Study Data. For each Study, the Institution and the applicable Principal Investigator acknowledge and agree that the data collected during the Study (“Study Data”), except as otherwise provided in Section 15.8, is owned by SPONSOR. SPONSOR may use all Study Data collected during the Study for any and all purposes at the sole discretion of SPONSOR, provided it is consistent with Applicable Laws and regulations, this Agreement and the informed consent form signed by the Subject. Study Data is confidential, and Institution agrees that premature disclosures of the data may be misleading. If the Study is a Multi-Center Study, then after the completion, or earlier termination, of the Study at all participating sites, SPONSOR shall conduct, or cause to be conducted, such analyses of the data resulting from each site participating in the Multi-Center Study (“Multi-Center Study Analyses”) and, if requested, deliver the results of such analyses (“Multi-Center Study Results”) to the applicable Principal Investigator together with the underlying data relating only to Subjects enrolled in the Study at the Institution (“Site Data”), but not any other data and databases that are supplied, prepared, collected, developed or generated as a result of, in the performance of, or in connection with the Multi-Center Study at non Institution sites (“Multi-Center Study Data”). Further, for a Multi-Center Study, the SPONSOR, or its designee, shall have the right to coordinate one or more publications of the Multi-Center Study Results (each, a “Publication”). In case the Study is being conducted solely at the Institution, the SPONSOR will make the data available to the applicable Principal Investigator at the completion or earlier termination of the Study. Any access by Institution and/or its Principal Investigator to the Study Data from all Study sites for Institution and/or Principal Investigator will be addressed in the Study SOW.
Study Data. During the course of the Study, Principal Investigator has agreed to collect certain data, and submit it to CRO, Pfizer or Pfizer’s agent (“Study Data”) as specified in the protocol. Study Data may include Personal Data of Study Subjects. Principal Investigator will ensure accurate and timely collection, recording, and submission of Study Data, including adhering to timelines for data entry set out in the CRF Completion Requirements document provided to Principal Investigator by CRO or Pfizer. Institution will cooperate with Principal Investigator if and as needed to facilitate compliance by Principal Investigator with this obligation. a.
Study Data. Institution and Investigator shall record and maintain complete medical records (including, without limitation, case report forms, laboratory work sheets and reports, and all relevant source documents) generated as a result of conducting the Study (collectively, the “Study Data”) in a timely, accurate, complete and legible manner in the form described in the Protocol. (a)
Study Data. During the course of the Study, Principal Investigator has agreed to collect certain data, as specified in the Protocol, and submit it to CRO, Pfizer or Pfizer’s agent (“Study Data”). Principal Investigator will ensure accurate and timely 11.1 Údaje klinického hodnocení. Hlavní zkoušející souhlasí, že během klinického hodnocení shromáždí určité údaje tak, jak jsou tyto definovány v protokolu, a předloží je CRO, společnosti Pfizer nebo zástupci společnosti Pfizer (dále jen „údaje klinického hodnocení“). Hlavní collection, recording, and submission of Study Data, including adhering to timelines for data entry set out in the CRF Completion Requirements document provided to Principal Investigator by CRO or Pfizer. Institution will cooperate with Principal Investigator if and as needed to facilitate compliance by Principal Investigator with this obligation. zkoušející zajistí včasné shromáždění, zaznamenání a předložení údajů klinického hodnocení, včetně dodržování časového harmonogramu zadávání údajů stanoveného v dokumentu Požadavky na vyplnění záznamu subjektu hodnocení, který hlavnímu zkoušejícímu poskytne CRO nebo společnost Pfizer. Zdravotnické zařízení bude podle potřeby spolupracovat s hlavním zkoušejícím a tak usnadní dodržení tohoto závazku hlavního zkoušejícího.
Study Data. COMPANY shall own all right, title, and interest in and to all Study Data, and all reports and biological or chemical specimens generated by METRICS as a result of conducting the Services. All Study Data and any information with respect thereto shall be COMPANY Confidential Information subject to the confidentiality provisions of Section 5.
Study Data. All information resulting from the Study conducted under this Agreement, including all data (including Subject-level data), results, and conclusions based on such data and/or results (hereinafter “Study Data”) shall be owned exclusively by MSK.
Study Data. During the course of the Study, Principal Investigator will collect certain data, as specified in the Protocol, and submit it to CRO, Pfizer or Pfizer’s agent (“Study Data”). Principal Investigator will ensure accurate and timely collection, recording, and submission of Study Data, including adhering to timelines for data entry set out in the CRF Completion Requirements document provided to Principal Investigator by CRO or Pfizer. 11.1 Studijní údaje studie. Během studie shromáždí Hlavní zkoušející určité údaje uvedené v Protokolu, a předloží je CRO, společnosti Pfizer nebo zástupci společnosti Pfizer (dále jen „Studijní údaje “). Hlavní zkoušející zajistí včasné shromáždění, zaznamenání a předložení Studijních údajů, včetně dodržování časového harmonogramu zadávání údajů stanoveného v dokumentu Požadavky na vyplnění Záznamníku subjektu hodnocení, který Hlavnímu zkoušejícímu poskytne CRO nebo společnost Pfizer.
Study Data. The Institution and Investigator agree to record all Study Data (including, without limitation, CRFs or eCRF’s, laboratory work sheets, slides and reports) generated as a result of conducting the Study (collectively, the “Study Data”) in a timely, accurate, complete, and legible manner in the form described in the Protocol and in compliance with all applicable laws and regulations. The Investigator shall take reasonable and customary precautions, including periodic backup of computer files, to prevent the loss or alteration of any Study Data. Investigator shall ensure that all information entered into the CRFs (or eCRFs) shall reflect the Trial Subject’s true condition. The Investigator shall review all CRFs (or eCRFs) and check the data against all pertinent information in the Trial Subjects clinical records for accuracy and completeness of information, legibility of entries, correct any erroneous data, record use of concomitant drugs, report Adverse Events, concurrent illnesses and document reasons for any missing visits or examinations. The Institution and Investigator shall assist Pharm- Olam, Sponsor and/or Pharm-Olam’s or Sponsor’s representatives and Study monitors upon their request, in promptly resolving any discrepancies or errors contained in the CRFs (or eCRFs) and in performing random audits on Trial Subjects’ records, laboratory reports, or other raw data sources underlying the data recorded on the CRFs (or eCRFs). During the Study, Pharm-Olam, or its representatives shall have the right upon prior notice and during normal business hours to review and verify and at times, to the extent allowed by law, copy (only pseudonymized or anonymized data), all Study Data including, without limitation, original reports of laboratory tests and examination findings, and all other notes, charts, reports, electronic health records or memoranda relating to Trial Subjects enrolled in the Study. In addition, during the Study and for a reasonable period (at least 5 years) following the completion of the Study, Pharm-Olam, Sponsor or their representatives shall have the right to review Trial Subject medical records or certified copies of any electronic health records relating to the Study only for auditing purposes according to applicable law. No later than ten (10) days after the completion or termination of the Study,
Study Data. All data and other information generated or recorded in the performance of the Services, including any summary information based thereon, shall be referred to herein as the “Study Data.” METRICS shall create and maintain written records of the Study Data and other information related to the performance of the Services in a timely, accurate, complete, and legible manner in the form as agreed between the parties. METRICS shall maintain the [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended. Study Data in compliance with the terms and conditions of this Agreement, the Work Statement, and Applicable Law. METRICS shall maintain the Study Data in a professional manner so as to permit COMPANY to review the Study Data in full without disclosing to COMPANY any third party confidential or proprietary information in any review that COMPANY may perform hereunder. METRICS shall make the Study Data available for COMPANY’s inspection and copying during regular business hours and upon reasonable advance notice, provided that COMPANY or its representative may not audit, copy or inspect such records more than once per calendar year. Promptly upon completion or termination of the Services, METRICS shall transfer to COMPANY all Study Data or, at COMPANY’s request, shall maintain the Study Data. METRICS shall not destroy any Study Data until the earlier of (a) [*] or (b) its receipt of COMPANY’s prior written permission to do so. METRICS may in any event retain one true copy of all Study Data, which it may use solely to comply with its obligations under Applicable Law and this Agreement.
Study Data. During the course of the Study, Principal Investigator has agreed, in her separate Agreement with CRO, to collect certain data and submit it to CRO, Pfizer or Pfizer’s agent (“Study Data”), as specified in the Protocol. Study Data may include Personal Data of Study Subjects. Principal Investigator will ensure accurate and timely collection, recording, and submission of Study Data, including adhering to timelines for data entry set out in the CRF Completion Requirements document provided to Principal Investigator by CRO or Pfizer. Institution will cooperate with Principal Investigator if and as needed to facilitate compliance by Principal Investigator with this obligation. 11.1 Studijní údaje. V samostatné smlouvě uzavření s CRO Hlavní zkoušející souhlasila, že během Studie shromáždí údaje a předloží je CRO, společnosti Pfizer nebo zástupci společnosti Pfizer (dále jen „Studijní údaje“), jak je uvedeno v Protokolu. Studijní údaje mohou obsahovat Osobní údaje subjektů Studie. Hlavní zkoušející zajistí včasné shromáždění, zaznamenání a předložení Studijních údajů, včetně dodržování časového harmonogramu zadávání údajů stanoveného v dokumentu Požadavky na vyplnění záznamu subjektu hodnocení („CRF Completion Requirements“), který Hlavnímu zkoušejícímu poskytne CRO nebo společnost Pfizer. Instituce bude podle potřeby spolupracovat s Hlavním zkoušejícím, a tím napomáhat dodržení tohoto závazku Hlavního zkoušejícího. a.
