List of documents for approval of a clinical trial
Written request (cover letter) to discuss the clinical trial with the exact name of the clinical trial in Czech and English, protocol number (including EudraCT number) and briefly stated goal of the clinical trial
Clinical trial protocol, including any appendices
Summary of the clinical trial protocol in the Czech language
Procedures for the recruitment of evaluation bodies
Case Report Forms (CRFs)
Information for evaluation subjects and Forms of written informed consent in the Czech language, possibly. Information and Form of written consent of the minor subject of evaluation in the Czech language
Information on possible compensation or remuneration provided to evaluation subjects, information on compensation for minor evaluation subjects
Information on the amount, method of securing and maturity of the remuneration or compensation to the examiner and the medical facility
Economic calculation of costs associated with conducting a clinical trial (financial balance sheet of a clinical trial)
The essentials of the agreement between the sponsor, the examiner and, if applicable, medical facility
Proof of compensation or insurance in the event of death or damage to the health of the subject as a result of the clinical trial
Evaluation subject logs
Liability insurance for damage concluded for the examiner and the sponsor - the applicant
Curricula vitae of chief examiners and co-examiners (current originals)
Application for the establishment of LEK and Application for consent to the study of the principal examiner (current original
Affidavit of the Chief Examiner (current original)
Copy Registration of the medical facility from the district office of the principal examiner
A copy of the Certificate from the Czech Medical Chamber of the Chief Examiner
Conditions and method of recruitment of evaluation subjects in acute cases
Information on other centers where the clinical trial is to take place, including the relevant local ethics committees
Request for an opinion of the EC University Hospital in Motol on a clinical trial (send by e-mail)
Contact person or company that pays the invoice - billing information (send by e-mail)
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