to Conduct a Clinical Trial on Medicinal Products No. V-11 (2004)

SMCA:

  1. Decree on Pediatric Clinical Trials No. 70 (2002) 
  2. Detailed Guidance for the Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Notification of Substantial Amendments, and Declaration of the End of the Trial (2006)


Guidelines 

  1. LBEC: Recommendations on the Advertisements for Trial Subjects
 
 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
There are no events at this time

Links