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Estonia – Regulation 23 - Conducting Clinical Trials(4) If the trial is terminated as planned, the principal investigator shall notify the agencies specified in subsection (3) and the ethics committee thereof within 90 calendar days. §13. Entry into force of Regulation This Regulation enters into force on 1 March 2005.Annex 1  [1] Append the EudraCT number confirmation receipt. [2] Any translation of the protocol should be assigned the same date and version as those in the original document. [3] International Standard Randomised Controlled Trial Number. Sponsors may wish to use an International Standardised Random Controlled Trial Number (ISRCTN) to identify their trial in addition to the EudraCT number; for instance if their trial is part of a multinational trial with sites outside the Community. They can obtain the number and guidance from the Current Controlled Trials website http://www.controlled-trials.com/isrctn to which there is a link from the EudraCT database website http://www.eudract.emea.eu.int. When available they should provide it in Section A.6 of the application form. [4] For a resubmission following previous withdrawal of an application or unfavourable opinion of an ethics committee, or previous withdrawal of an application or refusal of a request by the competent authority, enter a letter in the sequence, A for first resubmission, B for second, C for third et seq. [5] In accordance with Article 19 of Directive 2001/20/EC. Annex 2 Annex 3 Annex 4 Annex 5
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