Trial Data definition
Trial Data shall include, without limitation, Research Data, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries.
Trial Data shall include, without limitation, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. „Data klinického hodnocení“ zahrnují mimo jiné CRF (či jejich ekvivalent) nebo elektronické záznamy dat, jakož i veškeré další dokumenty či materiály vytvořené pro hodnocení, a u nichž je požadováno, aby byly předloženy zadavateli nebo CRO nebo jakémukoli dodavateli třetí strany instruovaným zadavatelem, jako jsou rentgenové snímky, snímky magnetické rezonance nebo jiné typy lékařských snímků, EKG, EEG či jiné typy sledování či výtisků nebo souhrny dat. “Trial Subject” shall mean a patient participating in the Trial. „Subjekt klinického hodnocení“ znamená pacienta účastnícího se klinického hodnocení.
Trial Data means all data (together with all clinical trial reports and the results of analyses thereof) derived or generated in the Ongoing Trial or the Extension Study by or on behalf of Novartis or its Affiliate, to the extent transferable to Pharming under this Agreement in accordance with Applicable Law.
Examples of Trial Data in a sentence
Medical records relating to Trial Subjects that are not submitted to Sponsor may include some of the same information as is included in Trial Data; however, Sponsor makes no claim of ownership to those documents or the information they contain.
Institution and/or Principal Investigator will promptly resolve any discrepancies that are identified between the Trial Data and the Trial Subject’s medical records.
Permitted uses and disclosures of Trial Data are described in Section 15 (Publications) of this Agreement.
Institution and Principal Investigator will ensure accurate and timely collection, recording, and submission of Trial Data.
For Confidential Information other than Trial Data (hereinafter defined) and Biological Samples (hereinafter defined) analysis data, these obligations of nonuse and nondisclosure survive termination of this Agreement and continue for a period of five (5) years after termination.
More Definitions of Trial Data
Trial Data means case record forms and related material (including copies of correspondence, hospital and clinic notes and discharge summaries, relevant information from telephone conversations and site visits) on individual participants received from the Centres and laboratory results obtained from the laboratories participating in the Phase III Clinical Trial. All such data will be anonymous;
Trial Data means all labora- tory and clinical data, primary and summary, that are generated with respect to the Trial, including case report forms, safety infor- mation, informed consent forms and Principal Investigator’s study notebooks, excluding any original Subject medical records that are con-
Trial Data means all personal data relating to any Data Subject collected by Provider or Provider Representatives or both. Provider and Provider Representatives are processing personal data on behalf of the controller which is Company and are therefore individually and collectively referred to as "Processor". Processor will comply, at their expense, with GDPR and all Applicable Laws, as amended from time to time, with respect to the Processing of Trial Data, and with the following provisions.
Trial Data means all laboratory and clinical data, primary and summary, that are generated with respect to the Trial, including case report forms, safety information, informed consent forms and Principal Investigator’s study note- books, excluding any original Subject medical records that are considered “Source Docu- ments” (as defined by International Conference on Harmonization (ICH) Guidance E6 “Good Clinical Practice”). Evropské lékové agentury a jejího případného nástupnického orgánu („EMEA“) a Úřadu USA pro kontrolu potravin a léčiv a jeho případného nástupnického orgánu („FDA“) a v plném souladu s Protokolem a s Právními předpisy. „Údaje o klinickém hodnocení“ znamenají veškeré pr- votní i souhrnné laboratorní a klinické údaje vy- produkované ve vztahu ke Klinickému hodnocení, včetně formulářů lékařských záznamů o pacien- tech, bezpečnostních informací, formulářů infor- movaných souhlasů a studijních poznámek Hlav- ního zkoušejícího a s výjimkou veškerých originá- lů zdravotních záznamů Subjektů, které jsou pova- žovány za „Zdrojové dokumenty“ (dle definice Směrnice E6 Mezinárodní konference o harmoni- zaci (ICH) „Správná klinická praxe“).
Trial Data shall include, without limitation, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. „Data klinického hodnocení“ zahrnují mimo jiné CRF (či jejich ekvivalent) nebo elektronické záznamy dat, jakož i veškeré další dokumenty či materiály vytvořené pro hodnocení, a u nichž je požadováno, aby byly předloženy zadavateli nebo CRO nebo jakémukoli dodavateli třetí strany instruovaným zadavatelem, jako jsou rentgenové snímky, snímky magnetické rezonance nebo jiné typy lékařských snímků, EKG, EEG či jiné typy sledování či výtisků nebo souhrny dat.
Trial Data means the formatted data sets containing the patient data reported by Investigators on case report forms and data queries".
Trial Data shall include, without limitation, Research Data, CRFs (or their equivalent) or electronic data records, as well as any other documents or materials created for the Trial and required to be submitted to Sponsor or the CRO or any other third party vendor instructed by Sponsor, such as X-ray, MRI, or other types of medical images, ECG, EEG, or other types of tracings or printouts, or data summaries. 1.22 “Trial Subject” shall mean a patient participating in the Trial. 2 PI, Sub-Investigators and Research Staff 2.1 PI is an employee of Institution and shall be responsible for the direction of the Trial in accordance with Applicable Law, the Protocol, Sponsor’s instructions, IEC approval and Institution’s applicable policies. Institution may not appoint any other person as PI without Sponsor’s prior written approval. PI shall provide Sponsor and/or CRO with a written statement about his/her possible economic or other interests in connection with the performance of the Trial and Trial preparations (financial disclosure) upon the Effective Date. If PI is unable to perform the duties required under this Agreement, Institution and PI shall promptly notify the Sponsor in writing. If a replacement acceptable to the Sponsor is not available, this Agreement may be terminated as provided in Section 20.1.e) of this Agreement. 1.18 „Produkt Zadávateľa“ znamená produkt Zadávateľa, ktorý sa v Skúšaní skúma. Ak sa Produkt Zadávateľa skúma v Skúšaní v kombinácii s iným produktom, „Produkt zadávateľa“ znamená ich kombináciu. 1.19 „Odškodnené osoby Zadávateľa” majú význam, aký sa uvádza v Článku 19.1. 1.20 „Skúšanie” znamená multicentrické klinické skúšanie, ktoré sa má realizovať v súlade s Protokolom.