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Guidances, Information Sheets, and Important Notices on
Good Clinical Practice in FDA-Regulated Clinical Trials

These guidances and information sheets represent the Agency's current guidance on good clinical practice and the conduct of clinical trials. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. However, in many places throughout these documents, specific regulations are cited and the requirements of the regulations are reiterated. The regulations are enforceable.

Notices contained on this page are those that have been published by the Agency that contain important information about good clinical practices and the conduct of clinical trials.

Guidances

FDA Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors

Information Sheet Guidances represent the agency's current guidance on protection of human subjects of research. Through the FDA Information Sheet Guidance Initiative, information intended to help IRBs, clinical investigators and sponsors fulfill their responsibilities to protect human subjects will be periodically updated. The process of rescinding, revising, and reissuing all of the existing Information Sheets (there are approximately 40) may take several years to complete. The agency plans to make the process as transparent as possible. Therefore, FDA advises users to periodically check this web site for revisions throughout this time period.

FDA/NCI MOU Regarding Common Standards-based Data Repository

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) of the Department of Health and Human Services (DHHS). The purpose of this MOU is to establish a formal collaboration between FDA and NCI regarding the creation of a common standards-based data repository to facilitate the electronic exchange and analysis of data from research studies on investigational drugs in a fully secure manner

Federal Register (April 18, 2007, Volume 72, Number 74) [Federal Register in PDF format]

Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection

HHS Secretary Tommy G. Thompson today released new guidance for protecting research subjects from possible harm caused by financial conflicts of interest in research studies. The guidance document entitled "Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection," is for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties as announced in Federal Register, Vol. 69, No.92, May 12, 2004, Page 26393. It applies to all human subjects research conducted or supported by HHS agencies or regulated by the Food and Drug Administration.

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

This guidance is intended to provide assistance to the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the IRB.

Federal Register Notice | Federal Register Notice in PDF format

Guidance for Clinical Investigators, Institutional Review Boards and Sponsors Process for Handling Referrals to FDA under 21 CFR 50.54 [PDF, 75KB]

This guidance is intended to assist clinical investigators, Institutional Review Boards (IRBs), sponsors, and other interested parties in understanding the FDA's process for handling clinical investigations that include children as subjects and that have been referred to FDA for review under 21 CFR 50.54.

Federal Register (December 22, 2006, Volume 71, pp. 77034-77035) [Federal Register in PDF format]

Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees [PDF, 193KB]

The guidance entitled "Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees" dated March 2006 is intended to assist sponsors of clinical trials in determining when a data monitoring committee (DMC) is needed for study monitoring, and how such committees should operate. The guidance announced in this notice finalizes the draft guidance entitled "Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data Monitoring Committees" dated November 2001.

Federal Register (March 28, 2006; Volume 71, Number 59) [Federal Register in PDF format]

Guidance for Industry: Acceptance of Foreign Clinical Studies

This guidance clarified the versions of the Declaration of Helsinki that applies to FDA's acceptance of a foreign clinical study not conducted under an investigational new drug application (IND).

Guidance for Industry: Available Therapy

This guidance is intended to provide guidance to industry on the meaning of the term "available therapy" as currently used by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the FDA in the specific circumstances described in the guidance.

Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials [PDF]

This guidance recommends using a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products. The recommended standardized approach was developed by the Office of Management and Budget (OMB). The guidance lists the OMB categories for race and ethnicity and describes FDA's reasons for recommending the use of these categories. In addition, this guidance recommends a format for race and ethnicity data within study data that are submitted in standardized data sets such as the Study Data Tabulation Model or in the electronic Common Technical Document (eCTD)."

Guidance for Industry: Computerized Systems Used in Clinical Investigations (53KB PDF)

This guidance provides recommendations to sponsors, contract research organizations, data management centers, clinical investigators and institutional review boards regarding the use of computerized systems in clinical investigations.

Federal Register Notice [Federal Register Notice in PDF format]

Guidance for Industry: Development and Use of Risk Minimization Action Plans (83 KB PDF)

The Guidance as a Microsoft Word document.

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled `"Development and Use of Risk Minimization Action Plans''. The guidance provides guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidance addresses the development, implementation, and evaluation of risk minimization action plans for drug products.

(Federal Register (Vol. 70, March 29, 2005, pp.15866-15867) [Federal Register in PDF format]

Guidance for Industry Exploratory IND Studies

This guidance describes the preclinical and clinical issues as well as chemistry, manufacturing and controls information that should be considered when planning exploratory studies including studies of related drugs or biologics under an investigational new drug (IND) application.

(Federal Register [PDF])

Guidance for Industry: Financial Disclosure by Clinical Investigators

This guidance addresses questions received by FDA concerning the implementation of the final rule on financial disclosure (21 CFR 54). The financial disclosure regulations were intended to ensure that financial interests and arrangements of clinical investigators that could affect the reliability of data submitted to FDA were identified and disclosed to FDA by the applicant.

Guidance for Industry: Food-Effect Bioavailability and Fed Bioequivalence Studies

This guidance provides recommendations to sponsors and/or applicants planning to conduct food-effect bioavailability (BA) and fed bioequivalence (BE) studies for orally administered drug products as part of investigational new drug applications (INDs), new drug applications (NDAs) and abbreviated new drug applications (ANDAs), and supplemental applications.

The Guidance in PDF format

The Guidance as a Word document.

Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment (220 KB PDF)

The Guidance as a Microsoft Word document.

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.'' This guidance provides guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidances addresses good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data.

Guidance for Industry: Guideline for the Monitoring of Clinical Investigators

This guidance addresses issues pertaining to approached to monitoring clinical investigations.

Guidance for Industry: Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (1.83 MB PDF)

This guideline presents guidance on FDA's expectations regarding inclusion of both genders in drug development.

(For help in viewing this document, contact the HHS Help Desk.)

Guidance for Industry on Handling and Retention of Bioavailability and Bioequivalence Testing Samples; Availability (166KB PDF)

The Guidance as a Microsoft Word document.

Pre-Pub version (23KB PDF)

Inspection of clinical and analytical sites that perform bioavailability (BA) and bioequivalence (BE) studies frequently reveals the absence of reserve samples at the testing facilities where the studies are conducted. The guidance is intended to clarify how to distribute test articles and reference standards to testing facilities, how to randomly select reserve samples, and how to retain reserve samples."

Guidance for Industry: IND Exemptions for Studies of Lawfully Marketed Drug or Biologicial Products for the Treatment of Cancer (188 KB)

The Guidance as a Microsoft Word document.

This guidance is intended to assist sponsors in deciding whether a study of marketed drugs or biological products for treating cancer falls within the exemption under § 312.2(b)(1) (21 CFR 312.2(b)(1)) from the general requirement to submit an investigational new drug application (IND).

Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions (46 KB PDF)
Text version of draft guidance

This guidance is intended to assist sponsors who will be submitting information to the Clinical Trials Data Bank. It addresses statutory and procedural issues for submitting information to the data bank.

Guidance for Industry: IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations (614 KB PDF)

This guidance provides clarification for IRBs of their responsibilities for reviewing and approving stand-alone authorizations under the HIPAA Privacy Rule.

(For help in viewing this document, contact the HHS Help Desk.)

(Additional HIPAA guidances can be found on the Department of Health and Human Service's (DHHS) Office of Civil Rights (OCR) website.)

Guidance for Industry on Part 11, Electronic Records; Electronic Signatures--Scope and Application [215 KB PDF]

This guidance is intended to describe the FDA's current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). (For help in viewing this document, contact the HHS Help Desk.)

(Federal Register, Vol. 68, Sept. 5, 2003, pp. 52779-52781)

Guidance for Industry and FDA Staff: General Principles of Software Validation

The Guidance in PDF format.

Although the primary purpose of this guidance outlines general validation principles that the FDA consider to be application to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices, it contains useful validation principles that can be applied to software used in the conduct of clinical trials.
http://www.fda.gov/cdrh/comp/guidance/938.pdf

Guidance for Industry: Pharmacogenomic Data Submissions [96 KB PDF]

The Guidance as a Microsoft Word document.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Pharmacogenomic Data Submissions.'' The guidance provides recommendations to sponsors holding investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) on what pharmacogenomic data to submit to the agency during the drug development process, the format of submissions, and how the data will be used in regulatory decision making. The guidance is intended to facilitate scientific progress in the area of pharmacogenomics.

Attachment to Guidance [PDF].
Attachment as a Microsoft Word document

(Federal Register, Vol. 70, March 23, 2005, pp. 14698-14699. Also available as PDF.)

Guidance for Industry: Premarketing Risk Assessment [91 KB PDF]

The Guidance as a Microsoft Word document.

The Food and Drug Administration (FDA) is announcing the availability of the guidance for industry entitled "Premarketing Risk Assessment.'' This guidance provides guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidances addresses premarket risk assessment.

Guidance for Industry: Providing Regulatory Submissions in Electronic Format- Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

The Guidance in PDF format.

FDA is announcing the availability of this guidance for industry. This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This guidance discusses issues related to the electronic submission of new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), master files, advertising material, and promotional labeling using the electronic common technical document (eCTD) specifications.

Federal Register Notice of Availability

Federal Register Notice in PDF format]

Guidance for Industry and Clinical Investigators on the Use of Clinical Holds Following Clinical Investigator Misconduct [PDF]

This guidance for industry and clinical investigators provides information on one by FDA's of its authority to impose a clinical hold on a study or study site if FDA finds that human subjects are or would be exposed to unreasonable and significant risk of illness or injury.

Federal Register Notice of Availability

[Federal Register Notice in PDF format]

Guidance for Industry on Using a Centralized IRB Process in Multicenter Clinical Trial

The Guidance in PDF format.

This guidance is intended to assist sponsors, institutions, institutional review boards (IRBs), and clinical investigators involved in multicenter clinical research in meeting the requirements of 21 CFR part 56 by facilitating the use of a centralized IRB review process (use of a single central IRB), especially in situations where centralized review could improve efficiency of IRB review.

Federal Register (March 16, 2006, Volume 71, Number 51)

Pre-publication Notice [PDF]

Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials

Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable

The Guidance in PDF format.

FDA is issuing this guidance to inform sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for informed consent when human specimens are used for FDA regulated in vitro diagnostic device investigations.

Information responsive to the Paperwork Reduction Act.

ICH Guidances

ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports (PDF 240 KB)

This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects. The guideline is intended to assist sponsors in the development of a report that is complete, free from ambiguity, well organized and easy to review.

ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data

This International Conference on Harmonization (ICH) document makes recommendations for strategies to permit clinical data collected in one region to be used to support drug and biologic registrations in another region while allowing for the influence of ethnic factors.

ICH E6: Good Clinical Practice: Consolidated Guidance(PDF, 261 KB)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.
This document in Spanish.
(For help in viewing these documents, contact the HHS Help Desk.)

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

This International Conference on Harmonization (ICH) guidance addresses the choice of control group in clinical trials, discussing five principal types of controls, two important purposes of clinical trials, and the issue of whether a trial could have detected a difference between treatments when there was a difference (assay sensitivity).

ICH Q9: Quality Risk Management

The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements.

Notices

FDA announces Clinical Trials Transformation Initiative

FDA/NCI MOU on data repository

Pilot program for the submission of electronic case report forms in XML format
[PDF format]

New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring


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