Case Report Forms and Study Data. 1.6 Záznamy subjektu hodnocení a Studijní údaje
Case Report Forms and Study Data a) PSI shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) within 5 business days, in an accurate and complete manner, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. To the extent the Study requires completion of electronic Case Report Forms, the Institution and the Investigator shall ensure that they have implemented and maintain appropriate computer security sufficient to protect the confidentiality, integrity and availability of such Study Data in accordance with the Applicable Regulatory Requirements. The Investigator shall not grant unauthorized users access to the electronic data capture (EDC) system used in the Study, and in particular, shall not share or disclose his/her username and/or passwords.
Case Report Forms and Study Data a) PSI shall provide access to the electronic Case Report Forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”) in a timely, true, correct, accurate and complete manner in source documents as defined by ICH GCP, and shall ensure that the Case Report Forms for each Study subject are duly signed and dated. The Institution and the Investigator will be responsible for data entry. Where specifically required for Data Adjudication Committee, data entry should occur within two (2) days of a subject visit. Otherwise data entry should occur within five (5) days of a subject visit. Study Personnel will be expected to respond to any electronic data queries within seven (7) days of their creation.
Case Report Forms and Study Data. 1.6 Záznamové formuláre účastníkov klinického skúšania a údaje skúšania
Case Report Forms and Study Data a) PSI shall provide access to the electronic Case Report Forms to be used and completed by the Investigator to document a Study subject’s
Case Report Forms and Study Data a) The Sponsor shall supply (or if electronic, provide access to) the forms to be used and completed by the Investigator to document a Study subject’s participation in the Study (the “Case Report Forms” or “CRFs”). The Investigator shall record all data generated as a result of conducting the Study (the “Study Data”). Study data should be attributable, legible, contemporaneous, original, accurate, complete, and recorded in a timely, accurate and complete manner, and the Investigator shall ensure that the Case Report Forms for each Study subject are duly signed and dated. The
Case Report Forms and Study Data a) The Investigator shall record all data resulting from the Study (the “Study Data”) in an accurate, legible and complete manner. The Institution acknowledges and agrees that the Sponsor shall own all Study Data and Study results.
Case Report Forms and Study Data. 1.6 Xxxxxx xxxxxxxxxx xxxxxx x Xxxxxxxx xxxxx
Case Report Forms and Study Data. (a) PSI shall supply to the Investigative Site forms to be used and completed by the Investigator to document a Study Subject’s participation in the Study (such forms are referred to as “Electronic Case Report Forms”). The Investigative Site shall ensure that the Investigator reviews all patient Electronic Case Report Forms to assure their accuracy and completeness, and assist PSI and its representatives (including clinical monitors) upon their request in prompt resolution of any discrepancies or errors contained in the Electronic Case Report Forms and in review, verification, inspection and/or auditing of the Study Subjects’ records, laboratory reports, or other raw data sources supporting the data recorded on the Electronic Case Report Forms. The Investigative Site shall ensure that the Investigator signs and dates the Electronic Case Report Forms for each Study Subject. (b) The Investigative Site shall ensure that the Investigator records all data generated as a result of conducting the Study (the “Study Data”) in a timely, accurate, complete, and legible manner in the form described in the Protocol. The Investigative Site shall take reasonable and customary precautions to prevent the loss or alteration of any Study Data. The Investigative Site acknowledges and agrees that the Sponsor shall own all Study Data. 1.5 Záznamy subjektu hodnocení a Údaje Studie. (a) PSI dodá Zdravotnickému zařízení formuláře, které má Hlavní zkoušející používat a vyplnit pro zdokumentování účasti Subjektů hodnocení na Studii (tyto formuláře se nazývají „Elektronické záznamy subjektu hodnocení“). Zdravotnické zařízení zajistí, že Hlavní zkoušející bude prověřovat všechny Elektronické záznamy subjektu hodnocení pacientů, aby zajistil jejich přesnost a úplnost, a bude PSI a jejím zástupcům (včetně klinického dozoru) pomáhat na jejich žádost při urychleném řešení jakýchkoliv nesrovnalostí nebo chyb v Elektronických záznamech subjektu hodnocení a xxx xxxxxx, xxxxxxxxx, xxxxxxxx a (nebo) auditu elektronických záznamů o Subjektech hodnocení, laboratorních hlášení nebo jiných zdrojů nezpracovaných údajů zaznamenaných Záznamech subjektu hodnocení. Zdravotnické zařízení zajistí, že Hlavní zkoušející bude podepisovat a datovat elektronické záznamy subjektu hodnocení, a to pro každý Subjekt hodnocení. (b) Zdravotnické zařízení zajistí, že Hlavní zkoušející bude zaznamenávat veškeré údaje generované v důsledku provádění Studie („Údaje Studie“), a to včas, přesně, úplně a čitelně ve formě ...
