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[DOC File]FDA Investigator Responsibility Checklist
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FDA Regulatory Binder and PI Responsibility Requirements. The following checklist details the investigator responsibilities outlined in the FDA Code of Federal Regulations 21 CFR 312 (drugs/biologics) and 812 (devices). The purpose of this checklist is to clarify which documents are needed to provide evidence that the investigator has fulfilled his or her responsibilities in conducting a ...
ind document level checklist

Word Document Checklist - Food and Drug Administration
Word Document Checklist Page 1. FDA 06/29/11. Title: Word Document Checklist Subject: 508 Checklist for Word documents Author: OC/OIM/DBPS/IIB Keywords: checklist, word, …
ind application checklist

[DOC File]SITE FDA INSPECTION PREPARATION CHECKLIST
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Routine (e.g., IND): Details: Directed (e.g., for cause): Follow-up (e.g., 483; warning letters): Other: Does the FDA want specific personnel available? If yes, please list. Use a separate sheet if needed. Who: When: Does the FDA want specific documents available? If yes, please list. Use a separate sheet if needed. Document requested: Check if requested prior to inspection. If the FDA ...
ind submission checklist

[DOC File]Investigational New Drug (IND) Submission checklist
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If utilizing a drug that is currently subject to a manufacturer’s IND, or marketing application, refer to that IND or application or Drug Master File (if appropriate) to prevent duplicating information that are already available to FDA. Include a Letter of Authorization from the other sponsor permitting FDA to use their information for this IND. The Sponsor also must file a copy of the ...
ind submission requirements fda

[DOC File]Content and Format of an Investigational New Drug (IND ...
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An IND goes into effect (a) thirty (30) days after the FDA receives the IND, unless the FDA notifies the sponsor that the clinical investigations described in the IND are subject to a “clinical hold”; or (b) upon earlier notification by FDA that the clinical investigation described in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND. An investigator ...
ind study audit checklist

[DOC File]IND APPLICATION EXEMPTION CHECKIST
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This checklist is intended to assist the investigator in determining whether an IND application needs to be submitted to the FDA for studies involving FDA-approved drugs. Answer each question below. If any question is answered “yes”, an IND application must be submitted to the FDA. If the answer to All questions are “no”, then the study may meet the criteria for an exemption from an ...
new drug application checklist

Study Data Standardization Plan Checklist CDISC ...
This checklist may be used during IND meetings (e.g., pre-IND, end-of-phase-1, end-of-phase-2, prior to pivotal trial and pre-BLA). The SDSP checklist may be used during the clinical trial life ...
ind submission template

[DOCX File]Use this checklist to verify sponsor and investigator ...
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University of Pittsburgh IND Sponsor-Investigator Checklist. 6. A sponsor-investigator assumes BOTH investigator and sponsor responsibilities as outlined in the FDA Code of Federal Regulations 21 CFR 312. This means that such investigators have additional responsibilities. Use this checklist to verify sponsor and investigator responsibilities at the onset and during the course of your study ...
documents required for ind submission

[DOC File]IND Applicability Checklist
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Tool: IND Applicability Checklist Purpose: This checklist can be used to help investigators determine whether US Investigational New Drug (IND) regulations apply to their research project. Audience/User: Clinical Investigators, site study coordinators, OCTOM, and CROMS. Details: The criteria listed here are specified in IND regulations at 21 CFR 312.2(b)(1). Best Practice Recommendations and ...
ind document level checklist

IND Checklist
However, in certain circumstances, FDA does not require an IND. 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 ...
ind application checklist

Fda ind checklist