DOCUMENTATION OF STUDY RESULTS Sample Clauses

DOCUMENTATION OF STUDY RESULTS. All required information must be entered in the CRFs provided to record data for each subject. If an item is not available or is not applicable, this fact should be indicated and no blank spaces must be left. The data collected in the CRF will be entered into the study database. If the Investigator authorizes other personnel to enter data into the CRF, the names, positions, signatures, and initials of these persons must be supplied to Sobi AG or their authorized representative before these individuals start completing CRF information. The CRF pages must be reviewed and signed by the Investigator named in the study protocol or by a designated sub-investigator. Sobi AG will ensure that the CRF copies left with the Investigator (print- outs and/or CD-ROM) have never been under the direct or indirect control of Sobi AG.
Sample 1
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DOCUMENTATION OF STUDY RESULTS. An electronic CRF is used in this study and a specific electronic CRF will correspond to each subject. All required information must be entered on the CRFs. If an item is not available or is not applicable, this fact should be indicated and no blank spaces must be left. The data collected on the CRF will be entered into the study database. If the investigator authorises other personnel to enter data into the CRF, the names, positions, signatures, and initials of these persons must be supplied to NovImmune or their authorised representative before these individuals start completing CRF information. The CRF pages must be reviewed and signed by the Investigator named in the study protocol or by a designated sub-investigator. NovImmune will ensure that the CRF copy left with the Investigator (print- outs and/or CD-ROM) has never been under the direct or indirect control of NovImmune.
Sample 1

Related to DOCUMENTATION OF STUDY RESULTS

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • Regulatory Filing In the event that this Interconnection Construction Service Agreement contains any terms that deviate materially from the form included in Attachment P or from the standard terms and conditions in this Appendix 2, the Transmission Provider shall file the executed Interconnection Construction Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Dissemination of Research Findings and Acknowledgement of Controlled-Access Datasets Subject to the NIH GDS Policy It is NIH’s intent to promote the dissemination of research findings from use of controlled-access dataset(s) subject to the NIH GDS Policy as widely as possible through scientific publication or other appropriate public dissemination mechanisms. Approved Users are strongly encouraged to publish their results in peer-reviewed journals and to present research findings at scientific meetings.

  • Medical Documentation The teacher must supply a letter from a medical 3 doctor, who treated the patient, stating that in his/her opinion, there is a strong 4 probability that the illness was contracted at school.

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

  • Documentation and Record Keeping 1. Records to be Maintained Subrecipient shall maintain all records required by the Federal regulations specified in 24 CFR 570.506 that are pertinent to the activities to be funded under this Contract. Such records shall include, but not be limited to:

  • Technical Documentation Prior to commencement of the Tests on Completion, the Contractor shall supply to the Engineer the technical documentation as specified in the Employer’s Requirements. The Works or Section shall not be considered to be completed for the purposes of taking- over under sub-clause 10.1 [Taking Over of the Works and Sections] until the Engineer has received the technical documentation as defined in this sub-clause 5.7, the "history file" including design calculations and certain certification as well as any other documents required to meet the CE Marking requirements.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

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