RESOURCES
Ethical Principles and Guidelines for the Protection of Human Subjects of Research
The Belmont Report - explains the unifying ethical principles that form the basis of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research’s topic-specific reports and the regulations that incorporate its recommendations.
The Nuremberg Code - sets research ethics principles for human experimentation.
Declaration of Helsinki - a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.
Performance Scales
Eastern Cooperative Oncology Group (ECOG) Performance Status - used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Karnosfky Performance Status - used to compare effectiveness of different therapies and to assess the prognosis in individual patients.
Common Toxicity Criteria
Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria
National Cancer Institute (NCI) National Cancer Evaluation Program (CTEP) Common Toxicity Criteria
Food and Drug Administration
Draft Guidance for IRBs Conducting Continuing Review - When first drafted in 1981, these guidances were written in reference to single-site studies, the industry norm at the time. According to the FDA, multi-site studies are becoming much more prevalant, and therefore revisions are necessary to provide more oversight.
-Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Adverse Event Reporting - Improving Human Subject Protection; Availability
FDA-2004-N-0117 - Institutional Review Boards; Registration Requirements
FDA Forms 1571 & 1572 - must be submitted with Investigation New Drug Applications (IND) to the FDA.
Proposed Rule for Medical Device Data Systems - recent Federal Register notice on the FDA's proposal to reclassify the Medical Device Data System (MDDS) from class III (premarket approval) to class I (general controls).
Draft Guidance for Industry: Providing Regulatory Submission in Electronic Format -- Drug Establishment Registration and Drug Listing - intended to assist persons making regulatory submission to FDA in electronic format.
Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials:Final Rule - amends the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements.
Guidance for Industry: CGMP for Phase 1 Investigational Drugs - provides guidance to assist in applying current good manufacturing practice (CGMP) in the manufacture of most investigational new drugs (IND) used in phase 1 clinical trials.
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBS - a draft guidance, Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572), to assist those involved in studies of investigational drugs and biologics to complete the Statement of Investigator form (FDA-1572).
Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products - a draft guidance to provide to manufacturers of cellular and gene therapy products recommendations for developing tests to measure potency.
Draft Guidance for Industry: Nonclinical Evaluation for Anticancer Pharmaceuticals- a draft guidance to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals.
Qualification of Novel Methodologies for Drug Development: Guide to Applicants- a new, voluntary, scientific pathway leading to either a Committee for Medical Products for Human Use (CHMP) opinion or a Scientific Advice on innovative methods on drug development tools.
Regulations
Health Insurrance Portability and Acountability Act (HIPAA) - establishes a set of national standards for the protection of certain health information.
International Conference on Harmonization (ICH) - brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
Good Clinical Practice (GCP) - are standards on how clinical trials should be conducted.
Other
Clinical Trials Transformation Initiative - public-private partnership between the FDA and Duke University aimed at modernizing the way clinical trials are conducted. |
