Case Report Forms and Study Reports Sample Clauses

Case Report Forms and Study Reports. Electronic case report forms (eCRFs) are provided for each patient. All forms must be filled out by authorized study personnel. The Investigator is required to sign/e-sign the eCRF after all data have been captured for each patient. If corrections are made after review and signature by the Investigator, he or she must be made aware of the changes, and his or her awareness documented by re-signing the eCRF.
Sample 1
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Case Report Forms and Study Reports. Electronic case report forms (eCRFs) are provided for each patient. All forms must be filled out by authorized study personnel. The Investigator is required to sign/e-sign the eCRF after all data have been captured for each patient. If corrections are made after review and signature by the Investigator, he or she must be made aware of the changes, and his or her awareness documented by re-signing the eCRF Critical Documents Before ImmunoGen initiates the study at a given site, it is the responsibility of the Investigator to ensure that the following documents are made available to ImmunoGen or their designee: • Curricula vitae of Investigator and sub-Investigator(s) (current, dated and signed or supported by an official regulatory document) • Signed and dated agreement of the final protocol • Signed and dated agreement of any amendment(s), if applicable • Approval/favorable opinion from the IRB/IEC clearly identifying the document and document revision reviewed, including but not limited to, the protocol, any protocol amendments, Investigator Brochure, Patient Information/ICF, and any other written information to be provided regarding patient recruitment procedures • Copy of IRB/IEC approved Patient Information/ICF/any other written information/advertisement • List of IRB/IEC Committee members/constitution or equivalent compliance statement • Study and Financial agreement(s) • Completed Form FDA 1572 or equivalent form • Completed Financial Disclosure Form Additional documents such as laboratory reference ranges and certifications will be collected during the study. Ongoing regulatory approvals and notifications, as required, must also be made available to ImmunoGen.
Sample 1

Related to Case Report Forms and Study Reports

  • Audits No more than once a year, or following unauthorized access, upon receipt of a written request from the LEA with at least ten (10) business days’ notice and upon the execution of an appropriate confidentiality agreement, the Provider will allow the LEA to audit the security and privacy measures that are in place to ensure protection of Student Data or any portion thereof as it pertains to the delivery of services to the LEA . The Provider will cooperate reasonably with the LEA and any local, state, or federal agency with oversight authority or jurisdiction in connection with any audit or investigation of the Provider and/or delivery of Services to students and/or LEA, and shall provide reasonable access to the Provider’s facilities, staff, agents and XXX’s Student Data and all records pertaining to the Provider, LEA and delivery of Services to the LEA. Failure to reasonably cooperate shall be deemed a material breach of the DPA.

  • Amendments This Agreement may not be amended, modified or waived as to any particular provision, except by a written instrument executed by all parties hereto.

  • GRIEVANCE PROCEDURE 7.01 For purposes of this Agreement, a grievance is defined as a difference arising between the parties relating to the interpretation, application, administration or alleged violation of the Agreement including any question as to whether a matter is arbitrable.

  • Background Purchaser wishes to purchase a Revenue Sharing Note issued by the Company through xxx.Xxxxxxxx.xxx (the “Site”).

  • Intellectual Property The Company and the Subsidiaries have, or have rights to use, all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or required for use in connection with their respective businesses as described in the SEC Reports and which the failure to so have could have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). None of, and neither the Company nor any Subsidiary has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired, terminated or been abandoned, or is expected to expire or terminate or be abandoned, within two (2) years from the date of this Agreement. Neither the Company nor any Subsidiary has received, since the date of the latest audited financial statements included within the SEC Reports, a written notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe upon the rights of any Person, except as could not have or reasonably be expected to not have a Material Adverse Effect. To the knowledge of the Company, all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any of the Intellectual Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of all of their intellectual properties, except where failure to do so could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • Dispute Resolution All or any disputes arising out or touching upon or in relation to the terms and conditions of this Agreement, including the interpretation and validity of the terms thereof and the respective rights and obligations of the Parties, shall be settled amicably by mutual discussion, failing which the same shall be settled through the adjudicating officer appointed under the Act.

  • Termination for Convenience TIPS may, by written notice to Vendor, terminate this Agreement for convenience, in whole or in part, at any time by giving thirty (30) days’ written notice to Vendor of such termination, and specifying the effective date thereof.

  • Notices Any notice, request or other document required or permitted to be given or delivered to the Holder by the Company shall be delivered in accordance with the notice provisions of the Purchase Agreement.

  • Introduction The Texas Health and Human Services Commission ("HHSC") and the Contractor named in Section I (HHSC and Contractor may be referenced in this document collectively as the “Parties” and individually as the “Party") hereby enter into this Community Services Contract - Provider Agreement (the “Contract”) for the provision of services under the Contract type specified in Section I for the considerations set forth herein. The Contract Begin Date specified in Section I is not valid until this Contract is signed by both parties.

  • Amendment This Warrant may be modified or amended or the provisions hereof waived with the written consent of the Company and the Holder.

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