Retention of the Documents. The investigator agrees to retain all study related documentation in secure, fire retardant storage, for at least 2 years after the last approval of a marketing application (and there are no pending or contemplated applications), or at least 2 years after clinical development of the medication has been terminated. If local regulations require a longer period of retention, then these will take precedence. YM will inform the investigator when retention of trial documents is no longer required.
Retention of the Documents. The Institution agrees to retain all Study related documentation, including but not limited to all Study Data and Trial Subjects clinical notes, hospital records and other relevant Trial Subject information, in secure storage, for such period as required by applicable law (“Record Retention Period”). Pharm-Olam and/or Sponsor are entitled to inspect the records at any time during the period of record retention, upon reasonable advance notice. The Institution must further ensure that all Study related documentation is stored on media such that they remain complete and legible throughout the required period of retention. The Institution shall notify the Sponsor in writing at least sixty (60) days prior to the end of the Record Retention Period and, as may be required by Sponsor at that time, the Institution and/or Investigator will ship the records to another facility for storage, at the Sponsor’s direction. If the Institution becomes unable for any reason to continue to retain the records for the Record Retention Period, Pharm-Olam and Sponsor should be notified immediately. Investigator shall store, keep and maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the Trial 7. Držení dokumentů Zdravotnické zařízení souhlasí s uchováváním veškeré dokumentace vztahující se ke Studii mimo jiné veškerých Studijních dat, klinických záznamů Subjektů hodnocení, nemocničních záznamů a dalších relevantních informací o Subjektech hodnocení v zabezpečeném archivu po dobu, která je vyžadována platnými právními předpisy (xxxx xxx „Doba uchovávání záznamů“). Pharm-Olam a/nebo Zadavatel jsou oprávněni ke kontrole záznamů kdykoliv v průběhu xxxx uchovávání, po předchozím oznámení, učiněném v přiměřené době. Zdravotnické zařízení xxxx xxxx zajistit, že veškerá dokumentace vztahující se ke Studii bude uchovávána na takovém médiu, že bude zajištěna jejich úplnost a čitelnost po celou vyžadovanou dobu uchovávání. Zdravotnické zařízení se zavazuje písemně oznámit Zadavateli nejméně šedesát (60) dnů před uplynutím Xxxx uchovávání záznamů, a jak může být v xx xxxx požadováno Zadavatelem, skutečnost, že Zdravotnické zařízení a/nebo Zkoušející zašle záznamy podle pokynu Zadavatele pro účely skladování do jiného zařízení. Pokud se Zdravotnické zařízení ocitne z jakéhokoli důvodu v pozici, kdy nemůže nadále záznamy po Dobu uchovávání záznamů uchovávat, bude o xxx ihned informovat společnost Pharm-Olam a Zadavatele. Zkoušejí...
Retention of the Documents. The Institution agrees to retain all Study related documentation, including but not limited to all Study Data and Trial Subjects clinical notes, hospital records and other relevant Trial Subject information, in secure storage, for such period as required by applicable law (“Record Retention Period”). Pharm-Olam and/or Sponsor are entitled to inspect the records at any time during the period of record retention, upon reasonable advance notice. The Institution must further ensure that all Study related documentation is stored on media such that they remain complete and legible throughout the required period of retention. The Institution shall notify the Sponsor in writing at least sixty (60) days prior to the end of the Record Retention Period and, as may be required by Sponsor at that time, the Institution and/or Investigator will ship the records to another facility for storage, at the Sponsor’s direction. If the Institution becomes unable for any reason to continue to retain the records for the Record Retention Period, Pharm-Olam and Sponsor should be notified immediately.
Retention of the Documents. The Institution agrees to retain all Study related documentation, including but not limited to all Study Data and Trial Subjects clinical notes, hospital records and other relevant Trial Subject information, in secure storage, for such period as required by applicable law (“Record Retention Period”). Pharm-Olam and/or Sponsor are entitled to inspect the records at any time during the period of record retention, upon reasonable advance notice. The Institution must further ensure that all Study related documentation is stored on media such that they remain complete and legible throughout the required period of retention. The Institution shall notify the Sponsor in writing at least sixty (60) days prior to the end of the Record Retention Period and, as may be required by Sponsor at that time, the Institution and/or Investigator will ship the records to another facility for storage, at the Sponsor’s direction. If the Institution becomes unable for any reason to continue to retain the records for the Record Retention Period, Pharm-Olam and Sponsor should be notified immediately. Investigator shall store, keep and maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the Trial subjects and shall ensure that source data shall be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data (including electronic health records) shall be traceable, shall not obscure the original entry and shall be explained by Investigator without undue delay if deemed necessary by Sponsor.
