Ind document level checklist
[DOC File]TEMPLATE: CLINICAL STUDY PROTOCOL
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For each written IND Safety Report, the Sponsor-Investigator will identify all previously submitted IND Safety Reports that addressed a similar suspected adverse reaction experience and will provide an analysis of the significance of newly reported, suspected adverse reaction in light of the previous, similar report(s) or any other relevant ...
[DOCX File]Guideline: Study Start-up to SIV and Site Activation
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This document identifies prerequisites for a) the scheduling of a site initiation visit and b) site activation (i.e., the authorization to begin subject recruitment). ... Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) ... A checklist of study-level quality review activities.
[DOCX File]Checklist: Review of Compliance
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The Methodology for Assessing Procurement Systems (MAPS)1 has been revised. It includes a validation and quality assurance mechanism that can be used by the country or the institution that carries out the assessment to ensure compliance with the MAPS methodology, quality and objectivity and as a result the external certification of MAPS assessments.
Ind Contractor Checklist
Part B is for high level researchers such as co-principal investigators on sponsored projects. ... I certify that the information provided in this document is correct. ... Ind Contractor Checklist Last modified by: Roper, Maria Company:
[DOC File]Sponsor-Investigator Research Requirements
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IND Determination: The convened Board will collectively review and complete the IND reviewer checklist at the designated meeting . The IRB will make a determination required by the regulations and document it in the minutes along with the protocol specific findings justifying those determinations
[DOC File]Investigational New Drug (IND) Submission checklist
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This information is repeated later in the IND, in a concise detail. First section: must include the name of drug, active ingredients, its pharmacological class, structural formula (if known), formulation of the dosage form(s) to be used, route of administration, and broad objectives and expected duration of the study.
[DOC File]Task Distribution Checklist
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Tool: Task Distribution Checklist Purpose: To identify who (at a group level) will be responsible for each of the various tasks associated with planning, executing, monitoring, analyzing, reporting, and archiving a clinical research study Audience/User: Lead Investigators, IND/IDE Holders (when applicable), and all others responsible for any of the delineated tasks on the list Details: This ...
[DOC File]MEMBER REVIEWER CHECKLIST - Research
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An IND is not required of the study is intended only to evaluate the dietary supplement’s effect on the structure or function of the body. However, if the study is intended to evaluate the dietary supplement’s ability to diagnose, cure, mitigate, treat, or prevent a disease, an IND . is. required.
IND Checklist
This checklist is intended to help you determine whether an IND is required, and to document the basis of your conclusion so that the IRB will be fully informed. EMERGENCY RESEARCH Do you plan to conduct a study of a drug or biologic involving an exception to the requirement that subjects give informed consent (ref. 21 CFR 312.2(b)(6) and 21 ...
[DOCX File]Regulatory Binder Checklist
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Jul 17, 2015 · This document clarifies the standard content of the Binder. It is the responsibility of the investigator to ensure compliance with Good Clinical Practice (GCP), institutional review board (IRB), and applicable regulatory requirements. This document serves as a template and may be modified for study-specific needs/requirements.
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