Transfer Regulations Definition: 710 Samples | Law Insider hb```,&B Arbitration and mediation case participants and FINRA neutrals can view case information and submit documents through this Dispute Resolution Portal. The Career Education requirement for this Contract is 0 hours. SOPs provide an excellent source for training new employees. <>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 612 792] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> We will comply with your request if it is reasonable and continues to permit us to collect premiums and pay claims under your policy, including issuing certain explanations of benefits and policy information to the BlueShield of Northeastern New York is a division of HealthNow New York Inc., an independent licensee of the BlueCross BlueShield Association. Regulatory bodies require organizations to have formal documentation describing their Business, Quality, and Compliance practices. Any such transfer shall be described in writing. 3 0 obj Documentation and compliance (a) The data importer shall promptly and adequately deal with enquiries from the data exporter that relate to the processing under these Clauses. Instructions for Downloading Viewers and Players. Non-exempted capital assets shall be transferred or permanently disposed of strictly in accordance with Chapter 2 of the Municipal Asset Transfer Regulations. Submit the scope of work from the contract with the 1571. In the event of any payment by the Secondary Indemnitors of amounts otherwise required to be indemnified or advanced by the Company under the Companys certificate of incorporation or bylaws or this Agreement, the Secondary Indemnitors shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee for indemnification or advancement of expenses under the Companys certificate of incorporation or bylaws or this Agreement or, to the extent such subrogation is unavailable and contribution is found to be the applicable remedy, shall have a right of contribution with respect to the amounts paid. GCP is a bit broader (again, emphasis mine): 5.2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. We may ask that you submit a written, signed authorization form permitting us to do so and we may charge a reasonable fee for copying and mailing your personal information. whether wholesale market makers are conducting adequate execution quality reviews;, whether order routing, handling and execution arrangements (including PFOF agreements) with retail broker-dealers have an impact on the wholesale marker makers order handling practices and decisions, and fulfillment of their best execution obligations; and. For example, if a family member calls us with prior knowledge of a claim (e.g., providers name, date of service, etc. The specific obligations transferred by Sponsor to CTI in any particular Study will be detailed in the relevant Work Standard Operating Procedures Compliance Review During the Term, Developer agrees to permit the GLO, HUD, and/or a designated representative of the GLO or HUD, to access the Property for the purpose of performing Compliance Monitoring Procedures. SOP In furtherance of the activities contemplated by this Agreement, Novartis and Novartis AG each shall, or shall cause its Affiliates to, transfer to Vanda the IND, including copies of all relevant registration dossiers. Inspection; Compliance Lessor and Lessor's Lender(s) (as defined in Paragraph 8.3(a)) shall have the right to enter the Premises at any time, in the case of an emergency, and otherwise at reasonable times, for the purpose of inspecting the condition of the Premises and for verifying compliance by Lessee with this Lease and all Applicable Laws (as defined in Paragraph 6.3), and to employ experts and/or consultants in connection therewith and/or to advise Lessor with respect to Lessee's activities, including but not limited to the installation, operation, use, monitoring, maintenance, or removal of any Hazardous Substance or storage tank on or from the Premises. MEETING CRO-VENDOR OVERSIGHT REQUIREMENTS Regulatory SEC.gov UCLA. Request confidential communications You can ask us to contact you in a specific way (for example, home or office phone) or to send mail to a different address. WebIt is Transfer of Regulatory Obligations. In any such case, Lessee shall upon request reimburse Lessor or Lessor's Lender, as the case may be, for the costs and expenses of such inspections. We will consider all reasonable requests, and must say yes if you tell us you would be in danger if we do not. Sec. The costs and expenses of any such inspections shall be paid by the party requesting same, unless a Default or Breach of this Lease, violation of Applicable Law, or a contamination, caused or materially contributed to by Lessee is found to exist or be imminent, or unless the inspection is requested or ordered by a governmental authority as the result of any such existing or imminent violation or contamination. For clinical trials specifically, SOPs ensure that the research conducted within clinical sites adheres to the Federal regulations, ICH-GCP, and institutional policies to safeguard the human study participants' welfare and rights. - Our Responsibilities This notice describes how medical information about you may be used and disclosed and how you can get access to this information. A Player playing in a Match under an Interchange Agreement as detailed at clause 3.9 of the National Player Transfer Regulations (i.e. Report a concern about FINRA at 888-700-0028, Securities Industry Essentials Exam (SIE), Financial Industry Networking Directory (FIND), 2022 Report on FINRAs Examination and Risk Monitoring Program, Outside Business Activities and Private Securities Transactions, Firm Short Positions and Fails-to-Receive in Municipal Securities, Funding Portals and Crowdfunding Offerings, Segregation of Assets and Customer Protection, AppendixUsing FINRA Reports in Your Firms Compliance Program, Best Execution Outside-of-the-Inside Report Card. The SOP also identifies ". endstream endobj startxref Document #: SOP-000051 . Sponsors take different approaches to satisfying these requirements: 1. City Responsibilities 2.8.1 CITY shall make available to CONSULTANT all technical data that is in CITY'S possession, reasonably required by CONSULTANT relating to the SERVICES. Such procedures shall include all requirements in this subpart. : transfer of Sponsor IND obligations Study Name ind # XYZ Co. wishes to transfer some of its obligations as IND Sponsor under 21CFR 312. WebTransfer of Obligations can go either way depending on who is holding the IND. Compliance Investigations Upon the City's request, the Design Professional agrees to provide to the City, within sixty calendar days, a truthful and complete list of the names of all Subcontractors, vendors, and suppliers that the Design Professional has used in the past five years on any of its contracts that were undertaken within San Diego County, including the total dollar amount paid by the Design Professional for each subcontract or supply contract. The Design Professional further understands and agrees that the procedures, remedies and sanctions provided for in the Nondiscrimination Ordinance apply only to violations of said Nondiscrimination Ordinance. Transfer Ask us to correct health and claims records You can ask us to correct your health and claims records if you think they are incorrect or incomplete. As always, lets start with the regulation (emphasis mine): 21 CFR 312.52 Transfer of obligations to a contract research organization. Transfer of Regulatory Obligations listed as TORO Transfer of Regulatory Obligations - How is Transfer of Regulatory They provide a method to compare quality to, document an organizations missions and values, and serve as a reference for the employee. xkZL hSO* h 5OJ QJ ^J hA* h CJ OJ QJ ^J aJ hA* h OJ QJ ^J ho hG *h_ hU Q *hU Q *hU Q 5 *ht hU Q 5 *ht hU Q hU Q hO_ hU Q h} hU Q 5hU Q 5CJ OJ QJ ^J aJ &hj hU Q 5;CJ OJ QJ ^J aJ hU Q 5;CJ OJ QJ ^J aJ &h/) hU Q 5;CJ OJ QJ ^J aJ $ / 5 W A 4. Web 312.52 Transfer of obligations to a contract research organization. Agency Responsibilities Agency is responsible for (a) Agencys use of Axon Devices; (b) breach of this Agreement or violation of applicable law by Agency or an Agency end user; and (c) a dispute between Agency and a third-party over Agencys use of Axon Devices. The Design Professional further agrees to fully cooperate in any investigation conducted by the City pursuant to the City's Nondiscrimination in Contracting Ordinance (San Diego Municipal Code sections 22.3501-22.3517) The Design Professional understands and agrees that violation of this clause shall be considered a material breach of the contract and may result in remedies being ordered against the Design Professional up to and including contract termination, debarment, and other sanctions for violation of the provisions of the Nondiscrimination in Contracting Ordinance. eCFR :: 21 CFR 312.52 -- Transfer of obligations to a If CIT/VC elects to transfer Securities of the Company to a Regulated Holder in order to avoid a Regulatory Problem, the Company shall enter into such agreements with such Regulated Holder as it may reasonably request in order to assist such Regulated Holder in complying with applicable laws, and regulations to which it is subject. > y+ bjbj~~ p { { $" T 3 3 3 3 3 $ W W W P L , W : L k k k 4 4 4 3: 5: 5: 5: 5: 5: 5: , h. The Transfer of Obligations Form will be filed with the Food and Drug Administration (FDA) by Sponsor where appropriate, or as required by law or regulation. FINRA is conducting targeted best execution reviews of wholesale market makers concerning their relationships with broker-dealers that route orders to them as well as their own order routing practices and decisions (with respect to these orders). 8(z-!vA< Kh`h`h@V4Y,HcyrU CMa?Bj s4#aPnlH10E3!j ,& Exempted capital assets shall be transferred strictly in accordance with Chapter 3 of the Municipal Asset Transfer Regulations. In general, unless we obtain your written authorization, we will only disclose such information as provided for in applicable laws. Manual or automatic displays of the current status of position 21 CFR 11 requires organizations to have policies, procedures, and work instructions, including: System backup & recovery (21CFR 11.10(c)), Business continuity (disaster recovery) (21CFR 11.10(c)), Granting system access & computer system security (21CFR 11.10(d).100, .200, 300), Training & training documentation (21CFR 11.10(i)), Use of electronic signatures (21CFR 11.10(j)), System operation and maintenance (21CFR 11.10(k)(l)), 21 CFR 312.53: The investigator will "ensure that all associates, colleagues, and employees assisting in the conduct of the study (ies) are informed of their obligations in meeting the above commitment. ( a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract Any such transfer shall be described in writing. WebSOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. My preferred method is #2: list vendors in the 1571 and provide the scopes of work. If you discover something that infringes any law, please let us know, and well review it. For the purposes of this document, XYZ Co. will be the transferor and UCSF the transfereeSponsor IND Obligations Under 21 CFR Part 312 Investigational New Drug (IND) Application 21 CFR 312.50 General Responsibilities of SponsorsEnsuring that the investigation is conducted in accordance with the general investigational plan and protocols, as referenced in 21 CFR 312.50;BothMaintaining an effective IND with respect to the investigations, as referenced in 21 CFR 312.50;XYZ Co.Ensuring that Food and Drug Administration (FDA) and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug, as referenced in 21 CFR 312.50.XYZ Co. 21 CFR 312.53 Selecting Investigators and MonitorsSelecting qualified investigators, as referenced in 21 CFR 312.53(a);UCSFControlling the shipment of investigational test article, as referenced in 21 CFR 312.53(b);XYZ Co.Qualifying the investigators by obtaining required information and commitments, as referenced in 21 CFR 312.53(c);UCSFSelecting monitors, as referenced in 21 CFR 312.53(d).XYZ Co. 21 CFR 312.55 Informing InvestigatorsProviding an investigator brochure, as referenced in 21 CFR 312.55(a);XYZ Co.Informing investigators of new observations discovered by or reported to the sponsor, particularly with respect to adverse effects and safe use, as referenced in 21 CFR 312.55(b).XYZ Co. 21 CFR 312.56 Review of Ongoing InvestigationsReviewing ongoing investigations, as referenced in 21 CFR 312.56 to include one or more of the following:Monitoring all clinical investigations, as referenced in 21 CFR 312.56(a);XYZ Co. File a complaint if you feel your rights are violated You can complain if you feel we have violated your rights by contacting us using the information listed on page 4. Web(a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. SOPs Help Maintain Operational Efficiencies Remittance transfer pr oviders must provide the disclosures in English, and sometimes also in other languages, as discussed in Section 4.1. WebModule 1.3.1.4 Transfer of Obligations Pfizer Confidential 1 TRANSFER OF OBLIGATIONS In compliance with 21 CFR 312.52, Table 1 below lists the Sponsor responsibilities* that were transferred from BioNTech SE to Pfizer Inc. in the conduct of the C4591001 clinical study, with the specific obligations that were transferred. In conducting its Compliance Review, the GLO and HUD will rely primarily on information obtained from Developers records and reports, findings from on-site monitoring, and audit reports. This is the letter-of-the-law approach to the regulation that results in a form that enumerates only responsibilities in Subpart D as they are worded in Subpart D, e.g.. Pros: Fulfills the requirement while limiting the amount of information FDAhas at least until the inspection. PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION, Subpart D - Responsibilities of Sponsors and Investigators. Transfer of Obligations If any sponsor or investigator responsibilities are transferred to another organization, include this formal agreement and any related In the event that CIT/VC determines that it has a Regulatory Problem, the Company agrees to use commercially reasonable efforts to take all such actions as are reasonably requested by CIT/VC in order (A) to effectuate and facilitate any transfer by CIT/VC of any Securities of the Company then held by CIT/VC to any Person designated by CIT/VC (subject, however, to compliance with Section 3 of this Agreement), (B) to permit CIT/VC (or any Affiliate of CIT/VC) to exchange all or any portion of the voting Securities of the Company then held by such Person on a share-for-share basis for shares of a class of non-voting Securities of the Company, which non-voting Securities shall be identical in all respects to such voting Securities, except that such new Securities shall be non-voting and shall be convertible into voting Securities on such terms as are requested by CIT/VC in light of regulatory considerations then prevailing, and (C) to continue and preserve the respective allocation of the voting interests with respect to the Company arising out of CIT/VC's ownership of voting Securities of the Company and/or provided for in this Agreement before the transfers and amendments referred to above (including entering into such additional agreements as are requested by CIT/VC to permit any Person(s) designated by CIT/VC to exercise any voting power which is relinquished by CIT/VC upon any exchange of voting Securities for nonvoting Securities of the Company); and the Company shall enter into such additional agreements, adopt such amendments to this Agreement, the Company's Charter and the Company's By-laws and other relevant agreements and taking such additional actions, in each case as are reasonably requested by CIT/VC in order to effectuate the intent of the foregoing. 21 CFR 211.100 Written Procedures; Deviations How does your firm handle fractional share investing in the context of its best execution obligations? We do not generate, modify, or maintain complete medical records. October 18, 2018 Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations ( CROs). The CRO should implement quality assurance and quality control. You shall not (a) make the Services available to anyone other than Users, (b) sell, resell, rent or lease the Services, (c) use the Services to store or transmit infringing, libelous, or otherwise unlawful or tortious material, or to store or transmit material in violation of third-party privacy rights, (d) use the Services to store or transmit Malicious Code, (e) interfere with or disrupt the integrity or performance of the Services or third-party data contained therein, or (f) attempt to gain unauthorized access to the Services or their related systems or networks. WebAny responsibilities not specifically transferred in the Transfer of Obligations Form shall remain the regulatory responsibility of Sponsor. TORO! - Ready Room TRANSFER OF SPONSOR IND OBLIGATIONS Cons: Potential for inconsistency during transcription; need to create a new form every time the scope changes. Summarize transferred responsibilities at a high level in the 1571 submission, referencing the contract as the governing transfer of obligations. Borrower is not engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). %PDF-1.5 Are SOPs really important - Not only to plan consistent manufacturing or testing operations repeatedly but also to ensure that your Quality Control (QC), Quality Assurance (QA), and production units use them to assure the accuracy of the original product development? The University will retain ultimate responsibility for the education of its students. Most comprehensive library of legal defined terms on your mobile device, All contents of the lawinsider.com excluding publicly sourced documents are Copyright 2013-, Development Regulatory Approvals and Marketing, Product Removals, Corrections and Recalls, OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Later, we contracted the same CRO as our clinical CRO. WebClinical investigators initiating a drug study invoke a number of specific regulatory requirements beyond those mandated for protection of human subjects in clinical trials.1These regulatory requirements for drug studies address the safety and efficacy issues unique to the use of pharmaceuticals in the clinical research setting. The three key procedural documentation types include policies, procedures (SOPs), and work instructions. Compliance Overview: Standard Operating Procedures Primary Responsibility The Company acknowledges that to the extent Indemnitee is serving as a director on the Companys board of directors at the request or direction of a venture capital fund or other entity and/or certain of its affiliates (collectively, the Secondary Indemnitors), Indemnitee may have certain rights to indemnification and advancement of expenses provided by such Secondary Indemnitors. (b) A contract research organization that assumes any obligation of a sponsor shall comply with the specific regulations in this chapter applicable to this obligation and shall be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations. Guideline Sponsors Responsibilities IMP handling and 15049R_NENY_12_19 f11011 subscriber of the policy. Additional filters are available in search. 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