Prepared by FDAnews editors and researchers, Navigating Good Clinical Practices, 2006 Edition is your most comprehensive and authoritative source for current FDA rules, regulations and guidance on GCP and clinical trial management.

You get 600+ pages of smart, specific information on how to prepare for pre-investigation visits ... conduct research in emergency settings ... handle clinical holds and combination products ... manage data monitoring committees ... select control groups ... collect race and ethnicity information ... and much more.

New for 2006:

• Answers to frequently asked questions about the FDA’s expectations on GCP
• Guidance on compliance with 21 CFR Part 11
• Information on how FDA uses its authority to impose clinical holds on studies, including the use of a hold following clinical investigation misconduct
• Best practices for keeping meticulous records that adhere to all FDA regulations
• Steps to take to ensure that the rights, safety and well-being of trial subjects are protected while maintaining the credibility of your clinical trial data
• Coverage of the FDA’s expectations for the implementation and reporting requirements of clinical trial data monitoring committees
• The FDA and International Conference on Harmonisation guidance on harmonized GCPs
• Step-by-step recommendations for sponsors holding investigational new drug applications, new drug applications and biologics license applications on when to submit data ... which submission formats may be used ... and how data will be used for regulatory decision-making
• The FDA’s current thinking on conducting safety assessments of medical imaging agents.

Table of Contents
Volume I

Section 1: Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators

This guidance explains what FDA expects for Good Clinical Practices and includes answers to frequently asked questions.

Section 2: Part 11, Electronic Records; Electronic Signatures Scope and Application

The guidance narrows the FDA's interpretation of the scope of Part 11, defining Part 11 records and revising the FDA's approach to specific Part 11 requirements.

Section 3: The Use of Clinical Holds Following Clinical Investigation Misconduct

The guidance provides information on FDA's use of its authority to impose a clinical hold on a study.

Section 4: E10 Choice of Control Group and Related Issues in Clinical Trials

FDA/ICH guidance for industry, including discussion of types of controls.

Section 5: Collection of Race and Ethnicity Data in Clinical Trials

This guidance recommends a standardized approach for collection of race and ethnicity information in clinical trials conducted in the U.S. and abroad for certain FDA regulated products.

Section 6: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions

Guidance for industry, including explanation of statutory requirements and implantation issues, and information for sponsors who submit information required by the Best Pharmaceuticals for Children Act.

Section 7: Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms

This guidance provides recommendations to industry for studies of estrogen and estrogen/progestin drug products.

Section 8: Handling and Retention of BA and BE Testing Samples

FDA guidance on bioavailability (BA) and bioequivalence (BE), including a review of sampling techniques and needs in different settings.

Section 9: E6: Good Clinical Practice: Consolidated Guidance

FDA/ICH guidance on internationally harmonized GCPs.

Section 10: Guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data

This guidance recommends regulatory and development strategies to permit clinical data collection in one region to be used for the support of drug and biologic registrations in another region while allowing for the influence of ethnic factors.

Volume II

Section 1: Establishment and Operation of Clinical Trial Data Monitoring Committees

FDA draft guidance for clinical trial sponsors, including how to determine the need for a committee, how to run it and how to report requirements.

Section 2: Guideline for the Monitoring of Clinical Investigations

The guidance includes advice on selecting a monitor and preparing for pre-investigation visits.

Section 3: Guidance for Institutional Review Boards, Clinical Investigators and Sponsors: Exception From Informed Consent Requirements for Emergency Research

This guidance includes information on the development and implementation of research in emergency settings and defines responsibilities for FDA communications.

Section 4: Acceptance of Foreign Clinical Studies

The FDA guidance includes the effects of the Declaration of Helsinki.

Section 5: IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer

This guidance provides the FDA's current thinking on when studies of marketed cancer products are exempt from IND regulation based on a risk assessment.

Section 6: Pharmacogenomic Data Submissions

The guidance provides recommendations to sponsors holding INDs, NDAs, and BLAs on when to submit data, what formats may be used for submissions and how the data will be used in regulatory decision-making.

Section 7: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

This guidance discusses when studies should be conducted, recommended design and conduct, inclusion criteria for patient populations, analysis, interpretation and reporting of the results.

Section 8: Estimating the Safe Starting Dose in Clinical Trials for Therapeutics in Adult Healthy Volunteers

The guidance outlines an algorithm and vocabulary for deriving the maximum recommended MRSD for "first in human" clinical trials of new molecular entities in adult health volunteers and recommends a standardized process by which the MRSD is selected.

Section 9: Medical Imaging Drug and Biological Products
Part 1: Conducting Safety Assessments;
Part 2: Clinical Indications; and
Part 3: Design, Analysis, and Interpretation of Clinical Studies

Guidance’s describe the FDA's current thinking on how to conduct safety assessments of medical imaging agents.

Section 10: Exposure-Response Relationships — Study Design, Data Analysis and Regulatory Applications

The guidance describes the uses of exposure-response studies, the importance of ensuring valid information, the strategy for prospective planning and data analysis, the integration of assessment and the format and content for reports.