What is BIMO General Procedures for BIMO

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РЕГИСТРАЦИЯ

What is BIMO?

What is BIMO?

General Procedures for BIMO Compliance Program Implementation

General Procedures for BIMO Compliance Program Implementation

Entities Involved in FDA-Regulated Research: Study Sponsor

Entities Involved in FDA-Regulated Research: Study Sponsor

Entities Involved in FDA-Regulated Research: Study Monitor

Entities Involved in FDA-Regulated Research: Study Monitor

Entities Involved in FDA-Regulated Research: Study Investigator

Entities Involved in FDA-Regulated Research: Study Investigator

Entities Involved in FDA-Regulated Research: IRB

Entities Involved in FDA-Regulated Research: IRB

Entities Involved in FDA-Regulated Research: Study Subject

Entities Involved in FDA-Regulated Research: Study Subject

Obligations of Study Sponsors 21 CFR 312, 21 CFR 812

Obligations of Study Sponsors 21 CFR 312, 21 CFR 812

Obligations of Study Sponsors 21 CFR 312, 21 CFR 812

Obligations of Study Sponsors 21 CFR 312, 21 CFR 812

Obligations of Study Sponsors 21 CFR 312, 21 CFR 812

Obligations of Study Sponsors 21 CFR 312, 21 CFR 812

BIMO Inspection Focus

BIMO Inspection Focus

Clinical Study Organization & Personnel: Contractors

Clinical Study Organization & Personnel: Contractors

Clinical Study Organization & Personnel: Clinical Research Dept

Clinical Study Organization & Personnel: Clinical Research Dept

Clinical Study Organization & Personnel: Study Investigators

Clinical Study Organization & Personnel: Study Investigators

Clinical Investigator Selection & Monitoring Assessment

Clinical Investigator Selection & Monitoring Assessment

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Clinical Investigator Selection & Monitoring: Investigator Files

Monitoring Procedures & Activities Assessment

Monitoring Procedures & Activities Assessment

Monitoring Procedures & Activities: Subject Data Line Listings

Monitoring Procedures & Activities: Subject Data Line Listings

Monitoring Procedures & Activities: Data Queries

Monitoring Procedures & Activities: Data Queries

Monitoring Procedures & Activities: Adverse Events

Monitoring Procedures & Activities: Adverse Events

Monitoring Procedures & Activities: Protocol Deviations

Monitoring Procedures & Activities: Protocol Deviations

Data Collection & Handling Assessment

Data Collection & Handling Assessment

Data Collection & Handling: Clinical Study Summary

Data Collection & Handling: Clinical Study Summary

Data Collection & Handling: Data Management Plan & Procedures

Data Collection & Handling: Data Management Plan & Procedures

Data Collection & Handling: Statistical Analysis Plan & Procedures

Data Collection & Handling: Statistical Analysis Plan & Procedures

Data Collection & Handling: Data Tables Confirmation

Data Collection & Handling: Data Tables Confirmation

Investigational Product Accountability Assessment

Investigational Product Accountability Assessment

Investigational Product Accountability: Product Distribution

Investigational Product Accountability: Product Distribution

Conclusion

Conclusion

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