Ethics Committee

Regular Committee meetings take place every first Wednesday of the month. Please send documents to be discussed at least 14 days before the meeting for new study submissions and 7 days before the meeting for other documents (requests submitted after this deadline will be automatically referred to the next meeting's agenda). Please, submit all documents electronically to : eticka.komise@homolka.cz

Planned meeting dates for 2020:

  • 5. 2. 2020
  • 4. 3. 2020
  • 1. 4. 2020
  • 6. 5. 2020
  • 3. 6. 2020
  • 5. 8. 2020
  • 2. 9. 2020
  • 7. 10. 2020
  • 4. 11. 2020
  • 2. 12. 2020
  • 6. 1. 2021

Meeting dates may be changed due to holidays, illness or other unexpected events (Changes will be shown on our web pages).

Documents for downloading (including document language):
General statement PDF
Rules and committee Procedures PDF
Price list of services and activities  PDF
Annual report / Final report PDF
Procedures and timetables PDF

Ethics Committee medical devices questionnaire

doc, PDF
Ethics Committee questionnaire for drug products doc, PDF
Ethics Committee questionnaire for grants and research projects doc, PDF

List of documents to be submitted by the applicant in support of application for approval of a new clinical trial (including required language):

  • Signed hard copy application for new study CZ

  • Trial Original language or CZ

  • Protocol summary CZ

  • Informed Consent Form CZ (Without unnecessary use of expert terminology which cannot be easily understood by trial subjects.If such terms cannot be avoided, they must be clearly explained)

  • Written information for clinical trial subjects CZ

  • Description of recruitment process CZ

  • Patient questionnaires (if applicable) CZ

  • Investigator’s brochure Original language or CZ

  • Information about financial or other compensation offered to clinical trial subjects CZ

  • Curriculum vitae CZ or EN

  • Insurance contract including certifikát CZ or ENG

  • Draft version of the contract between Sponsor and Institution EN/CZ

  • Instructions for Use of medical device (in English unless the device has CE mark, when it must be in Czech)

  • Information about Data Protection and patient rights CZ

  • Invoicing details CZ or EN

  • Ethics Committee questionnaire CZ

Sponsor responsibilities:

  • Notice of first patient enrollment – immediately post enrollment CZ
  • Clinical trial report - once a year (within 60 days of the expiry of that period for drug trials and before 31 January of the following year for device trials) The report or a summary of the report to be submitted in the Czech language, or a report in English can be submitted accompanied by the Annual/ Close out report form (see Documents for downloading)
  • Clinical trial Safety report - once a year CZ
  • Report of a serious unexpected adverse event which results in death or is life threatening and which occurs at NNH study centre - within 7 days of the date that the sponsor becomes aware of the event; further detailed information to be submitted within another 8 days CZ
  • Report of a suspected serious unexpected adverse event which occurred in NNH study centre -within 15 days days of the date that the sponsor becomes aware of the event CZ
  • An overview of all Serious Adverse Event / Effect reports – every 3 months CZ or ENG
  • Termination of a study - within 90 days for drug trials or within 30 days for medical device trials CZ
  • Interruption of a study - within 30 days CZ
  • Early termination of a study - within 15 days for drug trials and within 30 days for medical device trial CZ
  • Clinical study report – The report or a summary of the report to be submitted in the Czech language, or a report in English can be submitted accompanied by the Annual/ Close out report form (see Documents for downloading)

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