Site-specific Protocol Registration Sample Clauses

Site-specific Protocol Registration. ‌ After obtaining approval from all responsible IRBs/ECs, HPTN study sites must complete protocol registration procedures with the DAIDS PRO. Complete details of the site-specific protocol registration are included in the DAIDS Protocol Registration Manual. Protocol registration is completed for each HPTN study on a site-by-site basis. The registration submission is done by the site directly to the PRO via the DAIDS Protocol Registration System (DPRS). The purpose of these procedures is for DAIDS to confirm regulatory compliance and completeness of site informed consent forms and IRB/EC approval documentation prior to study initiation. If a site encounters problems when submitting protocol registration materials through the DPRS, a CRS can submit protocol registration materials via email to the DAIDS Electronic Protocol Registration (EPR) mailbox at XXX@xxxx-xxx.xxx. The DAIDS Protocol Registration Checklist must accompany EVERY submission made to the DAIDS PRO through the EPR mailbox. Upon obtaining all required IRB/EC approvals, site staff will submit the following documents to the PRO: • A copy of the signed and dated FDA Form 1572 or DAIDS Investigator of Record Form (the original must remain at the site) • Signed and dated current CV of the IoR, in English (current within two years) • Documentation of approval from all relevant IRBs/ECs and RE, if applicable, of the study protocol, informed consent forms, and other required material such as recruitment material. This documentation must reference the protocol number, title, version number, and date as it appears on the cover page of the protocol. If the approval documentation provided by the IRB/EC is in a language other than English, both the non-English version and a translation into English must be submitted • Copy of the approved site-specific informed consent forms(English and any local language); the approved informed consent forms must include the protocol number, title, version number, and date as they appear on the cover page of the protocol • Back-translations of the local language site-specific informed consent forms (if applicable) See Figure 10-1 • A local language DAIDS Protocol Registration Translation Confirmation Document. Only one Translation Confirmation Document that attests to the accuracy of the translation of each language for all of the protocol registration documents is required with each protocol registration submission PRO staff will review all materials including a careful r...
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Related to Site-specific Protocol Registration

  • NERC Registration If and to the extent any of the NTO’s facilities are NERC jurisdictional facilities, the ISO will register for certain NERC functions applicable to those NTO facilities. Such functions may include, without limitation, those functions designated by NERC to be “Reliability Coordinator” and “Balancing Authority” and “Transmission Planner” and “Planning Coordinator.” The Parties agree to negotiate in good faith the compliance obligations for the NERC functions applicable to, and to be performed by, each Party with respect to the NTO’s facilities. Notwithstanding the foregoing, the ISO shall register for the “Transmission Operator” function for all NTO Transmission Facilities under ISO Operational Control identified in Appendix A-1 of this Agreement.

  • Bulk Registration Data Access to Icann Periodic Access to Thin Registration Data. In order to verify and ensure the operational stability of Registry Services as well as to facilitate compliance checks on accredited registrars, Registry Operator will provide ICANN on a weekly basis (the day to be designated by ICANN) with up-to-date Registration Data as specified below. Data will include data committed as of 00:00:00 UTC on the day previous to the one designated for retrieval by ICANN.

  • Domain Name Registration If Customer submits a Service Order(s) for domain name registration services, the following terms shall also apply:

  • USER REGISTRATION You may be required to register with the Site. You agree to keep your password confidential and will be responsible for all use of your account and password. We reserve the right to remove, reclaim, or change a username you select if we determine, in our sole discretion, that such username is inappropriate, obscene, or otherwise objectionable.

  • DIR Registration California Labor Code Section 1725.5 requires the Contractor and all subcontractors performing Public Works services to be currently registered with the DIR, as specified in California Labor Code Section 1725.5. California Labor Code Section 1771.1 provides that a contractor or subcontractor shall not be qualified to bid on, be listed in a bid proposal (subject to the requirements of Section 4104 of the California Public Contract Code), or engage in the performance of any contract for Public Work, unless currently registered and qualified to perform Public Work in accordance with California Labor Code Section 1725.5. Further information can be found on DIR’s website at xxxx://xxx.xxx.xx.xxx/Public-Works/Contractors.html. The above summary is provided solely for informational purposes and does not in any way affect the Contractor’s and subcontractors’ obligation to comply in all respects with all other applicable laws and regulations. The Contractor shall disseminate these provisions to all subcontractors. Before the performance of work by Contractor or any subcontractor(s) under this Contract, Contractor shall furnish Contractor’s and any subcontractors’ current DIR registration number(s). The Contractor’s current DIR registration number and the current DIR registration number of all subcontractors will be listed on the Subcontractor and LBE Participation Verification Form, incorporated herein.

  • AGREED FACTS Registration History 6. The Respondent was registered in the securities industry commencing in 1997.

  • Registration Process In connection with the registration of the Registrable Securities pursuant to Section 4.1, the Company shall:

  • Department of State Registration Consistent with Title XXXVI, F.S., the Contractor and any subcontractors that assert status, other than a sole proprietor, must provide the Department with conclusive evidence of a certificate of status, not subject to qualification, if a Florida business entity, or of a certificate of authorization if a foreign business entity.

  • Expenses of Registration All expenses incurred in connection with registrations, filings or qualifications pursuant to Sections 2 and 3, including, without limitation, all registration, listing and qualifications fees, printers, legal and accounting fees shall be paid by the Company.

  • Specific Preliminaries C1. Proprietary branded products The contractor shall take delivery of, handle, store, use, apply and/or fix all proprietary branded products in strict accordance with the manufacturer's instructions after consultation with the manufacturer's authorised representative. 95 F: ……….… V: ….……… T: ….……... Item C2. Trade Names, etc. All materials, fittings, finishings, etc., specified hereinafter under a trade name, catalogue number or reference, must be exactly as described. The Architect's approval in writing must be obtained for the use of any alternative to the specification before the submission of tenders otherwise the specified materials, fittings, finishings, etc., will be assumed to have been allowed for in the tender. The Contractor must take delivery of, handle, store, use, apply and/or fix all proprietary branded products in strict accordance with the manufacturer's instructions after consultation with the manufacturer's authorised representative. 96 F: ……….… V: ….……… T: ….……... Item C3. Contractors responsibility The Employer, the Principal Agent and the other professional consultants shall not be responsible for any act or omission on the part of the Contractor which may result in any patent or latent defects, in materials or workmanship, breach or neglect of any local regulations. The Contractor shall at all times be responsible for any such neglect, deviation or wrong act, whether the same is discovered before or after the final certificate, or any other Certificate, has been approved. 97 F: ……….… V: ….……… T: ….……... Item Carried to Collection R Section 1 Bill No. 1 Preliminaries C4. Overtime Should overtime be required to be worked for any reason whatsoever, the costs of such overtime are to be borne by the contractor unless the principal agent has specifically authorised in writing, prior to the execution thereof, that costs for such overtime are to be borne by the employer. 98 F: ……….… V: ….……… T: ….……... Item

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