Investigator Documentation Sample Clauses

Investigator Documentation. Dermira shall ensure that no Investigator enrols any subject in any Phase 3 Study, or any Post-Approval Study in the Development Indication, unless and until Dermira has received: (a) from such Investigator the information and documentation required by Applicable Law as it applies to the selection of investigators, including 21 C.F.R. §§312.53 and 312.64 (or the equivalent regulations in the case of Investigators located outside of the United States); and (b) from the applicable Review Board written confirmation that the required Review Board approvals for a Phase 3 Study and any Post-Approval Study for the Development of the Product in the Development Indication in the Development Territory described in Section 5.8 have been received. Upon the completion or earlier termination of a Phase 3 Study, or a Post-Approval Study in the Development Indication, Dermira shall provide UCB with the original documents described in this Section 5.10(f).
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Investigator Documentation. Before beginning the study, the principal investigator will be asked to comply with ICH E6(R1) 8.2 and Title 21 of the Code of Federal Regulations (CFR) by providing the essential documents to the Sponsor or designee, which include but are not limited to the following: • An original investigator-signed investigator agreement page of the protocol; • The IRB/EC approval of the protocol; • The IRB- or EC-approved informed consent, samples of site advertisements for recruitment for this study, and any other written information regarding this study that is to be provided to the patient or legal guardians; • A Form FDA 1572, fully executed, and all updates on a new fully executed Form FDA 1572; • Curricula vitae for the principal investigator and each sub-investigator listed on Form FDA 1572. A curricula vitae and current licensure, as applicable, must be provided. The curricula vitae must have been signed and dated by the principal investigators and sub-investigators within 2 years before study start-up to indicate the documents are accurate and current; • Completed financial disclosure forms (Section 14.2) to allow the Sponsor or designee to submit complete and accurate certification or disclosure statements required under US Title 21 CFR 54. In addition, the investigators must provide to the Sponsor or designee a commitment to update this information promptly if any relevant changes occur during the course of the investigation and for 1 year following the completion of the study; • Laboratory certifications and normal ranges for any laboratories used by the site for the conduct of this study.
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Investigator Documentation. Prior to beginning the study, the investigator will be asked to comply with ICH E6(R2) Section 8.2 and US Title 21 of the CFR by providing essential documents, including but not limited to, the following: • IRB approval. • An original investigator-signed investigator agreement page of the protocol. • Form FDA 1572, fully executed, and all updates on a new fully executed Form FDA 1572. • Curriculum vitae for the principal investigator and each subinvestigator listed on Form FDA 1572. Current licensure must be noted on the curriculum vitae. Curriculum vitae will be signed and dated by the principal investigators and subinvestigators at study start-up, indicating that they are accurate and current. • Financial disclosure information to allow SIGA to submit complete and accurate certification or disclosure statements required under US Title 21 CFR Part 54. In addition, the investigators must provide to SIGA a commitment to promptly update this information if any relevant changes occur during the course of the investigation and for 1 year after the completion of the study. • An IRB-approved ICF, samples of site advertisements for recruitment for this study, and any other written information about this study that is to be provided to the subject or legal guardians. • Laboratory certifications and reference ranges for any local laboratories used by the site, in accordance with US Title 42 CFR Part 493.
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Investigator Documentation. Prior to beginning the study, the investigator will provide the following essential documents to AHPBA, including but not limited to: • An original investigator-signed Investigator Agreement page of the protocol • IRB approval of this protocol and informed consent form
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Related to Investigator Documentation

  • Product Documentation You should review the policy documents carefully to ensure they accurately reflect the cover, conditions, limits and other terms that you require. Particular attention should be paid to policy conditions and warranties as failure to comply with these could invalidate your policy. Claims can arise, under certain types of insurance contract, long after the expiry of the policy. It is therefore important that you retain and keep safely all documents associated with your policy.

  • Source Documentation Accounting records must be supported by such source documentation as canceled checks, bank statements, invoices, paid bills, donor letters, time and attendance records, activity reports, travel reports, contractual and consultant agreements, and subaward documentation. All supporting documentation should be clearly identified with the Award and general ledger accounts which are to be charged or credited. (i) The documentation standards for salary charges to grants are prescribed by 2 CFR 200.430, and in the cost principles applicable to the entity’s organization (Paragraphs 7.4 through 7.7). (ii) If records do not meet the standards in 2 CFR 200.430, then Grantor may notify Grantee in PART TWO, PART THREE or Exhibit G of the requirement to submit Personnel activity reports. See 2 CFR 200.430(i)(8). Personnel activity reports shall account on an after-the-fact basis for one hundred percent (100%) of the employee's actual time, separately indicating the time spent on the grant, other grants or projects, vacation or sick leave, and administrative time, if applicable. The reports must be signed by the employee, approved by the appropriate official, and coincide with a pay period. These time records should be used to record the distribution of salary costs to the appropriate accounts no less frequently than quarterly. (iii) Formal agreements with independent contractors, such as consultants, must include a description of the services to be performed, the period of performance, the fee and method of payment, an itemization of travel and other costs which are chargeable to the agreement, and the signatures of both the contractor and an appropriate official of Grantee. (iv) If third party in-kind (non-cash) contributions are used for Grant purposes, the valuation of these contributions must be supported with adequate documentation.

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