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Resources

“We can direct you.”

Resources

The following are a list of resources that may be helpful in the conduct of your research study.

FDA

Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors

Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs Improving Human Subject Protection

Guidance for Industry: Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs

Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

Guidance for Institutional Review Boards (IRBs) Frequently Asked Questions – IRB Registration

FDA Code of Federal Regulations

FDA 510K Device Premarket Notification

Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: Frequently Asked Questions About Medical Devices

Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies

Search OHRP/FDA Database for Registered IRBs and Approved FWAs

Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure

DHHS/OHRP

Department of Health and Human Services Part 46: Protection of Human Subjects

OHRP Frequently Asked Questions

OHRP Guidance Documents

EPA

EPA Code of Federal regulations

ICH

Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance

Note: Click on the category you want to expand the list.

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