Case Report Forms 3 Sample Clauses

Case Report Forms 3. 5.1 The Investigator or his/her designee shall complete Case Report Forms, provided by the Sponsor or ICON and shall submit them within forty eight (48) hours of obtaining the data. The Investigator is in any case responsible for the completion and submission of the Case Report Forms. The Investigator shall be present and give these forms and make available any source documents related to the Study, to representatives of Sponsor or ICON at periodic monitoring visits or otherwise promptly upon request. 3.5.2 The Investigator shall fully assist, in a timely manner, ICON representatives in resolving any discrepancies, errors or missing information in Case Report Forms. The Investigator shall help ICON in conducting audits of original case records, laboratory reports, and/or raw data sources underlying data recorded in the Case Report Forms. Such audits shall be conducted with due regard for patient confidentiality. The Institution and Investigator each understands that failure to resolve discrepancies, errors or missing information in Case Report Forms may result 3.3.3 před vstupem způsobilých účastníků do studie zkoušející se způsobilými účastníky projedná všechny podrobnosti a požadavky protokolu a formuláře souhlasu. 3.4 Získávání pacientů do studie Zkoušející vynaloží maximální úsilí, aby získal pouze způsobilé účastníky, a vědomě do studie nezařadí žádné účastníky, kteří podle jeho nejlepšího odborného úsudku dostatečně nesplňují kritéria stanovená pro způsobilé účastníky. Hlavní zkoušející vynaloží maximální úsilí, aby získal přibližně 10 pacientů. Zvýšení počtu pacientů, kteří xxxx být do studie zařazeni, vyžaduje písemné schválení zadavatelem, nikoli však dodatek k této smlouvy. 3.5
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