Essential Documents. This Contract, the Performance Frameworks (as discussed in further detail in Articles V through VIII below) including the annual performance indicators set under the Performance Frameworks together form the essential documents governing the Parties (“Essential Documents”). Goals set forth in the initial application or the renewal application shall be reviewed by the Parties as part of the basis for the negotiations of the Performance Frameworks as further described in Section VI below. Where appropriate, the conditions placed by the Authorizer on the School in the application of renewal process may become Performance Indicators in the annual Performance Frameworks in order to monitor the School’s compliance with the conditions.
Essential Documents. HPTN study sites must maintain a number of administrative and regulatory documents pertinent to each HPTN study in which they participate. These documents commonly are referred to as essential documents. Although sites are allowed some flexibility in their filing systems, all required documents should be stored in an organized manner and must be easily retrievable for review by the Clinical Site Monitor and other authorized individuals. Study sites are encouraged to begin organizing and filing required documentation upon receipt of the final study protocol and must maintain complete and accurate files from that time forward, in accordance with the record retention requirements stated in the study protocol. DAIDS requirements and additional guidance on management of essential documents is provided in the DAIDS SCORE Manual.
Essential Documents. This Contract, the Performance Frameworks and annual target goals set under the Performance Frameworks together form the essential documents governing the Parties (“Essential Documents”). The decision to renew the charter at the end of the term shall be based on these documents and data collected from the School’s performance on the Performance Frameworks.
Essential Documents. This Contract, the Performance Frameworks (as discussed in further detail in Articles V through VIII below) including the annual performance indicators set under the Performance Frameworks together form the essential documents governing the Parties ³(VVHQWLDO. G'oaRlsFseXt PforHthQinWthVe ´ini tial application or the renewal application shall be reviewed by the Parties as part of the basis for the negotiations of the Performance Frameworks as further described in Section VI below. Where appropriate, the conditions placed by the Authorizer on the School in the application of renewal process may become Performance Indicators in the annual Performance Frameworks LQ RUGHU WR PRQLWRU WKH 6FKRRO conditions.
Essential Documents. The Principal Investigator and clinical site personnel are responsible for maintaining an organized, comprehensive file of all essential documents required to demonstrate compliance with regulatory requirements. Such documents include, but are not limited to: • Protocol with all amendments, signed Principal Investigator Protocol Agreement(s) and informed consent form(s) • IB, including all updates • Copy of the signed FDA Form 1572 • CVs and medical licenses for the Principal Investigator and subinvestigators • IRB/IEC approval of the protocol and amendment(s), informed consent form(s) and any other study-related materials • IRB/IEC membership list or Letter of Assurance • Subject Screening and Enrollment Log, which may be obtained from EDC • IRB/IEC submissions of SAEs that have occurred at the institution and of INDSRs provided by the study’s sponsor • Laboratory certifications and reference ranges • Significant correspondence from VentiRx Pharmaceuticals or CRO • Other documents as required by local regulatory authorities These files must be available for inspection by VentiRx Pharmaceuticals, their representatives, the IRB/IEC, or regulatory authorities at any time.
Essential Documents. In addition to the supporting documents needed to perform the audit, the following documents serve as a basis (the list is not exhaustive): • grant agreement signed between the beneficiary and the Commission and its annexes; • any amendments made to the grant agreement; • the call for proposals under which the action was selected for funding, including the guide for applicants; • the present guidance note.
Essential Documents the Research and the documents necessary to confirm that the quality of the BBEST Information is consistent with Sections 8.1 to 8.4 of ICH Good Clinical Practice (“GCP”) .
Essential Documents. HPTN study sites must maintain a number of administrative and regulatory documents pertinent to each HPTN study in which they participate. These documents commonly are referred to as essential documents. Although sites are allowed some flexibility in their filing systems, all required documents should be stored in an organized manner and must be easily retrievable for review by the Clinical Site Monitor and other authorized individuals. Study sites are encouraged to begin organizing and filing required documentation upon receipt of the final study protocol and must maintain complete and accurate files from that time forward, in accordance with the record retention requirements stated in the study protocol. Guidance is provided in the DAIDS policy on essential documents.
Essential Documents. This Contract, the Performance Frameworks (as discussed in further detail in Articles V through VIII below) including the annual performance indicators set under the Performance Frameworks together form the essential documents governing the Parties (“Essential Documents”). Goals set forth in the initial application or the renewal application shall be reviewed by the Parties as part of the basis for the negotiations of the Performance Frameworks as further described in Section VI below. Where appropriate, the conditions placed by the Authorizer on the School in the application of renewal process may become Performance Indicators in the annual Performance Frameworks in order to monitor the School’s compliance with the conditions. Material Elements of Charter and Renewal Applications Incorporated. The material provisions of the renewal application have been incorporated as part of the Contract and are listed in Article VIII below.
